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Purpose of Review: Two commonly used quality of life (QoL) questionnaires in lung cancer patients are the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) and the Functional Assessment of Cancer Therapy-Lung (FACT-L). More recently, the EORTC QLQ-LC29 was developed. This systematic review compares the EORTC QLQ-LC29, EORTC QLQ-LC13 and FACT-L in terms of the content, validity and psychometric properties in assessing the QoL of lung cancer patients., Recent Findings: Fourteen studies were included. The EORTC QLQ-LC29 is a 29-item scale that serves as an update of the EORTC QLQ-LC13 to include symptoms from surgery and new targeted therapies. It shows validity, high internal consistency, test-retest reliability, and sensitivity. The FACT-L continues to assess general quality of life and lung cancer-specific symptoms., Summary: The EORTC QLQ-LC29, EORTC QLQ-LC13, and FACT-L were reviewed to assess their validity in measuring QoL of lung cancer patients. All were found to be sufficiently validated, The choice of which to use should depend on the primary goals of the study., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose of Review: Two commonly used quality of life questionnaires in breast cancer are EORTC QLQ-BR23, the FACT-B, and the extended FACT-B + 4. More recently, the EORTC EORTC QLQ-BR42 was developed. This systematic review compares the various versions of the EORTC QLQ and FACT tools for breast cancer in terms of their content, validity, and psychometric properties., Recent Findings: Thirty-six studies met the inclusion criteria. All questionnaires have been proven to be valid, reliable and responsive. The provisional EORTC QLQ-BR45 transitioned to the EORTC QLQ-BR42 in Phase IV of its development, which encompasses the side effects associated with the latest breast cancer treatments. Both the EORTC and FACT measures assess physical and mental dimensions of quality of life, with the EORTC measure placing relatively more emphasis on physical content and FACT placing relatively more emphasis on mental (social and emotional) content. The four additional items in the FACT-B + 4 were developed to address arm lymphoedema following axillary surgery., Summary: The development and uptake of quality of life tools are essential in the evaluation of breast cancer treatments. The EORTC QLQ-BR42 and FACT-B are both valid, reliable, and responsive QoL questionnaires., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose of Review: This review aims to address the gap in radiation therapy (RT) care for elderly cancer patients. It will discuss the barriers to implementing effective RT in elderly and frail patients with a focus on breast cancer and metastatic settings., Recent Findings: Recent studies indicate that SBRT provides better pain control for bone metastases compared to cEBRT, but elderly patients are underrepresented in these trials. Evidence on the effectiveness of geriatric assessment tools in predicting RT tolerance and toxicity is mixed, with some studies showing a correlation while others do not. Comprehensive geriatric assessments, though promising, are often impractical due to time and resource constraints., Summary: There is a critical need for more inclusive research to better understand the risks and benefits of RT in elderly patients. Developing streamlined geriatric assessment tools and integrating them into clinical practice can enhance treatment personalization. Future studies should prioritize elderly populations to generate robust data, thereby improving RT outcomes and quality of life for this growing patient group., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: Ductal carcinoma in situ (DCIS) of the breast is one of the most common pre-invasive cancers diagnosed in women. Quality of life (QoL) is extremely important to assess in studies including these patients due to the favorable prognosis of the disease. The primary objective of this systematic review was to compile a comprehensive list of QoL issues, all existing QoL assessment tools, and patient-reported outcome measures used to assess DCIS., Methods: A search was conducted on Ovid MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from inception to August 2023, using keywords such as "ductal carcinoma in-situ", "quality of life", and "patient-reported outcomes." QoL issues and QoL tools in primary research studies were extracted., Results: A total of 67 articles identified issues pertaining to patients with DCIS spanning physical, functional, and psychosocial QoL domains. Physical and functional issues observed in patients included pain, fatigue, and impaired sexual functioning. Psychosocial issues such as anxiety, depression, and confusion about one's disease were also common. QoL tools included those that assessed general QoL, breast cancer-specific tools, and issue-specific questionnaires., Conclusion: The current instruments available to assess QoL in patients with DCIS do not comprehensively capture the issues that are pertinent to patients. Thus, the modification of existing tools or the creation of a DCIS-specific QoL tool is recommended to ensure that future research will be sensitive towards challenges faced by patients with DCIS., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Previous literature has produced heterogeneous results on StrataXRT for prevention of acute radiation dermatitis (RD) in breast cancer. This pilot study aimed to assess the feasibility and efficacy of StrataXRT in a cancer center., Methods: The study consisted of five cohorts: (1) patients with large breasts treated with local radiation therapy (RT) either in the supine position or (2) the prone position, (3) patients receiving locoregional breast RT with any breast size, and (4) patients receiving chest wall RT, either locally or (5) locoregionally. The primary endpoint of the study was RD grade as assessed using the Common Terminology Criteria for Adverse Events. Secondary endpoints included incidence of moist desquamation (MD), patient- and clinician-reported skin assessments, patient quality of life as assessed by the Skindex-16, and patient satisfaction. These outcomes were compared with those from a published trial from the same institution assessing standard of care and Mepitel Film (MF) as prevention of breast RD., Results: Forty-five patients receiving RT to the breast or chest wall were enrolled. Two withdrew, leaving 43 evaluable patients. Overall, two (4.7%) patients had grade 3 RD, 14 (32.6%) had grade 2 RD, and 27 (62.8%) had grade 1 RD. Ten patients (23.3%) developed MD during/after RT., Conclusion: StrataXRT is effective in preventing grade 3 RD in patients, and the most promising results were observed within the prone cohort. Further research includes evaluating the efficacy of StrataXRT against the standard of care for the prophylaxis of RD., Trial Registration: The study protocol was registered at ClinicalTrials.gov (identifier: NCT05594498) on October 13, 2022., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: To provide a comprehensive assessment of various fractionation schemes in radiation therapy for breast cancer, with a focus on side effects, cosmesis, quality of life, risks of recurrence, and survival outcomes., Design: Systematic review and meta-analysis., Data Sources: Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (from inception to 23 October 2023)., Study Selection: Included studies were randomised controlled trials focusing on conventional fractionation (CF; daily fractions of 1.8-2 Gy, reaching a total dose of 50-50.4 Gy over 5-6 weeks), moderate hypofractionation (MHF; fraction sizes of 2.65-3.3 Gy for 13-16 fractions over 3-5 weeks), and/or ultra-hypofractionation (UHF; schedule of only 5 fractions)., Data Extraction: Two independent investigators screened studies and extracted data. Risk of bias and quality of evidence were assessed using the Cochrane Collaboration's tool and the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach, respectively., Data Synthesis: Pooled risk ratios (RRs) and hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using a random effects model. Heterogeneity was analysed using Cochran's Q test and I 2 statistic. Network meta-analysis was used to integrate all available evidence., Main Outcome Measures: The pre-specified primary outcome was grade ≥2 acute radiation dermatitis and late radiation therapy related side effects; secondary outcomes included cosmesis, quality of life, recurrence, and survival metrics., Results: From 1754 studies, 59 articles representing 35 trials (20 237 patients) were assessed; 21.6% of outcomes showed low risk of bias, whereas 78.4% had some concerns or high risk, particularly in outcome measurement (47.4%). The RR for grade ≥2 acute radiation dermatitis for MHF compared with CF was 0.54 (95% CI 0.49 to 0.61; P<0.001) and 0.68 (0.49 to 0.93; P=0.02) following breast conserving therapy and mastectomy, respectively. Hyperpigmentation and grade ≥2 breast shrinkage were less frequent after MHF than after CF, with RRs of 0.77 (0.62 to 0.95; P=0.02) and 0.92 (0.85 to 0.99; P=0.03), respectively, in the combined breast conserving therapy and mastectomy population. However, in the breast conserving therapy only trials, these differences in hyperpigmentation (RR 0.79, 0.60 to 1.03; P=0.08) and breast shrinkage (0.94, 0.83 to 1.07; P=0.35) were not statistically significant. The RR for grade ≥2 acute radiation dermatitis for UHF compared with MHF was 0.85 (0.47 to 1.55; P=0.60) for breast conserving therapy and mastectomy patients combined. MHF was associated with improved cosmesis and quality of life compared with CF, whereas data on UHF were less conclusive. Survival and recurrence outcomes were similar between UHF, MHF, and CF., Conclusions: MHF shows improved safety profile, cosmesis, and quality of life compared with CF while maintaining equivalent oncological outcomes. Fewer randomised controlled trials have compared UHF with other fractionation schedules, but its safety and oncological effectiveness seem to be similar with short term follow-up. Given the advantages of reduced treatment time, enhanced convenience for patients, and potential cost effectiveness, MHF and UHF should be considered as preferred options over CF in appropriate clinical settings, with further research needed to solidify these findings., Systematic Review Registration: PROSPERO CRD42023460249., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: no support from any organisation for the submitted work; IC has received consulting fees from Pfizer, Novartis, Eli Lilly, Seagen, Gilead, Astra Zeneca, Daiichi Sankyo, and Menarini StemLine and is a clinical board member of the European Society for Radiotherapy and Oncology (unpaid); JQC has received funding from the Canadian Institutes of Health Research and honorariums from Roche, Pfizer, Novartis, AstraZeneca, Well Doc Alberta, Merck, La Roche-Posay, Knight, Seagen, Oncology Education, and Gilead; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Bones are frequent sites of metastatic disease, observed in 30-75% of advanced cancer patients. Quality of life (QoL) is an important endpoint in studies evaluating the treatments of bone metastases (BM), and many patient-reported outcome tools are available. The primary objective of this systematic review was to compile a list of QoL issues relevant to BM and its interventions. The secondary objective was to identify common tools used to assess QoL in patients with BM, and the QoL issues they fail to address., Methods: A search was conducted on Ovid MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases between 1946 and 27 January 2023 with the keywords "bone metastases", "quality of life", and "patient reported outcomes". Specific QoL issues in original research studies and the QoL tools used were extracted., Results: The review identified the QoL issues most prevalent to BM in the literature. Physical and functional issues observed in patients included pain, interference with ambulation and daily activities, and fatigue. Psychological symptoms, such as helplessness, depression, and anxiety were also common. These issues interfered with patients' relationships and social activities. Items not mentioned in existing QoL tools were related to newer treatments of BM, such as pain flare, flu-like symptoms, and jaw pain due to osteonecrosis., Conclusions: This systematic review highlights that QoL issues for patients with BM have expanded over time due to advances in BM-directed treatments. If they are relevant, additional treatment-related QoL issues identified need to be validated prospectively by patients and added to current assessment tools., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Malignant spinal cord compression (MSCC) is an oncological emergency that may result in a devastating combination of malignancy and disability. Existing quality of life (QoL) questionnaires commonly used in MSCC literature (EORTC QLQ-C30, BM-22, Brief Pain Inventory, and Spine Oncology Study Group Outcomes) may not capture all the commonly reported symptoms and lack specificity to MSCC. The primary objective of this systematic review is to determine unmet patient needs and underreported QoL issues and compile a comprehensive list of QoL issues. The secondary objective of this review is to compile all existing QoL tools and questionnaires and determine whether any QoL issues are not addressed in the existing tools currently used in the literature., Methods: A literature search was conducted on Ovid MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases between 1946 and February 6, 2023, to compile all QoL issues and existing questionnaires used to assess QoL in patients with MSCC. All study designs were included given that they discussed QoL issues specific to patients with MSCC., Results: The results of this systematic review identified the most frequently discussed QoL issues in the literature studying MSCC. This included direct symptoms of MSCC such as back pain, paralysis, limb weakness/numbness, and urinary/bowel incontinence. Indirect symptoms coming from radiotherapy treatment such as dysphagia, painful swallowing, mouth pain, dry mouth, diarrhea, fatigue, and nausea/vomiting were also noted. Other symptoms resulting from corticosteroid treatment included difficulty sleeping, blurring of vision, weight gain, and mood disturbance. Patients also experienced psychosocial issues such as anxiety, depression, emotional distress, low self-esteem, concerns about dependence on others, concerns about getting home, and fear about their prognosis and future., Conclusion: This review highlights the QoL issues specific to patients with MSCC and QoL tools capturing these issues. Relevance of QoL issues identified in this systematic review must be prospectively validated by patients and healthcare professionals with experience in treating MSCC., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background and Objective: Leptomeningeal disease (LMD) is associated with poor survival and health-related quality of life (HRQoL). There is an urgent need for clinical research in this area to improve the outcomes. The purpose of this study is to summarize the areas of active clinical research in LMD, identify the knowledge gap, and suggest future research directions., Methods: A narrative review of clinical trials in LMD was conducted based on a search in clinicatrials.gov using the search term "leptomeningeal" under "condition or disease". Clinical trials in patients with LMD arising from solid malignancy that were labelled as "not yet recruiting", "recruiting", "enrolling by invitation" or "active, not recruiting" were included. Studies which were deemed to have significant impact on future research direction in LMD were selected for discussion., Key Content and Findings: A total of 38 clinical trials were included. Of these 38 trials, 19 are discussed in this review, with focus on their research questions and impact on future research directions. Most of the studies that were not selected for discussion focused on biomarker-driven interventions. Four key areas of research were identified, namely the (I) diagnosis, response assessment or molecular profiling of LMD (n=2); (II) advances in radiotherapy (n=3); (III) intrathecal treatment (n=13); (IV) novel drug carrier for systemic treatment (n=1). The research questions in the 19 discussed clinical trials included the tumour microenvironment of LMD, the role of novel molecular techniques in LMD, combination of radiotherapy with drugs, and cell-based immunotherapy. Among these 19 studies, 11 were phase 1 trials, 3 were phase 2 or phase 1/2 trials, 2 were phase 3 or phase 2/3 trials and the study phase was not reported in the remaining 3 studies. The existing knowledge gaps are discussed, including the lack of primary site-specific prognostic tools, cost-effectiveness studies, dedicated HRQoL assessment tools for LMD and sequencing of treatment., Conclusions: The current clinical trials in LMD offer the promise to improve the diagnosis and treatment outcomes of patients with LMD. More research is needed to overcome the potential hurdles in the current treatment and bridge the knowledge gaps as identified in this review, to improve patients' quantity and quality of survival.

Background: The then-test, also known as the retrospective pre- and post-test design method, is a measurement used to evaluate response shift. The method requires patients to assess their previous health-related quality of life (HRQoL) and provide a retrospective judgement based on their current perspectives. The then-test, however, has been criticized for its reliability and validity. The objective of this systematic review is to summarize the current literature for the use of the then-test for evaluating HRQoL in cancer patients and account for potential response shift effects., Methods: A literature search was conducted in May 2022 using MEDLINE, PubMed, and PsychINFO dated from 2005 to the time of the search. Studies were included if they (I) used the then-test and (II) involved a population of cancer patients (any cancer site)., Results: The literature search resulted in 16 studies, published between 2005 and 2020. All studies used the then-test to detect response shifts. The EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires were the most common assessments used to evaluate HRQoL. Of the 16 articles, 5 exclusively reported on breast cancer, 5 reported on prostate cancer, and the remaining included all cancer sites. Most studies looked at patients undergoing a combination of chemotherapy, radiotherapy, and hormonal therapy. The mean differences between the retrospective assessment at both 3 and 6 months were significant for various quality of life (QoL) dimensions. Patients in some studies recalled their pretreatment HRQoL (then-score) as better than the pretreatment baseline scores and others reported them as worse, both confirming the existence of a response shift., Conclusions: Our review demonstrates that the then-test measurement tool has been commonly used for the detection of response shift. Newer measures for response shift have become more accepted; the then-test, if used, should be used with caution considering its limitations and the emergence of more advanced methods.

Supportive oncodermatology is a burgeoning new field within dermatology tasked with caring for the unique dermatologic needs of patients with cancer. Patients with dermatologic adverse events (dAEs) from localized and systemic anti-cancer therapies commonly experience significant distress and reduced health-related quality of life (HRQoL). Emerging dAEs is often overlooked by clinicians and researchers, despite their considerable impacts on treatment completion and patient self-esteem. Specific HRQoL issues experienced by cancer patients with dAEs include psychosocial distress and treatment interruption or cessation. Existing HRQoL assessment indices unfortunately fall short when assessing HRQoL in patients with dAEs from anti-cancer therapies due to the lack of specificity to patients' symptoms and inability to fully encompass the unique needs of this population. Additionally, the variability in HRQoL assessments across studies is substantial, suggesting the need for a standardized HRQoL measure. Here, we review the burden of dAEs and the existing validated tools used to measure them, while outlining strategies for modification to achieve optimal HRQoL assessment in patients with dAEs from anti-cancer therapies and address the HRQoL gap in supportive oncodermatology. Amongst the current tools, Skindex-16 most closely addresses the required skin-specific HRQoL metrics, but still lacks a few key cancer-specific measures. Other general HRQoL tools are well-tailored to cancer patients, but lack skin-specific questions., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The acceleration of population aging calls for simple and effective interventions catered for older people. Gerontechnology, the combination of gerontology and technology, can promote quality of life in older adults. However, public health-related events incorporating information communication technology (ICT) for older people have seldom been evaluated., Objective: We reported the development and evaluation of two simple and brief digital health promotion games hosted at the annual Hong Kong Gerontech and Innovation Expo cum Summit (GIES) in 2018 and 2019 to promote well-being., Methods: Two game booths (Dinosaur Augmented Reality photo-taking in 2018, Sit-and-Stand fitness challenge in 2019) were designed by our interdisciplinary team. Four gaming technologies were employed: augmented reality, chroma key (green screen), motion detection and 3D modeling. Immediately after the game, we administered a brief questionnaire survey to assess participant satisfaction, happiness and perceived benefits, and collected qualitative data through observations and informal interviews., Results: Majority of 1,186 and 729 game booth participants in 2018 and 2019, respectively, were female (73.4% and 64.7%) and older adults (65.5 and 65.2%). Overall satisfaction toward the game booths was high (4.64 ± 0.60 and 4.54 ± 0.68 out of 5), with females and older adults reporting higher scores. Average personal and family happiness of participants in 2018 were 8.2 and 8.0 (out of 10). 90.3 and 18.4% of participants in 2019 chose one or more personal (e.g. enhance healthy living habits 62.4%, enhance personal happiness 61.6%) and family (e.g. enhance family happiness 15.6%, improve family relationships 10.8%) benefits of the game booth, respectively. Participants showed enthusiasm toward the technologies, and pride in their physical abilities in the fitness challenge., Conclusion: Our report on the development and evaluation of brief game interventions with ICT showed high satisfaction and immediate perceived benefits in community participants. Females and older adults reported higher satisfaction. Simple tools measuring happiness and perceived benefits showed positive results. Older adults were receptive and enthusiastic about the new technologies. Our findings can inform researchers and organizers of similar events. More research on simple and enjoyable ICT interventions is needed to attract older adults and promote their well-being., Trial Registration: The research protocol was registered at the National Institutes of Health (Identifier number: NCT03960372) on May 23, 2019., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Sit, Lai, Kwok, Wong, Wong, Chow, Kwok, Wang, Ho and Lam.)

Purpose: Breast cancer patients receiving adjuvant radiotherapy (RT) benefit from local control. However, RT can give rise to increased fatigue, lowering quality of life. The aim of this study was to prospectively identify trends and risk factors in patient-reported fatigue associated with breast RT., Material and Methods: Patients were assessed using the Edmonton Symptom Assessment Scale (ESAS) before, once per week during RT, up to 6 weeks after RT completion, and 1-3 months post RT. Patients were included in the analysis if the ESAS was completed before, at least once during, and at least once after RT., Results: A total of 651 patients were included. Fatigue scores increased significantly during weeks 1-3 (p < 0.001) and weeks 5-6 (p < 0.0001) during RT compared to baseline. After RT completion, fatigue scores did not change significantly compared to baseline. Mastectomy patients who received previous chemotherapy experienced significantly more fatigue compared to mastectomy patients without previous chemotherapy (p = 0.0002). Patients less than 50 (p = 0.002), 50-59 (p = 0.007), or 60-69 (p = 0.048) years of age at RT start were more likely to have higher proportions of moderate or severe fatigue compared to patients ≥ 70 years of age., Conclusions: Fatigue associated with breast irradiation increased up to 6 weeks during RT and returned to near baseline scores at 1-3 months post treatment. Given that fatigue was significant in mastectomy patients, further research is needed to reduce fatigue among this cohort, especially those who have received previous chemotherapy and younger patients who are receiving breast RT., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Patients who receive radiation treatment (RT) for breast cancer often report pain, which contributes negatively to quality of life (QoL)., Aims: To identify demographic, treatment, and disease characteristics associated with pain and changes in pain before and after RT using the Edmonton Symptom Assessment Scale (ESAS)., Design: Retrospective study., Settings: Odette Cancer Centre., Participants: Patients diagnosed with nonmetastatic breast cancer from January 2011-June 2017 with at least one ESAS completed pre-RT and one completed post-RT., Methods: Data on systemic treatment, radiation, patient demographics, and disease stage were extracted. To identify factors associated with pain before and after RT and changes in pain, univariate and multivariate general linear regression analysis were conducted. p < .05 was considered statistically significant., Results: This study included 1,222 female patients with a mean age of 59 years. ESAS was completed an average of 28 days before RT (baseline) and 142 days after RT, respectively. In multivariable analysis, higher baseline pain scores were associated with having recently completed adjuvant chemotherapy (p = .002) and eventual receipt of locoregional (p = .026) or chest wall (p = .003) radiation. Adjuvant chemotherapy (p = .002) and chest wall radiation (p = .03), were associated with a significant reduction in pain score after radiotherapy, while locoregional RT was associated with a higher pain score after RT (p < .001)., Conclusions: Patients with locoregional RT had higher baseline pain that remained elevated after RT completion and should be screened for pain and provided with pain management and support when necessary., (Copyright © 2021. Published by Elsevier Inc.)

Purpose: Breast cancer patients receiving radiotherapy (RT) commonly report pain, contributing to physical and emotional distress, and potentially resulting in poor quality of life. This study prospectively identified trends and risk factors in patient-reported pain associated with breast irradiation using the Edmonton Symptom Assessment Scale (ESAS) and a study-specific Skin Symptom Assessment (SSA)., Methods: Before RT and once per week during RT, patients completed the ESAS and SSA. Upon RT completion, patients were contacted via telephone to complete both assessments weekly for 6 weeks, and a final assessment was conducted 1-3 months post-RT. Only data from patients who had completed both assessments before, at least once during, and at least once after RT were included in our analysis., Results: A total of 426 patients provided data for the analysis. Overall acute pain increased significantly at week 1-2 (p < 0.0001), week 5 (p = 0.0011), and at 1-3 months (p < 0.0001) post-RT compared with baseline, and acute breast pain increased significantly at week 1 (p < 0.001) and week 2 (p = 0.0002) post-RT compared with baseline. Previous chemotherapy (adjuvant or neoadjuvant) in mastectomy patients was associated with increased overall pain compared with mastectomy patients without previous chemotherapy (p = 0.017). Younger patients (40-49 or 50-59 years of age) reported more overall pain (p = 0.0001, p = 0.038) and breast pain (p = 0.0003, p = 0.0038) compared with patients ≥ 60 years of age., Conclusions: Patient-reported pain associated with breast irradiation peaked 1 week after RT completion. Our findings provide support for closer monitoring of acute pain associated with breast RT in younger patients.

Purpose: Patients are commonly enrolled into clinical trials. It has been reported that these patients may have better outcomes than those not enrolled into the study. The reasoning from these improvements could be attributable to closer follow-up, better patient adherence, more health aware patients have, or reaction to observation such as the Hawthorne effect., Methods: Three hundred forty-six patients were approached for a prospective skin toxicity study in adjuvant breast cancer radiotherapy (RT) but declined participation between January 2018 and July 2019 (non-trial group). They were retrospectively reviewed and patient, treatment and RT-related characteristics, as well as the occurrence of skin reactions, and the usage of topical treatments were collected. This was compared with a comparison cohort of 349 patients who were enrolled into a previously conducted prospective study (trial group)., Results: More patients in the trial group had conventional RT (CFRT) versus hypofractionated RT (HFRT). Data was further stratified and there was no significant difference in moist desquamation, topical antibiotic usage, dressing application, home care use, topical corticoid steroid use, and oral analgesic use. There was a significantly lower pain score in the group compared with the non-trial group in both HFRT and CFRT (OR = 0.091 and OR = 0.348, p < 0.0001)., Conclusion: Our results demonstrated no differences other than pain between the trial group and non-trial group. Therefore, in this cohort, patients enrolled into an observational trial while undergoing adjuvant breast RT demonstrated similar experiences of skin reactions. There are challenges to assessing differences between these groups, as confounding is likely. Therefore, it is recommended for future studies to additionally assess the impact of study participation on outcomes such as quality of life, quality of care received, and/or anxiety levels.

Background: Breast cancer patients often experience multiple symptoms that negatively affect quality of life (QOL). Patient-reported scores on symptom screening tools are used by health care professionals to manage QOL. We aimed to examine which symptoms from the Edmonton Symptom Assessment Scale (ESAS) were most predictive of overall well-being (QOL) in breast cancer patients over the course of radiotherapy (RT)., Patients and Methods: ESAS results completed before, at the end of, and after RT were obtained from all nonmetastatic breast cancer patients. Univariate and multivariable (backward stepwise selection) linear regression analyses were applied to select the most significant ESAS symptoms or treatment variables related to overall QOL at all 3 time points., Results: A total of 1224 patients were included in the study. Before RT, multivariable analysis identified 5 symptoms that were significantly associated with overall QOL: pain, tiredness, anxiety, depression, and loss of appetite. At the end of RT, pain, tiredness, and anxiety were the most significant predictors of QOL. After RT, 6 symptoms were found to have the strongest correlation with QOL: pain, tiredness, anxiety, depression, loss of appetite, and drowsiness. At each time point, patients with higher scores for the identified significant symptoms were likely to have a worse overall QOL., Conclusion: Of the ESAS symptoms identified as significant predictors of QOL, pain, tiredness, and anxiety correlated with overall well-being at all time points. Special attention should be paid to manage symptoms that are most predictive of overall QOL in order to ensure optimal symptom management in breast cancer patients receiving RT., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: Fatigue or tiredness is one of the most commonly reported symptoms in breast cancer patients treated with radiation therapy (RT). This study aimed to identify characteristics associated with fatigue in breast cancer patients receiving adjuvant RT., Methods: Patients with non-metastatic breast cancer receiving RT at the Odette Cancer Centre from 2011 to 2017 were included in our study if they completed at least one ESAS pre- and post-RT. Information regarding patient, disease and treatment characteristics was retrieved from chart review. To identify variables associated with fatigue scores pre-RT, post-RT and changes in fatigue scores, a univariate and multivariate general linear regression analysis was conducted; p < 0.05 was considered statistically significant., Results: Our study included 1223 female patients (mean age 59 years old) who completed ESAS on average 28 days before, and 142 days after RT. In multivariate analysis, higher baseline fatigue scores were found in women with higher disease stages (p = 0.001), and those who receive locoregional radiation (p < 0.001). No variables were significantly associated with post-RT fatigue scores. While adjuvant chemotherapy and locoregional RT were associated with higher baseline scores in univariate analysis, in multivariate analysis, they were associated with significant reduction in fatigue post-RT (p = 0.01, p = 0.007 respectively)., Conclusions: Fatigue is associated with higher disease stage and receipt of locoregional radiation. While the relationship between anxiety or depressive symptoms and fatigue is well-established, a major gap exists in our understanding of its etiology and treatment; further investigation to address this can better improve patient quality of life., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Cancer patients often present with several concurrent symptoms. There is evidence to suggest that related symptoms can cluster together in stable groups. The present study sought to identify symptom clusters in advanced cancer patients using the Edmonton Symptom Assessment System (ESAS) in a palliative outpatient radiotherapy clinic., Methods: Principal component analysis (PCA), exploratory factor analysis (EFA), and hierarchical cluster analysis (HCA) were used to identify symptom clusters among the 9 ESAS items using ESAS scores from each patient's first visit., Results: PCA identified three symptom clusters (cluster 1: depression, anxiety; cluster 2: nausea, dyspnea, loss of appetite; cluster 3: pain, well-being, tiredness, drowsiness). EFA identified two clusters (cluster 1: tiredness, drowsiness, loss of appetite, well-being, pain, nausea, dyspnea; cluster 2: depression, anxiety). HCA identified three symptom clusters (cluster 1: depression, anxiety, pain, well-being; cluster 2: tiredness, drowsiness, dyspnea; cluster 3: nausea, loss of appetite)., Conclusions: Symptom clusters were identified using three analytical methods. The following items were always in the same cluster: depression and anxiety; nausea and appetite loss; well-being and pain; tiredness and drowsiness. Further research in symptom clusters is necessary to advance our understanding of the complex symptom interactions in advanced cancer patients and to determine the most clinically relevant symptom clusters.

Purpose: To report the changes in quality of life (QoL) after stereotactic ablative radiotherapy (SABR) in patients with liver metastases (LM)., Materials and Methods: A prospective cohort study was undertaken to measure the acute changes in QoL after SABR. Patients with 1-3 treated LM were eligible. Doses of 30-60 Gy in 3-5 fractions were delivered. Prospective QoL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, Core 15 for Palliative Care (EORTC QLQ-C15-PAL) and liver metastases (LM21), at baseline, 1st week and last day of treatment, then 1, 6 and 12 weeks after SABR. The functional living index-emesis (FLIE) was collected at baseline, 1st week, last day and 1 week after treatment. Univariable and multivariable linear mixed modeling were performed as appropriate to assess changes in QoL over time., Results: Sixty patients were included. The most common primary cancer was colorectal (42%). The global health score measured by QLQ-C15-PAL was significantly worse at treatment completion (p = 0.001), 1 week (p = 0.003) and 6 weeks (p = 0.002) after SABR but recovered by 12 weeks (p = 0.124). Nausea and constipation were worse at treatment completion (p < 0.05) but recovered 1 week after while fatigue recovered 6 weeks post-SABR. The majority of patients reported stable QoL at 12 weeks for all domains in the C15-PAL and LM21 questionnaires., Conclusion: SABR offers a non-invasive mean of ablating LM with minimal impact on acute QoL., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Purpose: Radiotherapy-induced nausea and vomiting is a common side effect of radiotherapy. It is well-established that nausea and vomiting have a negative impact on quality of life, but the relative influence of each of symptom is infrequently reported. This study aimed to compare the effects of nausea and vomiting on quality of life in cancer patients receiving palliative radiotherapy., Methods: The Functional Living Index-Emesis (FLIE) is a quality of life questionnaire developed in the chemotherapy-induced nausea and vomiting setting. The FLIE consists of 18 questions, half of which address nausea and half of which address vomiting. Three prospective studies on the efficacy of various anti-emetic medications conducted at our center used the FLIE to assess radiotherapy-induced nausea and vomiting at various time points during and after palliative radiotherapy. FLIE data from these three studies were combined for the present analysis. Univariate and multivariate analyses were conducted to assess the relationships between nausea and vomiting, time of FLIE completion, and patient-reported quality of life., Results: Nausea and vomiting scores both decreased patients' quality of life. Multivariate modeling showed that both symptoms significantly influenced patients' ability to enjoy meals. Nausea was also associated with increased hardship for the patient, while vomiting imposed more difficulty on the patients' loved ones., Conclusions: Nausea and vomiting both significantly influence quality of life. Nausea seems to impact the patient more directly, whereas vomiting affects those closest to the patient.

Background: Nausea and vomiting are commonly experienced by cancer patients, and can be assessed by the Functional Life Index-Emesis (FLIE) instrument which employs a three-day recall period. However, it is unknown whether patients' responses to the FLIE better correlate with the average or the worst symptom severity of the recall period, or the severity of an individual day., Methods: Patients receiving emetogenic radiotherapy for painful bone metastases who were enrolled in one of three trials for anti-emetic medications (ondansetron, aprepitant/granisetron, or palonosetron) completed the FLIE at baseline, and days 3, 5, 7, or 10 during treatment and follow-up. The concordance correlation coefficient (rc) was calculated between FLIE overall nausea and vomiting and daily nausea, vomiting, and quality of life (QoL) using the average responses of the 3-day recall period and with each of the three days' responses., Results: Responses from eighty-nine patients who experienced nausea or vomiting were analysed. The highest concordance for FLIE nausea was with the 3-day average [during treatment: rc =0.698, 95% confidence interval (CI): 0.495, 0.829; follow-up: rc =0.821, 95% CI: 0.711, 0.892]. FLIE vomiting had the highest concordance with worst day vomiting (during treatment, rc =0.310, 95% CI: 0.194, 0.417) or two day-prior vomiting (follow-up, rc =0.902, 95% CI: 0.832, 0.944). FLIE nausea and vomiting had inconsistent concordances with daily assessments of QoL., Conclusions: Responses to the FLIE questionnaire are most representative of average nausea severity. Larger cohorts to validate these findings are warranted to address the lack of power in this present study and to confirm the wording and justification of a three-day recall period for the FLIE.

Purpose: The EORTC QLQ-C30 and the Brief Pain Inventory (BPI) are validated tools for measuring quality of life (QOL) and the impact of pain in patients with advanced cancer. Interpretation of these instrument scores can be challenging and it is difficult to know what numerical changes translate to clinically significant impact in patients' lives. To address this issue, our study sought to establish the minimal clinically important differences (MCID) for these two instruments in a prospective cohort of patients with advanced cancer and painful bone metastases., Methods: Both anchor-based and distribution-based methods were used to estimate the MCID scores from patients enrolled in a randomized phase III trial evaluating two different re-irradiation treatment schedules. For the anchor-based method, the global QOL item from the QLQ-C30 was chosen as the anchor. Spearman correlation coefficients were calculated for all items and only those items with moderate or better correlation (|r| ≥ 0.30) with the anchor were used for subsequent analysis. A 10-point difference in the global QOL score was used to classify improvement and deterioration, and the MCID scores were calculated for each of these categories. These results were compared with scores obtained by the distribution-method, which estimates the MCID purely from the statistical characteristics of the sample population., Results: A total of 375 patients were included in this study with documented pain responses and completed QOL questionnaires at 2 months. 9/14 items in the QLQ-C30 and 6/10 items in the BPI were found to have moderate or better correlation with the anchor. For deterioration, statistically significant MCID scores were found in all items of the QLQ-C30 and BPI. For improvement, statistically significant MCID scores were found in 7/9 items of the QLQ-C30 and 2/6 items of the BPI. The MCID scores for deterioration were uniformly higher than the MCIDs for improvement. Using the distribution-based method, there was good agreement between the 0.5 standard deviation (SD) values and anchor-based scores for deterioration. For improvement, there was less agreement and the anchor-based scores were lower than the 0.5 SD values obtained from the distribution-based method., Conclusion: We present MCID scores for the QLQ-C30 and BPI instruments obtained from a large cohort of patients with advanced cancer undergoing re-irradiation for painful bone metastases. The results from this study were compared to other similar studies which showed larger MCID scores for improvement compared to deterioration. We hypothesize that disease trajectory and patient expectations are important factors in understanding the contrasting results. The results of this study can guide clinicians and researchers in the interpretation of these instruments.

Palliative care aims to improve quality of life (QoL) for patients and families and does so by addressing issues not limited to pathology, but other symptoms that may be debilitating to patient experience and QoL. Despite sexual health being an important aspect of life for many patients, it is often omitted in clinical practice. This review summarizes published primary studies to explore the prevalence and importance of incorporating sexual health in the symptom screening and assessments of palliative patients, to identify current interventions that are implemented to address sexual health issues, and identify the barriers that health care professionals (HCPs) and patients may encounter which may prevent sexual health discussions. A literature review was conducted on Medline and Embase databases using keywords including "cancer", "sexual health", "intimacy", and "palliative care". Eleven papers focusing on the sexual health and intimacy of terminally ill patients in hospice, palliative or terminal care settings were identified for inclusion. Discussions about sexual health, functioning, and intimacy were not common in patient care, despite being a service that both patients and their partners desired. Referrals to sexologists, or discussions with patients and partners about intimacy and sexuality over the course of the disease trajectory were shown to improve QoL as well as alleviate some of the stress of receiving palliative care services. HCPs cited a lack of training, their own life experiences, or discomfort with the topic as barriers to initiating conversations with patients. In conclusion, sexuality and intimacy remain important parts of many people's lives regardless of their health, and should be incorporated into the care of all patients including those in palliative care. There is a need for further research to evaluate different methods or procedures for educating and counselling patients and their partners on sexual health issues. HCPs should have specific training and education in sexual health care to enable them to initiate and direct these discussions.

Background: Patients with bone metastases undergoing palliative radiation therapy (RT) may experience changes in both the functional and symptomatic aspects of quality of life (QOL). The European Organization of Cancer Research and Treatment (EORTC) QOL Questionnaire Core-15 Palliative (QLQ-C15-PAL) is a validated questionnaire employed to assess QOL specifically in palliative patients. Our study aimed to identify single-nucleotide variant (SNV) genetic biomarkers associated with changes in QOL and pain., Methods: Fifty-two patients who received a single 8-Gy RT for painful bone metastases completed the EORTC QOL-C15-PAL questionnaire prior to randomization and at 42-day post RT. Saliva samples obtained at day of RT were sequenced, and SNVs from genes involved in inflammation, radiation response, immune response, DNA damage, or QOL were assessed for association with changes in global QOL or the pain scale items using the Cochran-Armitage trend test. The penalized LASSO method with minimum Bayesian information criterion was used to select a multi-SNV model out of significant SNVs (P<0.005) and to produce prognostic scores for patients that categorized them into risk groups of low, middle, and high., Results: The multivariable model predicting global QOL included 14 SNVs, of which HS1BP3 rs35579164 G:C and ABCA1 rs2230805 C>T had the largest positive and negative effect sizes, respectively (HS1BP3: 8.21, ABCA1: -3.44). The model for the response of QOL pain item included 8 SNVs, of which PLAUR rs4760 A>G and ELAC2rs11545302 had the largest positive and negative effect sizes, respectively (PLAUR: 5.23; ELAC: -3.84). The patients' risk groups were highly predictive of QOL response (P<0.0001) and pain item response (P<0.0001). In logistic regression analysis accounting for baseline factors of gender and primary cancer site, the global QOL risk group predicts pain response after RT [OR: 2.1, 95% confidence interval (CI): 1.2-3.9, P=0.015], but the QOL pain item risk group did not (OR: 0.93; 95% CI: 0.5-1.6, P=0.79). The multi-SNVs model included SNVs from genes involved in metabolism, membrane transport, cell cycle control, ciliary structure, and gene expression regulation., Conclusions: SNVs were significantly associated with changes in global QOL of global domain and pain item in patients with bone metastases. Identification of genetic biomarkers predictive of QOL items may allow patients and health care providers anticipate and better address the needs of the palliative cancer patient population.

The aim of this study was to investigate the extent to which health-related quality of life (HRQOL) parameters have been reported in phase III trials with breast cancer patients (BCPs) who received radiation therapy (RT). We also examine the frequency and correlates of significant HRQOL gains. A systematic review was conducted. When HRQOL was a study endpoint, we extracted data on the instruments used for HRQOL analysis, assessing if there was formal statistical comparison between study groups and the results of such comparisons as reported by the authors of the studies. In result, 182 trials were included. HRQOL was considered as endpoint in 38 (20.8%) of the studies and it was used as primary endpoint in 10.9% of them. Of 22 trials that had a positive primary endpoint, 18 had a significant benefit in HRQOL, in favor of the experimental arm. Of 13 trials that had a negative primary endpoint, there were no differences in HRQOL among the study groups. With respect to HRQOL assessment, statistical methods and definition of timing of evaluation were described in 32 (84.2%) and 36 (94.7%) trials, respectively. In conclusion, HRQOL has been infrequently investigated in trials in BCP who received RT. Statistical methods and timing of evaluation were infrequently described with sufficient detail to be informative.

Purpose: To identify symptom clusters in advanced cancer patients attending a palliative radiotherapy clinic using the Edmonton Symptom Assessment System (ESAS)., Methods: Principal component analysis (PCA), exploratory factor analysis (EFA), and hierarchical cluster analysis (HCA) were used to identify symptom clusters among the nine ESAS items using scores from each patient's first visit., Results: ESAS scores from 182 patients were analyzed. The PCA identified three symptom clusters (cluster 1: depression-anxiety-well-being, cluster 2: pain-tiredness-drowsiness, cluster 3: nausea-dyspnea-loss of appetite). The EFA identified two clusters (cluster 1: tiredness-drowsiness-loss of appetite-well-being-pain-nausea-dyspnea, cluster 2: depression-anxiety). The HCA identified three clusters similar to the PCA with an exception of the loss of appetite item being classified under cluster 1 rather than 3. Two to three symptom clusters were identified using three analytical methods, with similar patterns reported in the literature. Particular groups of items co-occurred consistently across all three analyses: depression and anxiety; nausea and dyspnea; as well as pain, tiredness, and drowsiness., Conclusion: Three similar symptom clusters were identified in our patient population using the PCA and HCA; whereas, the EFA produced two clusters: one physical and one psychological cluster. Given the implications of symptom clusters in the management of quality of life, clinicians should be aware of these clusters to aid in the palliative treatment of patients.

Purpose: Dyspnea is a debilitating symptom commonly experienced by advanced cancer patients that can lead to negative effects on function and quality of life (QOL). The present study aims to determine the relationship between dyspnea and other Edmonton Symptom Assessment System (ESAS) symptoms in palliative cancer patients referred to a radiotherapy clinic., Methods: The presence and severity of dyspnea was measured using the ESAS. All patients that visited a palliative radiotherapy clinic between 1999 to 2002 and 2006 to 2009 and completed the ESAS were included. ESAS scores and other demographic and clinical information were extracted from a prospectively collected database. Statistical tests including chi-squared tests, Spearman correlations, and multivariate analysis were conducted to explore the relationship between dyspnea, other ESAS items, and other demographic factors. Kaplan-Meier overall survival curves were generated based on dyspnea severity., Results: One thousand three hundred forty-four patients were included in the dyspnea analysis; reported moderate or severe dyspnea. Dyspnea severity was significantly associated with eight other ESAS interference severities (p < 0.001). Upon multivariate analysis, greater severity of dyspnea was significantly related to higher ESAS scores for tiredness, nausea, depression, anxious, drowsiness, and poor appetite (p < 0.05). The actuarial median survival time was 6.57 months (95% CI 5.91-7.29 months). There were highly significant differences in overall survival between those with none, mild, and moderate dyspnea (p < 0.0001)., Conclusion: Cancer patients often experience dyspnea along with a multitude of other symptoms. Moderate and severe dyspnea should be assessed and optimally managed to reduce functional and QOL debilitations. As presence of increased dyspnea severity is associated with worse overall survival, interventions should occur at the end of life to reduce symptom burden in palliative patients.

Background: Bone metastases cause pain, suffering and impaired quality of life (QoL). Palliative radiotherapy (RT) and/or chemotherapy are effective methods in controlling pain, reducing analgesics use and improving QoL. This study goal was to investigate the changes in QoL scores among patients who responded to palliative treatment., Methods: A prospective study evaluating the role of radiation therapy in a public academic hospital in São Paulo-Brazil recorded patients' opioid use, pain score, Portuguese version of QLQ-BM22 and QLQ-C30 before and 2 months after radiotherapy. Analgesic use and pain score were used to calculate international pain response category. Overall response was defined as the sum of complete response (CR) and partial response (PR). CR was defined as pain score of 0 with no increase in analgesic intake whereas PR was defined as pain reduction ≥2 without analgesic increase or analgesic reduction in ≥25% without increase in pain at the treated site., Results: From September 2014 to October 2015, 25 patients with bone metastases responded to RT or chemotherapy (1 CR, 24 PR). There were 8 male and 17 female patients. The median age of the 25 patients was 59 (range, 22 to 80) years old. Patient's primary cancer site was breast [11], prostate [5], lung [2], others [7]. For QLQ-BM 22, the mean scores of 4 categories at baseline were: pain site (PS) 39, pain characteristics (PC) 61, function interference (FI) 49 and psycho-social aspects (PA) 57. At 2 month follow up, the scores were PS 27, PC 37, FI 70 and PA 59. Statistical significant improvement (P<0.05) was seen in PS, PC, FI but not PA. In the QLQ-C30, the scores were not statistically different for all categories, except for pain that demonstrated a 33 point decrease in the median pain score domain (66 to 33)., Conclusions: Responders to RT at 2 months presented improvement in BM22 and C30 pain domains, and also improvement in functional interference domain of the BM22 questionnaire.

Background: Pelvic radiation may cause radiation enteritis, which commonly manifests as diarrhea. Radiation to the abdomen or pelvis may also cause radiation-induced nausea and vomiting (RINV) which is often treated with anti-emetics such as serotonin (5-HT3) receptor antagonists (RA). However, a common side effect of these anti-emetic medications is constipation. Both diarrhea and constipation can have a significant impact on patient quality of life (QOL). The objective of this study was to assess the prevalence of diarrhea and constipation in patients receiving pelvic radiation and anti-emetics., Methods: Patients undergoing pelvic radiation between January 2011 and March 2017 at Sunnybrook Odette Cancer Centre were enrolled in three prospective clinical trials studying the efficacy of various anti-emetics for RINV prophylaxis. Patients completed QOL questionnaires which included a single question about severity of constipation at baseline, day 5 and 10 during radiation if applicable, and day 5 and 10 after completion of radiation; severity was measured on a 4-point Likert scale ranging from 1= "not at all" to 4= "very much". Patients also recorded severity of diarrhea throughout baseline, treatment, and 10 days follow-up via daily diaries; responses were qualitative ranging from "no diarrhea" to "severe diarrhea" on a 4-point scale., Results: Fifty-nine patients received pelvic radiation across the three trials. The average constipation score at baseline was 1.69 [standard deviation (SD) 0.93], and increased up to 2.33 (SD 1.03) at day 10 during treatment. Following treatment, the average score decreased to 1.61 (SD 0.80) at day 10 follow-up with the majority of patients reporting no constipation at this time (57.7%). The average diarrhea score at baseline was 1.03 (SD 0.18) and remained stable throughout treatment and follow-up. A vast majority of patients reported no diarrhea after day 10 follow-up (96.4%)., Conclusions: Constipation was more prevalent than diarrhea during radiation treatment and up to day 10 after radiation to the pelvis. Approximately 42% of patients will have constipation on day 10 post radiation. Further research is needed to assess the causes of constipation including analgesics, and the effect on QOL during and shortly after palliative radiation to the pelvis.

Aim: The present study aimed to determine the prognostic survival value of pretreatment health-related quality of life (HRQOL) and changes in HRQOL following whole-brain radiation treatment in patients with brain metastases., Methods: Patients who were treated with whole-brain radiation treatment and completed HRQOL questionnaires were included. Univariate and multivariate Cox proportional hazard models of overall survival (OS) were conducted for overall HRQOL and domain scores., Results & Conclusion: Patients with lower HRQOL at baseline, especially lower physical functioning and motor dysfunction domains, were more likely to have poorer survival. Changes in overall HRQOL and its domains were not significantly related to OS. Pretreatment HRQOL, especially physical functioning and motor dysfunction, has added prognostic value in patients with brain metastases.

Purpose: The purpose of this study was to determine the quality of life (QOL) and symptom burden (SB) among breast cancer patients., Methods: Patients with DCIS, early stage, locally advanced, or metastatic breast cancer completed the Edmonton Symptom Assessment System (ESAS) and the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B). Patients were divided into subsequent cohorts based on their last day of treatment, age at enrollment, radiation, chemotherapy, and hormone therapy., Results: A total of 1513 patients were enrolled. Metastatic patients had a lower QOL and greatest SB compared to all other patient groups. Patients ≤50 years old with early stage or locally advanced breast cancer had a lower QOL and greater SB for fatigue, depression, and anxiety compared to all other age cohorts. Patients with early stage breast cancer who received chemotherapy had a lower QOL and greater SB. Patients taking selective estrogen receptor modulator (SERM) had greater SB for depression and lower QOL compared to those not on SERM. Patients 2-10 years post-treatment had a lower QOL compared to patients ≥10 years post-treatment., Conclusion: Patients ≤50 years old, 2-10 years post-treatment, treated with chemotherapy or SERM had increased SB and decreased QOL. Individualized interventions and programs can be developed to tailor to physical, educational, and psychosocial needs identified across the breast cancer continuum.

Purpose: Previous studies have determined optimal cut points (CPs) for the classification of pain severity as mild, moderate, or severe using only the Brief Pain Inventory (BPI) or the BPI in conjunction with a quality of life (QOL) tool. The purpose of our study was to determine the optimal CPs based on correlation with only QOL outcomes., Methods: We conducted an analysis of 298 patients treated with radiation therapy for painful bone metastases on a phase III randomized trial. Prior to treatment, patients provided their worst pain score on a scale of 0 (no pain) to 10 (worst possible pain), as well as completed the European Organization of Cancer Research and Treatment (EORTC) QOL Questionnaire Bone Metastases module (QLQ-BM22) and the EORTC QOL Questionnaire Core-15 Palliative (QLQ-C15-PAL). Optimal CPs were determined to be those that yielded the largest F ratio for the between category effect on each subscale of the QLQ-BM22 and QLQ-C15-PAL using the multivariate analysis of variance (MANOVA)., Results: The two largest F ratios for Wilk's λ, Pillai's Trace, and Hotelling's Trace were for CPs 5,6 and 5,7. Combining both, the optimal CPs to differentiate between mild, moderate, and severe pain were 5 and 7. Pain scores of 1-5, 6, and 7-10 were classified as mild, moderate, and severe, respectively. Patients with severe pain experienced greater functional interference and poorer QOL when compared to those with mild pain., Conclusion: Our results suggest that, based on the impact of pain on QOL measures, pain scores should be classified as follows: 1-5 as mild pain, 6 as moderate pain, and 7-10 as severe pain. Optimal CPs vary depending on the type of outcome measurement used.

Purpose: The goal of this study was to examine the symptom burden (SB) and quality of life (QOL) in patients with metastatic breast cancer., Methods: Breast cancer patients with metastases were asked to complete the Edmonton Symptom Assessment System (ESAS) and FACT-B questionnaires. Statistical analysis was performed to identify (1) any differences in SB and QOL between patients with bone metastases only and patients with visceral +/- bone metastases and (2) any associations between SB and/or QOL and various clinical factors, including treatment with bisphosphonates, participation in a clinical trial and presence of brain metastases., Results: A total of 174 patients were enrolled. Treatment with bisphosphonates was significantly associated with lower ESAS well-being scores (less symptoms) in patients with bone metastases only. In this same group, receiving treatment prior to diagnosis of metastases was significantly associated with increased fatigue, anxiety and dyspnoea. The presence of brain metastases was associated with higher physical well-being scores (increased QOL). Participation in clinical trials was associated with better QOL., Conclusion: Breast cancer patients with metastases have different SB and QOL in relation to the type of the metastases, treatment interventions and participation in clinical trials.

Purpose: The purpose of this review was to compare the development, characteristics, validity, and reliability of three widely used quality of life (QOL) assessment tools used in colorectal cancer (CRC) patients: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C), the European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Quality of Life Questionnaire Colorectal Cancer Module (QLQ-CR38) and its successor, the QLQ-CR29., Methods: A literature search was conducted using Ovid EMBASE and EMBASE Classic (1996-2015 Week 39), Ovid MEDLINE and OLDMEDLINE (1996 September Week 4 2015), and the Cochrane Central Register of Controlled Trials (up to August 2015) to identify studies that discussed the FACT-C, EORTC QLQ-CR38, and QLQ-CR29 including, but not limited to, their development, characteristics, validity, and reliability., Results: The FACT-C consists of 36 items, presented on a 5-point Likert scale, in four domains of well-being (physical, emotional, social, and functional), and the Colorectal Cancer Subscale (CCS). The physical and social well-being scales showed reasonable internal consistency (Cronbach's alpha coefficient > 60) in all studied populations. The EORTC QLQ-CR38 (38 items) and the QLQ-CR29 (29 items) are implemented in conjunction with the core QLQ-C30 (30 items); all are presented in 4-point Likert scales. Seven scales in the QLQ-CR38 demonstrated good internal consistency (Cronbach's alpha coefficient > 0.70). In the QLQ-CR29, three scales had a Cronbach's alpha coefficient of less than 0.70., Conclusion: The FACT-C, QLQ-CR38, and QLQ-CR29 have been extensively validated. However, analysis of their characteristics, validity, and reliability suggest differing suitability in assessing QOL in specific clinical situations.

Background: To examine the baseline characteristics of patients who underwent different treatments for brain metastases., Methods: Allocated into group A [whole brain radiation therapy (WBRT) alone], or group B [stereotactic radiosurgery (SRS) or neurosurgery with or without WBRT], brain metastases patients with assigned treatment completed the Brain Symptom and Impact Questionnaire (BASIQ). Items of BASIQ were arranged as a symptom score or function score., Results: Lung, breast, melanoma and renal cancer were the most prevalent primary cancer site among the study population, with 91 (53%), 25 (15%), 17 (10%) and 15 (9%) patients, respectively. Baseline BASIQ results were obtained before patients were treated with WBRT, neurosurgery, or SRS. Seventy-six (44%) and 96 patients (56%) were grouped to A and B, respectively. Group A reported lower quality of life (QOL) in all function scores (P<0.0001) and all symptom scores (P values from <0.0001 to 0.005) with the exception of energy (P=0.1)., Conclusions: Baseline QOL in patients assigned WBRT alone was statistically worse as compared to patients assigned SRS, neurosurgery with or without WBRT.

Background: The aim of the present study was to conduct a cross-cultural adaptation (with translation into Brazilian Portuguese) and validation of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Bone Metastases-22 (EORTC QLQ-BM22)., Methods: Ninety-five bone metastasis patients (31 men and 64 women, mean age 58.36±8.90 years) took part in the investigation. The translation guide of the EORTC was used to translate from English into Brazilian Portuguese and adapt the instrument culturally. The reliability and the face, content and construct validities were tested., Results: Internal consistency was estimated using Cronbach's alpha for the total score, pain and functional subscales of the EORTC QLQ-BM22 (0.93, 0.86, 0.90). Reliability was analyzed by Pearson's correlation and intraclass correlation coefficients (ICCs). The correlations were higher than the recommended value of 0.75, which indicated good test-retest reliability. Construct validity was demonstrated by correlation with the questionnaire medical outcome study questionnaire 36-Item Short Form Survey (SF-36). It showed significant correlation between the fields of QLQ-BM22 and the SF-36 (P≤0.001)., Conclusions: The EORTC QLQ-BM22 was translated into Brazilian Portuguese, was culturally adapted and was proven to be reliable, with face, content and construct validity.

Introduction: Mastectomy (MAS) and lumpectomy (LUMP) are the two common local surgical treatments for early breast cancer. There has been a debate whether MAS or LUMP results in better quality of life (QOL). The purpose of this study was to examine the symptom burden (SB) and QOL of both MAS and LUMP patients., Methods: Patients at the Louise Temerty Breast Cancer Centre in Toronto, Canada, were approached to complete two self-administered questionnaires, the Edmonton Symptom Assessment Score (ESAS) and the Functional Assessment of Cancer Therapy-Breast (FACT-B) cancer edition. Additionally, patient demographics were recorded from medical records. Patients were divided into two cohorts depending on their surgical treatment: MAS and LUMP. The QOL and SB, assessed by FACT-B and ESAS, respectively, of MAS and LUMP patients were compared. The analysis was repeated excluding patients with metastases., Results: From January to August 2014, 614 MAS and 801 LUMP patients were accrued. The MAS patients reported a lower QOL in all categories, except social well-being. There was however no statistical difference in ESAS scores for MAS and LUMP patients with non-metastatic breast cancer., Conclusion: This study supports existing literature that SB of MAS and LUMP patients without metastases are similar. QOL of MAS patients including those with metastases was lower than that of LUMP patients.

Purpose: The objective of our study was to determine the optimal cut points for classification of pain scores as mild, moderate, and severe based on interference with function and quality of life (QOL)., Methods: We evaluated 822 patients who completed the Brief Pain Inventory (BPI) and/or the European Organization for Research and Treatment of Cancer (EORTC) QOL Questionnaire Core 30 (QLQ-C30) prior to receiving repeat radiation therapy for previously irradiated painful bone metastases. Optimal cut points for mild, moderate, and severe pain were determined by the MANOVA that yielded the largest F ratio for the between category effect on the seven interference items of BPI and the six functional domains of QOL (physical, role, emotional, cognitive, social functioning, and global QOL) as indicated by Pillai's Trace, Wilk's λ, and Hostelling's Trace F statistics., Results: For BPI and for QOL domains separately, the two largest F ratios for Wilk's λ, Pillai's Trace, and Hotelling's Trace F statistics were from the cut points 4, 8 and 6, 8. When combining both, the optimal cut points were 4, 8 with 1-4 (mild), 5-8 (moderate), and 9-10 (severe). With this classification, the mean scores of all the seven interference items in BPI and the six functional domains were all highly statistically different. Patients with severe pain survived significantly shorter than those with mild and moderate pain (p < 0.0001)., Conclusion: Our analysis supports the classification of pain scores as follows: 1-4 as mild pain, 5-8 as moderate pain, and 9-10 as severe pain. This may facilitate conduct of future clinical trials.

Aims: Quality of life (QOL) is important for advanced cancer patients. Brief questionnaires are advantageous to reduce patient burden. In large clinical trials, statistically significant small changes can be achieved; however, whether such change is clinically relevant is unknown. The purpose of this study was to determine the minimal important differences (MID) of the European Organisation for Research and Treatment of Cancer quality of life core 15 palliative questionnaire (EORTC QLQ-C15-PAL)., Methods: Patients undergoing palliative radiotherapy completed the EORTC QLQ-C15-PAL at baseline and 1 month later. Anchor and distribution-based assessments were employed to determine the MID associated with this instrument. The anchor of overall QOL was used to determine meaningful change., Results: In all, 276 patients were included in MID calculation. Mean age was 65 years and primary lung, breast or prostate cancers were most common. Statistically significant MID for improvement was seen in emotional functioning and pain (20.9 and 15.6, respectively). MID for deterioration required a 20.4, 24.5, 17.1 and 23.0 change in physical functioning, fatigue, pain and appetite loss, respectively, to constitute meaningful change. Distribution-based estimates of MID were closest to the standard error of measurement. MID for brain and bone metastases patients yielded MID larger than previously determined in the incorporation of all patients., Conclusion: Meaningful change in the EORTC QLQ-C15-PAL is important for clinicians to determine the impact of treatment on the QOL of patients and can aid in determining the sample size required for clinical trials. Future studies should investigate MID in subgroups using symptom-specific modules., (© 2013 Wiley Publishing Asia Pty Ltd.)

Background: The purpose was to examine the baseline characteristics, symptoms and quality of life (QOL) in patients who receive different treatments for brain metastases., Methods: Eligible patients were divided and analysed based on their treatment: whole brain radiotherapy (WBRT) alone versus stereotactic radiosurgery (SRS) or neurosurgery with or without WBRT. The Functional Assessment of Cancer Therapy-Brain (FACT-Br) items were grouped according to different domains for summary scores. The domains used for summary scores were physical, social/family, emotional, functional well-being (FWB) and additional concerns., Results: A total of 120 patients were enrolled, with 37 treated with WBRT alone and 83 with SRS or neurosurgery with or without WBRT. Of the 50 baseline FACT-Br items, only five items (I feel ill; I get support from my friends; I worry about dying; I have difficulty expressing my thoughts, I am able to put my thoughts into action) were statistically worse in patients treated with WBRT alone (P<0.05). Patients who received SRS or surgery with or without WBRT had statistically (P<0.05) higher scores for the FWB domain, additional concerns domain, and FACT-G total scores, indicating better QOL., Conclusions: Patients selected for WBRT alone reported statistically different baseline QOL as compared to patients who were treated with SRS or neurosurgery (with or without WBRT).

This review compares the development, characteristics, validity, and reliability of two well-known quality of life (QOL) assessment tools used in patients with gastric cancer: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC QLQ-STO22) and the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga). A literature search was conducted using MEDLINE, EMBASE, and Cochrane CENTRAL (inception to April 2015) to identify studies that discussed the development, characteristics, validity and reliability of the EORTC QLQ-STO22 or the FACT-Ga. The QLQ-STO22 was developed with collaboration with patients, healthcare professionals and literature review and was mainly field tested in European countries. Conversely, items on the FACT-Ga were generated from interviews with patients and healthcare professionals concurrently in North America and Asia. While both modules involve a 7-day recall period and use Likert scales, the QLQ-STO22 and FACT-Ga differ in terms of QOL domain focus, quantity and presentation of items, response options, and scoring. However, both tools show good internal consistency, test-retest reliability, sensitivity to change and construct validity. In addition, both questionnaires have been internationally validated within a large sample of patients undergoing a variety of treatments, thus demonstrating their cross-cultural applicability. The EORTC QLQ-STO22 and FACT-Ga are both valid and reliable tools with unique strengths and weaknesses. Selection between instruments should consider specific patient characteristics and goals of the study.

Introduction: Quality of life (QOL) is an important treatment endpoint in advanced cancer patients with brain metastases. In clinical trials, statistically significant changes can be reached in a large enough population; however, these changes may not be clinically relevant., Objective: The objective of this study was to determine the minimal clinically important difference (MCID) for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire brain module (EORTC QLQ-BN20) in patients with brain metastases., Methods: Patients undergoing radiotherapy for brain metastases completed the EORTC QLQ-BN20 and QLQ-C30/C15-PAL at baseline and 1-month follow-up. MCIDs were calculated for both improvement and deterioration using anchor- and distribution-based approaches. The anchor of overall QOL (as assessed by question 30 or question 15 on the QLQ-C30 and QLQ-C15-PAL, respectively) was used to determine meaningful change., Results: A total of 99 patients were included. The average age was 61 years, and the most common primary cancer sites were the lung and breast. Statistically significant meaningful differences were seen on two scales. A decrease of 6.1 (95 % confidence interval (CI) 0.8 to 11.4) units and 13.8 (0.2 to 27.4) units was required to represent clinically relevant deterioration of seizures and weakness of legs, respectively. Distribution-based MCID estimates tended to be closer to 0.5 SD on the EORTC QLQ-BN20., Conclusion: Understanding MCIDs allows physicians to determine the impact of treatment on patients' QOL and allows for determination of sample sizes for clinical trials. Future studies should be conducted to validate our findings in a larger population of patients with brain metastases.

Background: This study aims to compare the development, characteristics and validity of two widely used tools in the breast cancer population, the EORTC QLQ-BR23 and the FACT-B., Methods: A literature search was conducted using Ovid MEDLINE, OLDMEDLINE, Embase, Embase Classic and the Cochrane Central Register of Controlled Trials to identify relevant studies., Results: Both tools were found to be reliable and valid. The QLQ-BR23 focuses on physical function, whereas the FACT-B emphasizes emotional well-being. Scoring, item format, organization and response options differ between questionnaires., Conclusion: Overall, both questionnaires are effective in assessing breast cancer-specific quality of life. Clear similarities and differences between the two tools exist. Decision-making between the questionnaires should be based on the purpose and design of the study.

Objective: To test the reliability, clinical and psychometric validity of the Brain Symptom and Impact Questionnaire (BASIQ) in patients with brain metastases., Methods: Brain metastases patients were interviewed using the BASIQ, Functional Assessment of Cancer-Brain (FACT-Br) and FACT-General (FACT-G) at baseline, with a follow-up assessment at 1 month., Results: Forty patients had complete one data and the median age was 64 years. Patients with higher KPS, ECOG of 2, primary breast cancer, or >3 brain metastases, scored higher on the symptom scale of the BASIQ. All subscales showed no significant change in patient symptoms from baseline to follow-up., Conclusion: This study supports that the reliability, clinical and psychometric validity of BASIQ to be used in brain metastases patients.

Purpose: We previously demonstrated that 48% of patients with pain at sites of previously irradiated bone metastases benefit from reirradiation. It is unknown whether alleviating pain also improves patient perception of quality of life (QOL)., Patients and Methods: We used the database of a randomized trial comparing radiation treatment dose fractionation schedules to evaluate whether response, determined using the International Consensus Endpoint (ICE) and Brief Pain Inventory pain score (BPI-PS), is associated with patient perception of benefit, as measured using the European Organisation for Resesarch and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and functional interference scale of the BPI (BPI-FI). Evaluable patients completed baseline and 2-month follow-up assessments., Results: Among 850 randomly assigned patients, 528 were evaluable for response using the ICE and 605 using the BPI-PS. Using the ICE, 253 patients experienced a response and 275 did not. Responding patients had superior scores on all items of the BPI-FI (ie, general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) and improved QOL, as determined by scores on the EORTC QLQ-C30 scales of physical, role, emotional and social functioning, global QOL, fatigue, pain, and appetite. Similar results were obtained using the BPI-PS; observed improvements were typically of lesser magnitude., Conclusion: Patients responding to reirradiation of painful bone metastases experience superior QOL scores and less functional interference associated with pain. Patients should be offered re-treatment for painful bone metastases in the hope of reducing pain severity as well as improving QOL and pain interference., (© 2014 by American Society of Clinical Oncology.)

This review aims to compare and contrast the development, characteristics and validity of two widely used quality of life assessment tools in patients with prostate cancers: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25) and Functional Assessment of Chronic Illness Therapy (FACT-P). Both questionnaires present several strengths as well as some limitations in measuring the quality of life of prostate cancer patients. Each tool may be selected accordingly based on study design and needs.

Purpose: This review compares and contrasts the development, validity, and characteristics of two quality of life (QOL) assessment tools used in patients with primary brain cancers: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain Cancer Module (EORTC QLQ-BN20) and the Functional Assessment of Cancer Therapy-Brain (FACT-Br)., Methods: A literature search was conducted using the Cochrane Central Register of Controlled Trials (June 2013), Ovid EMBASE (1947 to 2013, week 27), and Ovid MEDLINE (1946 to July 2013, week 1) to identify studies that discussed the development, characteristics, validity, and reliability of the EORTC QLQ-BN20 or the FACT-Br., Results: The EORTC QLQ-BN20 consists of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = “not at all” to 4 = “very much.” Reliability and validity testing of the QLQ-BN20 revealed a Cronbach’s alpha coefficient that ranged from 0.71 to 0.90. The FACT-Br consists of 23 items that assess general well-being and brain cancer-specific concerns that include concentration, memory, seizures, eyesight, hearing, speech, personality, expression of thoughts, weakness, coordination, and headaches. These items are presented as statements on a scale ranging from 0 = “not applicable” to 4 = “extremely relevant.” The FACT-Br underwent validity as well as test-retest reliability testing with 101 and 46 patients, respectively. Validity testing found low to moderate correlation with the FACT-G questionnaire, while reliability testing for the brain subscale revealed an acceptable correlation coefficient (r = 0.66; p < 0.001)., Conclusions: The QLQ-BN20 and the FACT-Br are both valid and reliable tools that have been used extensively in the primary brain cancer population. Choice between the two tools should consider each instrument’s individual strengths and weaknesses.

Objective: Quality of life (QoL) assessment questionnaires can be burdensome to advanced cancer patients, thus necessitating the need for shorter assessment instruments than traditionally available. We compare three shortened QoL questionnaires in regards to their characteristics, validity, and reliability., Methods: A literature search was conducted to identify studies that employed or discussed three abridged QoL questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Core 15-Palliative Care (EORTC QLQ-C15-PAL), the Functional Assessment of Cancer Therapy-General-7 (FACT-G7), and the Functional Assessment of Chronic Illness Therapy-Palliative Care-14 (FACIT-PAL-14). Articles that discussed questionnaire length, intended use, scoring procedure, and validation were included., Results: The 7-item FACT-G7 is the shortest instrument, whereas the EORTC QLQ-C15-PAL and the FACIT-PAL-14 contain 14 and 15 items, respectively. All three questionnaires have similar recall period, item organization, and subscale components. Designed as core questionnaires, all three maintain content and concurrent validity of their unabridged original questionnaires. Both the EORTC QLQ-C15-PAL and the FACT-G7 demonstrate good internal consistency and reliability, with Cronbach's α ≥0.7 deemed acceptable. The developmental study for the FACIT-PAL-14 was published in 2013 and subsequent validation studies are not yet available., Conclusion: The EORTC QLQ-C15-PAL and the FACT-G7 were found to be reliable and appropriate for assessing health-related QoL issues-the former for palliative cancer patients and the latter for advanced cancer patients receiving chemotherapy. Conceptually, the FACIT-PAL-14 holds promise to cover social and emotional support issues that are not completely addressed by the other two questionnaires; however, further validation is needed.

Objective: To validate the Brain Symptom and Impact Questionnaire (BASIQ) version 1.0 for brain metastases., Methods: Patients with brain metastases and their healthcare professionals (HCPs) assessed the relevance of the BASIQ on a 0-10 scale with 10 as extremely relevant., Results: A total of 52 patients and 20 HCPs participated in this study. In total, 95% of HCPs and 85% of patients found all items relevant. Balance and walking ability were rated relevant by 100% of patients and HCPs. Headache, nausea, energy, memory and ability to do housework were also rated relevant by 100% of HCPs. Over 95% of patients determined the items of ability to do housework, tiredness, energy, vision, memory and putting ideas into words as relevant. There were no items rated below 7 by patients or below 5 by HCPs., Conclusion: This study indicates that BASIQ version 1.0 has valid content items encompassing disease-related symptom and impact on daily living.