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Abstract Background The association between cardiovascular disease and carcinogenesis is bidirectional and well-established. Furthermore, cancer treatment improves overall patient survival, potentially at the cost of incremental and fatal cardiovascular disease (CVD). Aim To evaluate (a) In a real-world cohort, the proportion of patients offered cancer chemotherapy who have antecedent CVD (CVDA); (b) The rates of patient admission with subsequent development of CVD (CVDS) requiring hospital admission post assignment to chemotherapy; (c) The impact of CVDA and CVDS on mortality rates relative to those seen in patients without overt CVD (CVD−) and (d) The time course of mortality in CVD− versus CVDS patients. Methods Retrospective analysis was performed in deidentified linked health data sets. Correlates of mortality were evaluated by Cox proportional hazards evaluation. Relative and absolute time-variability of CVD as a primary cause of death were determined. Results Of the total 17,389 patients, there were 2,159 with CVDA. Over a median follow-up time of 4.6 years, CVDS admissions (n = 8,529) occurred more commonly in the presence of CVDA (70.0% vs. 46.1%, p

ABSTRACT Purpose Cancer can be a source of significant psychological and physical stress. Prolonged stressful stimuli can influence the stress response, mediated by the hypothalamic–pituitary–adrenal (HPA) axis. However, there is limited literature investigating HPA axis function in patients with cancer. Methods A systematic literature review of case–control studies was conducted comparing individuals with and without cancer examining the HPA axis function. Databases (MEDLINE, PubMed, Scopus) were searched from inception to May 2023. Results Seventeen studies met eligibility criteria: nine unstimulated‐cortisol studies and eight reporting the effect of HPA stimulation or suppression. Sixteen studies reported altered levels of HPA function in cancer patients relative to controls, including 13 reporting increased baseline or hyperactive cortisol responses, and four—decreased baseline cortisol or blunted cortisol responses, two of which had patient groups with now known cortisol‐suppressing treatments. HPA dysfunction was observed in patients of both sexes, diverse ages, stages of cancer and cancer treatments. Six papers reported on clinical outcomes with cases experiencing higher levels of fatigue, stress, poor memory, poor well‐being and disturbed sleep. There was significant heterogeneity in methodologies across the studies. Conclusion HPA dysfunction was common in patients with cancer relative to cancer‐free controls. The majority of studies in cancer reported an increased baseline cortisol and increased response to HPA stimulation. There is a need for well‐powered studies using standardised methodology examining the mechanisms of HPA dysregulation and their health outcomes, to enable the development of appropriate tools for the diagnosis and management of HPA dysfunction in cancer.

PURPOSETo guide clinicians and policymakers in three global resource-constrained settings on treating patients with metastatic breast cancer (MBC) when Maximal setting–guideline recommended treatment is unavailable.METHODSA multidisciplinary, multinational panel reviewed existing ASCO guidelines and conducted modified ADAPTE and formal consensus processes.RESULTSFour published resource-agnostic guidelines were adapted for resource-constrained settings; informing two rounds of formal consensus; recommendations received ≥75% agreement.RECOMMENDATIONSClinicians should recommend treatment according to menopausal status, pathological and biomarker features when quality results are available. In first-line, for hormone receptor (HR)–positive MBC, when a non-steroidal aromatase inhibitor and CDK 4/6 inhibitor combination is unavailable, use hormonal therapy alone. For life-threatening disease, use single-agent chemotherapy or surgery for local control. For premenopausal patients, use ovarian suppression or ablation plus hormone therapy in Basic settings. For human epidermal growth factor receptor 2 (HER2)–positive MBC, if trastuzumab, pertuzumab, and chemotherapy are unavailable, use trastuzumab and chemotherapy; if unavailable, use chemotherapy. For HER2-positive, HR-positive MBC, use standard first-line therapy, or endocrine therapy if contraindications. For triple-negative MBC with unknown PD-L1 status, or if PD-L1–positive and immunotherapy unavailable, use single-agent chemotherapy. For germline BRCA1/2 mutation–positive MBC, if poly(ADP-ribose) polymerase inhibitor is unavailable, use hormonal therapy (HR-positive MBC) and chemotherapy (HR-negative MBC). In second-line, for HR-positive MBC, Enhanced setting recommendations depend on prior treatment; for Limited, use tamoxifen or chemotherapy. For HER2-positive MBC, if trastuzumab deruxtecan is unavailable, use trastuzumab emtansine; if unavailable, capecitabine and lapatinib; if unavailable, trastuzumab and/or chemotherapy (hormonal therapy alone for HR-positive MBC).Additional information is available at www.asco.org/resource-stratified-guidelines. It is ASCO's view that healthcare providers and system decision-makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Background: Digital health technology holds the potential to improve cancer care, given the complexity of cancer treatment and care and ongoing nature of survivorship. Advancement of digital health in Australian cancer care requires identification of implementation barriers and enablers, and alignment to strategic priorities driven by needs and opportunities. This study examined diverse views to identify implementation barriers, enablers, and priorities.Methods: People affected by cancer, health professionals, researchers/developers, non-government and government representatives (n = 51) participated in focus groups/interviews discussing barriers, enablers, needs and opportunities for digital health implementation in cancer care. Researchers used thematic analysis to identify critical themes.Results: Issues for implementation of digital health in cancer care were conceptualized across four themes encompassing 16 subthemes. Predominant subthemes were ease of use (98%); user engagement (96%); coordination (90%); access (84%); and cost (77%). Participants called for increased attention to ease of use and user engagement, and emphasized the needs for coordination and collaboration.Conclusions: This study provides rich lived-experience data on enablers, barriers and needs for implementation of digital health in cancer care from perspectives of Australian survivors, health professionals, researchers, developers, non-government and government representatives. This research will inform further development and implementation of digital health in Australian cancer care.

Introduction: Comorbidity is common in people with cancer but there is no agreement on the optimal clinical tool to use to assess for the presence of comorbidity. The aim of this study was to perform a comparative analysis of the commonest comorbidity assessment tools used in clinical cancer care.Methods: Following a systematic literature review, four tools – Adult Comorbidity Evaluation-27 (ACE-27), American Society of Anesthesiology (ASA), Charlson Comorbidity Index (CCI), and Cumulative Illness Rating Scale (CIRS) – were identified as commonly used. Evidence was extracted from original papers following a targeted literature search and summarized under the following categories: tool development, psychometric characteristics, and utility.Results: Three tools (ACE-27, CCI, and CIRS) consisted of comorbidities checklists while ASA evaluated comorbidities according to physical state severity. Only ACE-27 and CCI had data on instrument development. Three (ACE-27, CCI, and CIRS) had high reliability. Although all tools showed criterion and construct validity, only ACE-27, ASA, and CCI had data on content validity. ACE-27 had the highest appropriateness.Conclusion: While CCI is most commonly used, ACE-27 offers the most favorable psychometric and utility characteristics. Future research should focus on the assessment of the relative utility by clinicians of these tools in patients with cancer in clinical settings.

Abstract Background Cardiovascular disease (CVD) is the leading cause of non‐cancer death in cancer survivors, but the risk of CVD varies between cancers. Objectives To synthesise available evidence on patterns and magnitude of CVD mortality risk. Methods A systematic search of Medline (OVID), CINAHL and Scopus databases from 01‐January‐2000 to 16‐July‐2023 of studies of people with cancer, reporting CVD mortality in cancer population compared with a reference population (e.g. general population) as standardised mortality ratios (SMR). Meta‐analysis of SMRs across cancer and CVD types were pooled using a random‐effects model to allow for heterogeneity of the true effect size across studies. Results We identified 136 studies from 16 countries. Sample sizes ranged from 157 to 7,529,481. The majority (n = 98; 72%) were conducted in the United States, followed by Europe (n = 22; 16%). The most common cancers studied were gastrointestinal (n = 34 studies), haematological (n = 31) and breast (n = 29). A total of 876 CVD SMRs were extracted across diverse CVD conditions. Of those, the majority (535; 61%) indicated an increased risk of CVD death (SMR >1), 109 (12%) a lower risk of CVD death (SMR

Abstract Background While there is increasing evidence on the benefits of PROMs in cancer care, the extent of routine collection and use of PROMs in clinical cancer practice across Australia and New Zealand (ANZ) is unknown. This study examined the prevalence and characteristics of PROMs use in routine clinical cancer care in ANZ. Methods An online survey was designed and disseminated via professional societies and organisations using a snowball sampling approach to clinical and health administration professionals managing cancer care in ANZ. A poster advertising the study was also circulated on professional social media networks via LinkedIn and Twitter inviting health professionals from ANZ to participate if they were using or intending to use PROMs in clinical cancer practice. Responders opted into the survey via the survey link. Results From 132 survey views, 91(response rate, 69%) respondents from 56 clinical practices across ANZ agreed to participate in the survey, and of these 55 (n = 55/91, 60%) respondents reported collecting PROMs within their clinical practice. The majority of the respondents were from the State of New South Wales in Australia (n = 21/55, 38%), hospital (n = 35/55, 64%), and a public setting (n = 46/55, 83%). PROMs were collected in all cancer types (n = 21/36, 58%), in all stages of the disease (n = 31/36, 86%), in an adult population (n = 33/36, 92%), applied in English (n = 33/36, 92%), and used to facilitate communication with other reasons (27/36, 75%). A geospatial map analysis provided insights into the variation in PROMs uptake between the two countries and in certain jurisdictions within Australia. This study also highlights the limited resources for PROMs implementation, and a lack of systematic priority driven approach. Conclusion PROM use across Australia and New Zealand seems variable and occurring predominantly in larger metropolitan centres with limited standardisation of approach and implementation. A greater focus on equitable adoption of PROMs in diverse cancer care settings is urgently needed.

BackgroundCarers often assume key roles in cancer care. However, many carers report feeling disempowered and ill‐equipped to support patients. Our group published evidence-based guidelines (the Triadic Oncology [TRIO] Guidelines) to improve oncology clinician engagement with carers and the management of challenging situations involving carers. ObjectiveTo facilitate implementation of the TRIO Guidelines in clinical practice, we aimed to develop, iteratively refine, and conduct user testing of a suite of evidence-based and interactive web-based education modules for oncology clinicians (e-Triadic Oncology [eTRIO]), patients with cancer, and carers (eTRIO for Patients and Carers [eTRIO‐pc]). These were designed to improve carer involvement, communication, and shared decision-making in the cancer management setting. MethodsThe eTRIO education modules were based on extensive research, including systematic reviews, qualitative interviews, and consultation analyses. Guided by the person-based approach, module content and design were reviewed by an expert advisory group comprising academic and clinical experts (n=13) and consumers (n=5); content and design were continuously and iteratively refined. User experience testing (including “think-aloud” interviews and administration of the System Usability Scale [SUS]) of the modules was completed by additional clinicians (n=5), patients (n=3), and carers (n=3). ResultsThe final clinician module comprises 14 sections, requires approximately 1.5 to 2 hours to complete, and covers topics such as carer-inclusive communication and practices; supporting carer needs; and managing carer dominance, anger, and conflicting patient-carer wishes. The usability of the module was rated by 5 clinicians, with a mean SUS score of 75 (SD 5.3), which is interpreted as good. Clinicians often desired information in a concise format, divided into small “snackable” sections that could be easily recommenced if they were interrupted. The carer module features 11 sections; requires approximately 1.5 hours to complete; and includes topics such as the importance of carers, carer roles during consultations, and advocating for the patient. The patient module is an adaptation of the relevant carer module sections, comprising 7 sections and requiring 1 hour to complete. The average SUS score as rated by 6 patients and carers was 78 (SD 16.2), which is interpreted as good. Interactive activities, clinical vignette videos, and reflective learning exercises are incorporated into all modules. Patient and carer consumer advisers advocated for empathetic content and tone throughout their modules, with an easy-to-read and navigable module interface. ConclusionsThe eTRIO suite of modules were rigorously developed using a person-based design methodology to meet the unique information needs and learning requirements of clinicians, patients, and carers, with the goal of improving effective and supportive carer involvement in cancer consultations and cancer care.

Abstract Background Pain is a common, debilitating, and feared symptom, including among cancer survivors. However, large-scale population-based evidence on pain and its impact in cancer survivors is limited. We quantified the prevalence of pain in community-dwelling people with and without cancer, and its relation to physical functioning, psychological distress, and quality of life (QoL). Methods Questionnaire data from participants in the 45 and Up Study (Wave 2, n = 122,398, 2012–2015, mean age = 60.8 years), an Australian population-based cohort study, were linked to cancer registration data to ascertain prior cancer diagnoses. Modified Poisson regression estimated age- and sex-adjusted prevalence ratios (PRs) for bodily pain and pain sufficient to interfere with daily activities (high-impact pain) in people with versus without cancer, for 13 cancer types, overall and according to clinical, personal, and health characteristics. The relation of high-impact pain to physical and mental health outcomes was quantified in people with and without cancer. Results Overall, 34.9% (5,436/15,570) of cancer survivors and 31.3% (32,471/103,604) of participants without cancer reported bodily pain (PR = 1.07 [95% CI = 1.05–1.10]), and 15.9% (2,468/15,550) versus 13.1% (13,573/103,623), respectively, reported high-impact pain (PR = 1.13 [1.09–1.18]). Pain was greater with more recent cancer diagnosis, more advanced disease, and recent cancer treatment. High-impact pain varied by cancer type; compared to cancer-free participants, PRs were: 2.23 (1.71–2.90) for multiple myeloma; 1.87 (1.53–2.29) for lung cancer; 1.06 (0.98–1.16) for breast cancer; 1.05 (0.94–1.17) for colorectal cancer; 1.04 (0.96–1.13) for prostate cancer; and 1.02 (0.92–1.12) for melanoma. Regardless of cancer diagnosis, high-impact pain was strongly related to impaired physical functioning, psychological distress, and reduced QoL. Conclusions Pain is common, interfering with daily life in around one-in-eight older community-dwelling participants. Pain was elevated overall in cancer survivors, particularly for certain cancer types, around diagnosis and treatment, and with advanced disease. However, pain was comparable to population levels for many common cancers, including breast, prostate and colorectal cancer, and melanoma.

Abstract Introduction Data on the impact of specific comorbidities on health outcomes is limited. We compared health status and mental distress between individuals with and without cancer according to comorbidity type. Methods A cross‐sectional analysis using data from the Australian National Health Survey 2017–18 including all respondents aged ≥25 years with and without a history of cancer. The odds of poor health and mental distress were reported according to cancer status, and specific individual and cluster of comorbidities. Results There were 1982 individuals (52% female) with cancer and 12,635 (51% female) without cancer. Individuals with cancer were older, and more likely to have a comorbidity compared with those without cancer. They were more likely to report poor health than those without cancer for each specific comorbidity; except for skin conditions and infectious diseases; with the adjusted odds ratio (aOR) ranging from 1.34 (95% CI = 1.01–1.79) for digestive disorders to 2.93 (95% CI = 1.62–5.29) for blood conditions. The strongest association with poor health (aOR 2.79, 95% CI = 2.27–3.43) and mental distress (aOR 9.01, 95% CI = 7.25–11.20) was observed for those with a comorbid mental illness. Exploratory cluster analysis identified four distinct comorbidity clusters: low comorbidity, musculoskeletal, respiratory and cardiometabolic; cancer survivors in the cardiometabolic cluster had a higher odds of reporting poor health (aOR 3.50, 95% CI = 2.48–4.92) and mental distress (aOR 2.33, 95% CI = 1.53–3.55) than those with a low comorbidity. Conclusions Comorbidities in cancer survivors were common and associated with inferior health status, although the magnitude of the effect varied by comorbidity type. Risk assessment and management of comorbidities should be an important priority for cancer care and research.

The current management of patients with multimorbidity is suboptimal, with either a single-disease approach to care or treatment guideline adaptations that result in poor adherence due to their complexity. Although this has resulted in calls for more holistic and personalized approaches to prescribing, progress toward these goals has remained slow. With the rapid advancement of machine learning (ML) methods, promising approaches now also exist to accelerate the advance of precision medicine in multimorbidity. These include analyzing disease comorbidity networks, using knowledge graphs that integrate knowledge from different medical domains, and applying network analysis and graph ML. Multimorbidity disease networks have been used to improve disease diagnosis, treatment recommendations, and patient prognosis. Knowledge graphs that combine different medical entities connected by multiple relationship types integrate data from different sources, allowing for complex interactions and creating a continuous flow of information. Network analysis and graph ML can then extract the topology and structure of networks and reveal hidden properties, including disease phenotypes, network hubs, and pathways; predict drugs for repurposing; and determine safe and more holistic treatments. In this article, we describe the basic concepts of creating bipartite and unipartite disease and patient networks and review the use of knowledge graphs, graph algorithms, graph embedding methods, and graph ML within the context of multimorbidity. Specifically, we provide an overview of the application of graph theory for studying multimorbidity, the methods employed to extract knowledge from graphs, and examples of the application of disease networks for determining the structure and pathways of multimorbidity, identifying disease phenotypes, predicting health outcomes, and selecting safe and effective treatments. In today’s modern data-hungry, ML-focused world, such network-based techniques are likely to be at the forefront of developing robust clinical decision support tools for safer and more holistic approaches to treating older patients with multimorbidity.

BackgroundSelf-management (SM) plays an important role in supporting patients’ adaptation to and management of the symptoms of chronic diseases. Cancer is a chronic disease that requires patients to have responsibility in management. Digital technology has the potential to enhance SM support, but there is little data on what SM skills are most commonly supported by digital technology. ObjectiveThis review aimed to examine the SM core skills that were enabled and supported by digital interventions in people with cancer and identify any predictors of the effect of digital health intervention on SM core skills. MethodsThree electronic databases (MEDLINE, Scopus, and CINAHL) were searched for papers, published from January 2010 to February 2022, that reported randomized controlled trials (RCTs) involving patients with cancer or survivors of cancer where a digital technology intervention was evaluated and change in 1 or more SM core skills was a measured outcome. ResultsThis systematic review resulted in 12 studies that were eligible to identify which SM core skills were enabled and supported by digital intervention. The total number of participants in the 12 studies was 2627. The most common SM core skills targeted by interventions were decision-making, goal setting, and partnering with health professionals. A total of 8 (67%) out of 12 RCTs demonstrated statistically significant improvement in outcomes including self-efficacy, survivorship care knowledge and attitude, quality of life, increased knowledge of treatment, and emotional and social functioning. A total of 5 (62%) out of 8 positive RCTs used theoretical considerations in their study design; whereas in 1 (25%) out of 4 negative RCTs, theoretical considerations were used. In 3 studies, some factors were identified that were associated with the development of SM core skills, which included younger age (regression coefficient [RC]=–0.06, 95% CI –0.10 to –0.02; P=.002), computer literacy (RC=–0.20, 95% CI –0.37 to –0.03; P=.02), completing cancer treatment (Cohen d=0.31), male sex (SD 0.34 in social functioning; P=.009), higher education (SD 0.19 in social functioning; P=.04), and being a recipient of chemotherapy (SD 0.36 in depression; P=.008). In all 3 studies, there were no shared identical factors that supported the development of SM core skills, whereby each study had a unique set of factors that supported the development of SM core skills. ConclusionsDigital technology for patients with cancer appears to improve SM core skills including decision-making, goal setting, and partnering with health care partners. This effect is greater in people who are younger, male, educated, highly computer literate, completing cancer treatment, or a recipient of chemotherapy. Future research should focus on targeting multiple SM core skills and identifying predictors of the effect of digital technology intervention. Trial RegistrationPROSPERO CRD42021221922; https://tinyurl.com/mrx3pfax

Abstract Background Women living with metastatic breast cancer (MBC) are at risk of significantly impaired quality of life (QOL), symptom burden, distress and fear of progression, and unmet needs, yet they face barriers to accessing evidence-based psychosocial treatments. Our group therefore developed Finding My Way-Advanced (FMW-A), a web-based self-guided psychosocial program for women with MBC. This study aims to assess its efficacy in improving mental and other QOL domains, distress, fear of progression, unmet needs, and health service utilisation. Methods The multi-site randomised controlled trial (RCT) will enrol 370 Australian participants. Eligible participants are adult (18 years +) women diagnosed with MBC, with a life expectancy of 6 months or more, with sufficient English-language literacy to provide informed consent. Participants will be identified, screened and referred from one of 10 Australian sites, or via self-referral in response to advertisements. Participants complete four online questionnaires: prior to accessing their program (‘baseline’), 6 weeks later (‘post-intervention’), then 3 months and 6 months post-intervention. Consenting participants will be randomised to either FMW-A (intervention), or Breast Cancer Network Australia’s (BCNA) online/app resource My Journey (minimal intervention attention-control). This is a single-blind study, with randomisation computer-generated and stratified by site. FMW-A is a 6-module program addressing some of the most common issues experienced by women with MBC, with BCNA control resources integrated within the ‘resources’ section. All modules are immediately accessible, with an additional booster module released 10 weeks later. The primary outcome is mental QOL; statistical criteria for superiority is defined as a 4-point difference between groups at post-treatment. Secondary outcomes include other QOL domains, distress, fear of progression, health service use, intervention adherence, and user satisfaction. Discussion This will be the first adequately powered RCT of a self-directed online intervention for women with MBC. If efficacious, FMW-A will help address two national key priorities for management of MBC – enhancing QOL and reducing symptom burden. FMW-A has the potential to address unmet needs and overcome access barriers for this overlooked population, while reducing health system burden. Trial registration The study was registered prospectively with the ANZCTR on 29/10/2021. Trial ID ACTRN12621001482853p. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382714&isReview=true

Perspectives of cancer survivors, caregivers, and social workers as key stakeholders on the clinical management of financial toxicity (FT) are critical to identify opportunities for better FT management. Semi-structured interviews (cancer survivors, caregivers) and a focus group (social workers) were undertaken using purposive sampling at a quaternary public hospital in Australia. People with any cancer diagnosis attending the hospital were eligible. Data were analysed using inductive-deductive content analysis techniques. Twenty-two stakeholders (n = 10 cancer survivors of mixed-cancer types, n = 5 caregivers, and n = 7 social workers) participated. Key findings included: (i) genuine concern for FT of cancer survivors and caregivers shown through practical support by health care and social workers; (ii) need for clarity of role and services; (iii) importance of timely information flow; and (iv) proactive navigation as a priority. While cancer survivors and caregivers received financial assistance and support from the hospital, the lack of synchronised, shared understanding of roles and services in relation to finance between cancer survivors, caregivers, and health professionals undermined the effectiveness and consistency of these services. A proactive approach to anticipate cancer survivors’ and caregivers’ needs is recommended. Future research may develop and evaluate initiatives to manage cancer survivors and families FT experiences and outcomes.

Abstract Background To report a case of bilateral intermediate uveitis without cystoid macular edema secondary to paclitaxel therapy, and its successful management with oral corticosteroids. Case presentation A 66-year-old female developed bilateral intermediate uveitis with reduced best corrected visual acuity to 20/40 right and 20/200 left, following 12 cycles of paclitaxel therapy for breast carcinoma. Optical coherence tomography demonstrated no cystoid macular edema in either eye, and fundus fluorescein angiography showed localized retinal vascular leakage. Resolution of uveitis and improvement of visual acuity followed treatment with oral prednisolone for two months. Fourteen months after presentation, right and left visual acuities had returned to 20/32 and 20/40, respectively, and there was no recurrence of the uveitis. Conclusions This is the first reported case of bilateral intermediate uveitis in a patient treated with paclitaxel. Drug-induced uveitis should be considered in patients with visual symptoms in the setting of taxane chemotherapy, and oral corticosteroids are a safe and effective treatment.

Electronic patient-reported outcome (ePRO) applications promise great added value for improving symptom management and health-related quality of life. The aim of this narrative review is to describe the collection and use of ePROs for cancer survivorship care, with an emphasis on ePRO-symptom monitoring. It offers many different perspectives from research settings, while current implementation in routine care is ongoing. ePRO collection optimizes survivorship care by providing insight into the patients’ well-being and prioritizing their unmet needs during the whole trajectory from diagnosis to end-of-life. ePRO-symptom monitoring can contribute to timely health risk detection and subsequently allow earlier intervention. Detection is optimized by automatically generated alerts that vary from simple to complex and multilayered. Using ePRO-symptoms during in-hospital consultation enhances the patients’ conversation with the health care provider before making informed decisions about treatments, other interventions, or self-management. ePRO(-symptoms) entail specific implementation issues and complementary ethics considerations. The latter is due to privacy concerns, digital divide, and scarcity of adequately representative data for particular groups of patients.

Abstract Purpose To identify subgroups of female breast cancer patients with distinct self-reported employment interference (EI) profiles and determine which demographic, clinical, and symptom characteristics, and quality of life outcomes were associated with subgroup membership. Methods Women with breast cancer (n = 385) were assessed for changes in EI over ten times, from prior to, through 12 months after breast cancer surgery. Latent profile analysis (LPA) was used to identify subgroups of patients with distinct EI profiles. Results Three distinct EI profiles (i.e., None – 26.2% (n = 101), Low – 42.6% (n = 164), High – 31.2% (n = 120)) were identified. Compared to the None and Low groups, patients in the High group were more likely to be younger. Higher proportions in the High group were non-White, pre-menopausal prior to surgery, had more advanced stage disease, had received an axillary lymph node dissection, had received neoadjuvant chemotherapy, had received adjuvant chemotherapy, and had a re-excision or mastectomy on the affected breast within 6 months after surgery. In addition, these patients had lower quality of life scores. Compared to the None group, the High group had higher levels of trait and state anxiety, depressive symptoms, fatigue and sleep disturbance and lower levels of cognitive function. Conclusions This study provides new knowledge regarding EI profiles among women in the year following breast cancer surgery. The non-modifiable risk factors (e.g., younger age, being non-White, having more advanced stage disease) can inform current screening procedures. The potentially modifiable risk factors can be used to develop interventions to improve employment outcomes of breast cancer patients.

Abstract Background Opportunities for cancer survivors’ employment can both reflect and perpetuate health inequities, as employment is an important social determinant of health. Socio‐economic and geographic disadvantage is associated with greater difficulty finding work, but little is known about work needs of Australian cancer survivors living with disadvantage. Objective This study examined survivor and health‐care professional (HCP) perspectives on barriers experienced by Australian cancer survivors experiencing disadvantage when attempting to remain at or return to work. Method Focus groups and individual interviews were held with cancer survivors (N = 15) and oncology and primary HCPs (N = 41), focusing on communities at risk of disadvantage. Participants were asked about employment barriers and facilitators in general and in the context of disadvantage. Themes were identified using framework analysis. Results Geographic and socio‐economic disadvantage resulted in specific individual‐ and system‐level barriers. These related to distance from treatment and support services and limited availability and suitability of work for survivors living with geographic disadvantage, and limited availability, security, and flexibility of work and previous unemployment for survivors living with socio‐economic disadvantage. Identified needs included system‐level changes such as public and workplace‐level education, legislative and policy changes, and better access to resources. Conclusions Cancer survivors living with disadvantage experience limited access to flexible employment opportunities and resources, further perpetuating their disadvantage. Promotion of health equity for cancer survivors living with disadvantage requires systemic changes to support attempts to remain at/return to work. Patient or public contribution This study included cancer survivors and HCPs as investigators, authors and participants.

Abstract While many studies have evaluated the relationship between BMI and breast cancer outcomes, it is unclear whether this relationship is consistent between early breast cancer (BC) and advanced BC. The study included 5099 patients with HER2 positive early BC (EBC) and 3496 with HER2 positive advanced BC (ABC). In the EBC cohort, higher BMI was associated with worse overall survival (OS) (HR [95% CI]: overweight = 1.30 [1.13–1.51]; obese = 1.37 [1.14–1.64], P =

Abstract Background Improved survival means that cancer is increasingly becoming a chronic disease. Understanding and improving functional outcomes are critical to optimising survivorship. We quantified physical and mental health-related outcomes in people with versus without cancer, according to cancer type. Methods Questionnaire data from an Australian population-based cohort study (45 and Up Study (n = 267,153)) were linked to cancer registration data to ascertain cancer diagnoses up to enrolment. Modified Poisson regression estimated age- and sex-adjusted prevalence ratios (PRs) for adverse person-centred outcomes—severe physical functional limitations (disability), moderate/high psychological distress and fair/poor quality of life (QoL)—in participants with versus without cancer, for 13 cancer types. Results Compared to participants without cancer (n = 244,000), cancer survivors (n = 22,505) had greater disability (20.6% versus 12.6%, respectively, PR = 1.28, 95%CI = (1.25–1.32)), psychological (22.2% versus 23.5%, 1.05 (1.02–1.08)) and poor/fair QoL (15.2% versus 10.2%; 1.28 (1.24–1.32)). The outcomes varied by cancer type, being worse for multiple myeloma (PRs versus participants without cancer for disability 3.10, 2.56–3.77; distress 1.53, 1.20–1.96; poor/fair QoL 2.40, 1.87–3.07), lung cancer (disability 2.81, 2.50–3.15; distress 1.67, 1.46–1.92; poor/fair QoL 2.53, 2.21–2.91) and non-Hodgkin’s lymphoma (disability 1.56, 1.37–1.78; distress 1.20, 1.05–1.36; poor/fair QoL 1.66, 1.44–1.92) and closer to those in people without cancer for breast cancer (disability 1.23, 1.16–1.32; distress 0.95, 0.90–1.01; poor/fair QoL 1.15, 1.05–1.25), prostate cancer (disability 1.11, 1.04–1.19; distress 1.09, 1.02–1.15; poor/fair QoL 1.15, 1.08–1.23) and melanoma (disability 1.02, 0.94–1.10; distress 0.96, 0.89–1.03; poor/fair QoL 0.92, 0.83–1.01). Outcomes were worse with recent diagnosis and treatment and advanced stage. Physical disability in cancer survivors was greater in all population subgroups examined and was a major contributor to adverse distress and QoL outcomes. Conclusions Physical disability, distress and reduced QoL are common after cancer and vary according to cancer type suggesting priority areas for research, and care and support.

Abstract Background Nivolumab improves disease control and survival in advanced NSCLC in patients with good performance status (PS), but there is limited data on its efficacy in patients with poor PS. Aim Primary objective of the study was to evaluate the efficacy and safety of nivolumab and examine the influence of PS on outcomes. Methods and Results Retrospective analysis of patients treated with single‐agent nivolumab for advanced NSCLC at a single institution was performed. Sixty‐six patients treated with nivolumab were identified (33 male) with a median age of 68.5 years. Fifty‐six (85%) patients were current or former smokers and 17 (26%) had brain metastasis. All patients had received prior chemotherapy, 39 (59%) patients received one and 27 (41%) had ≥2 prior lines of therapy. Median overall survival (OS) was 7.1 months (95%CI 3.61–11.3) in the overall study population. OS of patients with PS ≥2 at the start of treatment was 3.04 months (95%CI 1.64–7.36) as compared to 10.23 months (95%CI 7.06–18.9) with PS ≤1. The overall response rate was 7% (four patients had a partial response), 23 (40%) patients had stable disease; the overall disease control rate (partial response and stable disease) was 47%. Twenty‐six (40%) patients had PS ≥2 at the start of treatment and 2 (8%) of these patients developed a partial response, 4 (15%) had stable disease; the overall disease control rate was 23%. Fourteen (58%) patients with PS ≥2 had disease progression at the time of first disease response evaluation. In the overall population, 20% of patients experienced grade ≥3 treatment‐related adverse events (TRAEs), most commonly pneumonitis, hepatitis, and colitis. Fourteen TRAEs led to treatment discontinuation, 9 (23%) adverse events (AEs) in patients with PS ≤1 and 5 (19%) with PS ≥2. Fourteen (21%) patients died within 30 days of the last nivolumab treatment. Conclusion There was no significant difference in toxicity leading to treatment discontinuation between the poor and good PS groups, but survival was shorter with poorer PS. PS appears to be an important prognostic factor and remains a relevant discriminator in the selection of treatment with immunotherapy for lung cancer.

Abstract Background Healthy Living after Cancer (HLaC) was a national dissemination and implementation study of an evidence-based lifestyle intervention for cancer survivors. The program was imbedded into existing telephone cancer information and support services delivered by Australian state-based Cancer Councils (CC). We report here the reach, effectiveness, adoption, implementation, and maintenance of the program. Methods In this phase IV study (single-group, pre-post design) participants - survivors of any type of cancer, following treatment with curative intent - received up to 12 nurse/allied health professional-led telephone health coaching calls over 6 months. Intervention delivery was grounded in motivational interviewing, with emphasis on evidence-based behaviour change strategies. Using the RE-AIM evaluation framework, primary outcomes were reach, indicators of program adoption, implementation, costs and maintenance. Secondary (effectiveness) outcomes were participant-reported anthropometric, behavioural and psychosocial variables including: weight; physical activity; dietary intake; quality-of-life; treatment side-effects; distress; and fear of cancer recurrence and participant satisfaction. Changes were evaluated using linear mixed models, including terms for timepoint (0/6 months), strata (Cancer Council), and timepoint x strata. Results Four of 5 CCs approached participated in the study. In total, 1183 cancer survivors were referred (mostly via calls to the Cancer Council telephone information service). Of these, 90.4% were eligible and 88.7% (n = 791) of those eligible consented to participate. Retention rate was 63.4%. Participants were mostly female (88%), aged 57 years and were overweight (BMI = 28.8 ± 6.5 kg/m2). Improvements in all participant-reported outcomes (standardised effect sizes of 0.1 to 0.6) were observed (p

BackgroundCancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. ObjectiveThis study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. MethodsTo an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. ResultsThe website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. ConclusionsReplication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 International Registered Report Identifier (IRRID)DERR1-10.2196/31976

Abstract Background Chemotherapy can cause premature menopause which may result in adverse effects such as fertility loss, osteoporosis, cardiovascular disease and menopausal symptoms. It is thus very important that women are provided with accurate information regarding their risk of premature menopause as a consequence of proposed chemotherapy. Unfortunately, at present there are no reliable tools which can be applied in clinical practice to estimate the risk of premature menopause in women undergoing chemotherapy, beyond age of the patient and form of chemotherapy utilized. Aim This was a pilot study to determine whether AMH levels pre and during chemotherapy are able to predict for chemotherapy induced menopause, and to assess quality of life and menopausal symptoms. Methods and results Premenopausal women between 18 to 45 who were planned to undergo gonadotoxic chemotherapy with curative intent for either breast cancer or haematologic malignancy were recruited from a single centre. AMH, FSH, LH and oestradiol levels were recorded prior to commencement of therapy, during and following completion of chemotherapy. Menstrual status, menopausal symptoms and quality of life data were collected at baseline and during follow‐up. Twenty two women were recruited. The baseline AMH was higher in women who regained menses post‐chemotherapy (median 23.1 vs 9.9 pM (P = .06). Menopausal symptoms were significantly higher at 1 year post diagnosis than at baseline however quality of life was similar. Conclusion AMH may be useful for predicting chemotherapy induced menopause. Further research is still required to determine the place of such testing for patient counselling and management.

Abstract Background/aim Cardiotoxicity is a potential complication of anticancer therapy. While guidelines have been developed to assist practitioners, an effective, evidence based clinical pathway for the treatment of cardiotoxicity has not yet been developed. The aim of this study was to describe the journey of patients who developed cardiotoxicity through the healthcare system in order to establish baseline data to inform the development and implementation of a patient-centred, evidence-based clinical pathway. Methods Mixed-methods design with quantitative and qualitative components using process mapping at 3 large medical centres in 2 states between 2010 and 2015. Results Fifty (50) confirmed cases of cardiotoxicity were reviewed (39 medical record reviews, 7 medical record review and interviews and 4 internview only). The mean age at cancer diagnosis of this group was 53.3 years (range 6–89 years); 50% female; 30% breast cancer, 23% non-Hodgkin’s lymphoma; mean chemotherapy cycles 5.2 (median 6; range 1–18); 49 (89%) presented to chemotherapy with pre-existing cardiovascular risk factors; 39 (85%) had at least one modifiable risk factor and 11 (24%) had more than 4; 44 (96%) were diagnosed by echocardiogram and 27 (57%) were referred to a cardiologist (only 7 (15%) before chemotherapy). Post chemotherapy, 22 (48%) patients were referred to a multidisciplinary heart failure clinic; 8 (17%) to cardiac rehabilitation; 1 (2%) to cancer survivorship clinic and 10 (22%) to a palliative care service. There were 16 (34%) deaths during the timeframe of the study; 4 (25%) cardiac-related, 6 (38%) cancer-related, 4 (25%) due to sepsis and 2 (12%) other causes not recorded. The main concerns participants raised during the interviews were cancer professionals not discussing the potential for cardiotoxicity with them prior to treatment, nor risk modification strategies; a need for health education, particularly regarding risks for developing heart failure related to cancer treatment; and a lack of collaboration between oncologists and cardiologists. Conclusions Our results demonstrate that the clinical management of cancer patients with cardiotoxicity was variable and fragmented and not patient centered. This audit establishes practice gaps that can be addressed through the design of an evidence-based clinical pathway for cancer patients with, or at risk, of cardiotoxicity.

Objective Informal family caregivers play a crucial role in cancer care. Effective caregiver involvement in cancer care can improve both patient and caregiver outcomes. Despite this, interventions improving the caregiver involvement are sparse. This protocol describes a randomised controlled trial evaluating the combined effectiveness of novel online caregiver communication education modules for: (1) oncology clinicians (eTRIO) and (2) patients with cancer and caregivers (eTRIO-pc).Methods and analysis Thirty medical/radiation/surgical oncology or haematology doctors and nurses will be randomly allocated to either intervention (eTRIO) or control (an Australian State Government Health website on caregivers) education conditions. Following completion of education, each clinician will recruit nine patient–caregiver pairs, who will be allocated to the same condition as their recruiting clinician. Eligibility includes any new adult patient diagnosed with any type/stage cancer attending consultations with a caregiver. Approximately 270 patient–caregiver pairs will be recruited. The primary outcome is caregiver self-efficacy in triadic (clinician–patient–caregiver) communication. Patient and clinician self-efficacy in triadic communication are secondary outcomes. Additional secondary outcomes for clinicians include preferences for caregiver involvement, perceived module usability/acceptability, analysis of module use, satisfaction with the module, knowledge of strategies and feedback interviews. Secondary outcomes for caregivers and patients include preferences for caregiver involvement, satisfaction with clinician communication, distress, quality of life, healthcare expenditure, perceived module usability/acceptability and analysis of module use. A subset of patients and caregivers will complete feedback interviews. Secondary outcomes for caregivers include preparedness for caregiving, patient–caregiver communication and caring experience. Assessments will be conducted at baseline, and 1 week, 12 weeks and 26 weeks post-intervention.Ethics and dissemination Ethical approval has been received by the Sydney Local Health District Human Research Ethics Committee (REGIS project ID number: 2019/PID09787), with site-specific approval from each recruitment site. Protocol V.7 (dated 1 September 2020) is currently approved and reported in this manuscript. Findings will be disseminated via presentations and peer-reviewed publications. Engagement with clinicians, media, government, consumers and peak cancer groups will facilitate widespread dissemination and long-term availability of the educational modules.Trial registration number ACTRN12619001507178.

Introduction: Beta-blockers (BB) are commonly used to manage cardiovascular disease and may have benefits in controlling complications of anti-HER2 therapies. This study aimed to evaluate the association of pre-existing BB use with survival outcomes in patients initiating anti-HER2 therapy for advanced breast cancer (ABC).Materials and Methods: Data from clinical trials EMILIA, TH3RESA, MARIANNE, and CLEOPATRA was pooled. Cox proportional analysis was used to assess the association between pre-existing BB use with survival outcomes in patients initiating anti-HER2 therapies.Results: Of the 2,777 patients with HER2 positive ABC, 266 were using a BB at the time of anti-HER2 therapy initiation. BB use was associated with worse overall survival (OS) (adjusted HR = 1.27, 95% CI: 1.04–1.55). Sensitivity analysis in patients with pre-existing cardiovascular disease (CVD) also indicated that BB use was associated with worse OS (1.29, 1.02–1.63).Conclusion: In large high-quality data, BB use at the time of anti-HER2 therapy initiation for ABC was independently associated with worse OS, regardless of CVD status. The finding is contrary to pre-study hypotheses and findings in other BC subtypes. Future research should aim to gain a deeper understanding of the effects of BBs on specific BC subtypes, cancer types, and cancer treatments.

Abstract Background Cardiotoxicity from anticancer therapy affects heart function and structure. Cardiotoxicity can also lead to accelerated development of chronic diseases, especially in the presence of risk factors. Methods This study aimed to develop and pilot a combined cardiovascular disease and cardiotoxicity risk assessment questionnaire to quantify the potential extent of risk factors in breast cancer patients prior to treatment. The questionnaire underwent content and face validity evaluation by an expert panel followed by pilot testing in a sample of breast cancer patients (n = 36). Questionnaires were self-administered while attending chemotherapy clinic, in the presence of a research assistant. Results Mean age of participants was 54.8 years (range 36–72 years). Participants reported CVD risk factors including diabetes 2.8%, hypertension 19.8%, hypercholesterolaemia 11% and sleep apnoea 5%. Lifestyle risk factors, included not eating the recommended serves of vegetables (100%) or fruit (78%) per day; smoking (13%) and regularly consuming alcohol (75%). Twenty five percent reported being physically inactive, 61%, overweight or obese, 24%, little or no social support and 30% recorded high to very high psychological distress. Participants were highly (75%) reluctant to undertake lifestyle changes; i.e. changing alcohol consumption; dietary habits; good emotional/mental health strategies; improving physical activity; quitting smoking; learning about heart-health and weight loss. Conclusion This study is an important step towards prevention and management of treatment-associated cardiotoxicity after breast cancer diagnosis. We recommend that our questionnaire is providing important data that should be included in cancer registries so that researchers can establish the relationship between CVD risk profile and cardiotoxicity outcomes and that this study revealed important teaching opportunities that could be used to examine the impact on health literacy and help patients better understand the consequences of cancer treatment.

Background The development of comorbidities has become increasingly relevant with longer-term cancer survival. Objective To assess the pattern of comorbidities among Australian women with breast cancer treated with tamoxifen or an aromatase inhibitor. Design Retrospective cohort study using Pharmaceutical Benefits Scheme (PBS) data (10% sample) from January 2003 to December 2014. Dispensing claims data were used to identify comorbidities and classified with the Rx-Risk-V model. The breast cancer cohort had tamoxifen or an aromatase inhibitor dispensed between 2004 and 2011 with no switching between types of endocrine therapy. Comparisons were made between the breast cancer cohort and specific control groups (age- and sex-matched at 1:10 ratio without any dispensing of anti-neoplastic agents during the study period) for the development of five individual comorbidities over time using Cox regression models. Results Women treated with tamoxifen had a higher incidence of cardiovascular conditions, diabetes, and pain or pain-inflammation, but a lower incidence of hyperlipidaemia compared with non-cancer control groups, as indicated by PBS data. Women treated with aromatase inhibitors were more likely to develop cardiovascular conditions, osteoporosis, and pain or pain-inflammation compared with non-cancer control groups. The risks of hyperlipidaemia and osteoporosis were significantly lower among tamoxifen users compared with aromatase inhibitor users. Conclusions Women with hormone-dependent breast cancer treated with an endocrine therapy had a higher risk of developing specified comorbid conditions than women without cancer, with different comorbidity profiles for those on tamoxifen versus aromatase inhibitors. Further research into the causes and mechanism of development and management of comorbidities after cancer is needed.