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Purpose: Electronic patient-reported outcomes (ePROs) are increasingly being used for symptom monitoring during routine cancer care, but have rarely been evaluated in diverse patient populations. We assessed ePRO user experiences and perceived value among Black and White cancer patients., Methods: We recruited 30 Black and 49 White bladder and prostate cancer patients from a single institution. Participants reported symptoms using either a web-based or automated telephone interface over 3 months and completed satisfaction surveys and qualitative interviews focused on user experiences and value. Using a narrative mixed methods approach, we evaluated overall and race-specific differences in ePRO user experiences and perceived value., Results: Most participants selected the web-based system, but Blacks were more likely to use the automated telephone-based system than Whites. In satisfaction surveys, Whites more commonly reported ease in understanding and reporting symptoms compared with Blacks. Blacks more often reported that the ePRO system was helpful in facilitating symptom-related discussions with clinicians. During interviews, Blacks described how the ePRO helped them recognize symptoms, while Whites found value in better understanding and tracking symptoms longitudinally. Blacks also expressed preferences for paper-based ePRO options due to perceived ease in better understanding of symptom items., Conclusion: Electronic patient-reported outcomes are perceived as valuable for variable reasons by Black and White cancer populations, with greater perceived value for communicating with clinicians reported among Blacks. To optimize equitable uptake of ePROs, oncology practices should offer several ePRO options (e.g., web-based, phone-based), as well as paper-based options, and consider the e-health literacy needs of patients during implementation., (© 2020. Springer Nature Switzerland AG.)

Purpose: To create a crosswalk that predicts Short Form 6D (SF-6D) utilities from Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores., Methods: The data come from prostate cancer patients enrolled in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS, N = 1016). Cross-sectional data from 12- to 24-month follow-up were used as estimation and validation datasets, respectively. Participants' SF-12 scores were used to generate SF-6D utilities in both datasets. Beta regression mixture models were used to evaluate SF-6D utilities as a function of MAX-PC scores, race, education, marital status, income, employment status, having health insurance, year of cancer diagnosis and clinically significant prostate cancer-related anxiety (PCRA) status in the estimation dataset. Models' predictive accuracies (using mean absolute error [MAE], root mean squared error [RMSE], Akaike information criterion [AIC] and Bayesian information criterion [BIC]) were examined in both datasets. The model with the highest prediction accuracy and the lowest prediction errors was selected as the crosswalk., Results: The crosswalk had modest prediction accuracy (MAE = 0.092, RMSE = 0.114, AIC = - 2708 and BIC = - 2595.6), which are comparable to prediction accuracies of other SF-6D crosswalks in the literature. About 24% and 52% of predictions fell within ± 5% and ± 10% of observed SF-6D, respectively. The observed mean disutility associated with acquiring clinically significant PCRA is 0.168 (standard deviation = 0.179)., Conclusion: This study provides a crosswalk that converts MAX-PC scores to SF-6D utilities for economic evaluation of clinically significant PCRA treatment options for prostate cancer survivors., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: This study aimed to examine psychometric properties of a caregiver version of the well-established Functional Assessment of Cancer Therapy-General Scale (FACT-G) after conducting focus groups and obtaining expert input., Methods: We made minor wording modifications to the Patient FACT-G to enable caregivers to report how the illness affected their overall quality of life (QOL) and well-being on four subscales (physical, social, emotional, functional). We tested the acceptability, precision, factor structure, reliability and validity of the Caregiver FACT-G among partners of prostate cancer patients (N = 263) and caregivers (spouses, siblings, adult children) of patients with advanced cancer (breast, lung, colorectal, prostate) (N = 484) using data from two Randomized Clinical Trials (RCTs)., Results: With a factor structure similar to the Patient FACT-G, Caregiver FACT-G was acceptable and precise in measuring caregiver QOL, with high inter-factor correlations and internal consistency reliability (Cronbach's alphas 0.81-0.91). The Caregiver FACT-G had strong convergent validity demonstrated by significant positive correlations with caregiver self-efficacy (0.25-0.63), dyadic communication (0.18-0.51), and social support (0.18-0.54) in both samples. It also had strong discriminant validity evidenced by significant inverse correlations with negative appraisal of caregiving (- 0.37 to - 0.69), uncertainty (- 0.28 to - 0.53), hopelessness (- 0.25 to - 0.60), and avoidant coping (- 0.26 to - 0.58) in both samples. Caregivers' baseline FACT-G scores were significantly associated with their physical (0.23) and mental well-being (0.54; 4-month follow-up) and their depression (- 0.69; 3-month follow-up), indicating strong predictive validity., Conclusion: This is the first study evaluating the psychometric properties of the Caregiver FACT-G. More psychometric testing is warranted, especially among caregivers of diverse sociocultural backgrounds.

Purpose: Gastrointestinal (GI) symptoms pose a significant burden to patients receiving chemoradiation therapy (CRT) for anal cancer; however, the impact of symptoms from the patient perspective has not been quantified. This retrospective study examined and compared patient and clinician reports of acute GI toxicity during CRT., Materials and Methods: Patients treated with definitive RT using intensity-modulated radiation therapy for anal cancer between 9/09 and 11/12 were reviewed. Median RT dose was 56 Gy (range 45-56), and 76 patients (97%) received concurrent 5-fluorouracil-based chemotherapy. During RT, patients completed the 7-item Bowel Problem Scale (BPS) weekly. Clinicians assessed toxicity separately using CTCAE v. 3.0. Scores of BPS ≥ 3 and CTCAE ≥ 1 were considered to be clinically meaningful. Agreement of the two assessments was evaluated by Cohen's kappa coefficient., Results: Seventy-eight patients completed at least one BPS and had a corresponding clinician assessment. Patients reporting scores of ≥3 was highest at week 5 (n = 68) for diarrhea (44.1%), proctitis (57.4%), and mucus (48.4%), while urgency (47.6%), tenesmus (31.7%), and cramping (27%) were highest at week 4 (n = 63). Baseline bleeding scores (26.7%; score ≥3) improved during treatment (13.4% at week 5). "Poor" agreement was observed between patient- and clinician-reported proctitis (Cohen's k = 0.11; n = 58); however, there was "good" agreement for diarrhea (Cohen's k = 0.68; n = 58)., Conclusions: Acute GI toxicity during definitive CRT for anal cancer was most significant during weeks 4-5, while rectal bleeding improved during treatment. Discrepancies in patient- and clinician-reported symptoms demonstrate the potential for patient-reported outcomes to be useful tools for anal cancer clinical assessments.

Purpose: To describe the prevalence, severity, and risk factors of chemotherapy-induced peripheral neuropathy (CIPN) and its impact on function and quality of life (QOL) among women treated for breast cancer in a large U.S. Community Oncology practice., Methods: Women previously treated with taxane-based chemotherapy for early-stage breast cancer completed the EORTC QLQ-C30, QLQ-BR23, and QLQ-CIPN20. Subscales are scored 0-100; higher scores indicate greater symptom severity. Pre-specified hypotheses were tested., Results: 126 women with mean age 56.7 years (SD 11.8) were stage I-II (79.4%) or stage III (20.6%) at the time of the survey; 65.1% were White and 27.8% were Black or African American. The mean time since last taxane chemotherapy cycle was 144.9 weeks (SD 112.9). 73.0% reported having CIPN. QLQ-CIPN20 mean scores for the sensory, motor, and autonomic subscales were 18.9 (SD 23.1), 18.6 (SD 18.7), and 17.1 (SD 21.8), respectively. CIPN symptom severity was negatively correlated with global health status/QOL and physical and role functioning (range of r = -0.46 to -0.72). It was not associated with age, body mass index, diabetes, or cumulative taxane dosage, but was greater for Black or African American women (e.g., sensory, p < 0.002). CIPN sensory impairment was marginally greater for patients treated with paclitaxel compared to docetaxel (p < 0.064)., Conclusions: CIPN was prevalent in this community oncology practice and significantly impacts function and QOL. These data highlight the importance of developing methods to mitigate CIPN, and for screening for CIPN particularly among Black or African American women.

Purpose: This study aims to characterize the symptom burden and life challenges that chordoma patients and their caregivers experience., Methods: In this cross-sectional study, we analyzed data from the Chordoma Foundation online community survey conducted in 2014. Frequency counts and percentages were calculated to determine the prevalence of self-reported symptoms and life challenges in the sample. We used Fisher's exact test to compare self-reported symptoms among subgroups with different disease status, tumor locations, and treatments received., Results: Among the survey participants, 358 identified themselves as chordoma patients and 208 as caregivers. The majority of the patients were over 45 years (72%), male (56%), educated beyond high school degree (87%), and from North America (77%). Skull base was the most prevalent tumor location (40%). Chronic pain (38%) was the most commonly reported symptom followed by depression or severe anxiety (35%), and chronic fatigue (34%). Among patients, the most commonly-reported challenges included delayed diagnosis (37%), long-term disability (33%), and change in career or reduced ability to work (33%). For caregivers, grief (55%), delayed diagnosis (47%), and difficulty helping the patient cope with his or her disease (45%) were most common., Conclusions: Our study findings suggest a high symptom burden and life challenges among chordoma patients and their caregivers. This study provides preliminary, limited estimates of the prevalence of a wide range of self-reported symptoms and challenges that will inform the assessment of patient-reported outcomes in future clinical trials and help clinicians better manage chordoma patients' symptoms.

Purpose: To assess the equivalence of patient-reported outcome (PRO) survey responses across Web, interactive voice response system (IVRS), and paper modes of administration., Methods: Postoperative colorectal cancer patients with home Web/e-mail and phone were randomly assigned to one of the eight study groups: Groups 1-6 completed the survey via Web, IVRS, and paper, in one of the six possible orders; Groups 7-8 completed the survey twice, either by Web or by IVRS. The 20-item survey, including the MSKCC Bowel Function Instrument (BFI), the LASA Quality of Life (QOL) scale, and the Subjective Significance Questionnaire (SSQ) adapted to bowel function, was completed from home on consecutive days. Mode equivalence was assessed by comparison of mean scores across modes and intraclass correlation coefficients (ICCs) and was compared to the test-retest reliability of Web and IVRS., Results: Of 170 patients, 157 completed at least one survey and were included in analysis. Patients had mean age 56 (SD = 11), 53% were male, 81% white, 53% colon, and 47% rectal cancer; 78% completed all assigned surveys. Mean scores for BFI total score, BFI subscale scores, LASA QOL, and adapted SSQ varied by mode by less than one-third of a score point. ICCs across mode were: BFI total score (Web-paper = 0.96, Web-IVRS = 0.97, paper-IVRS = 0.97); BFI subscales (range = 0.88-0.98); LASA QOL (Web-paper = 0.98, Web-IVRS = 0.78, paper-IVRS = 0.80); and SSQ (Web-paper = 0.92, Web-IVRS = 0.86, paper-IVRS = 0.79)., Conclusions: Mode equivalence was demonstrated for the BFI total score, BFI subscales, LASA QOL, and adapted SSQ, supporting the use of multiple modes of PRO data capture in clinical trials.

Aims: We evaluated pedometry as a novel patient-centered outcome because it enables passive continuous assessment of activity and may provide information about the consequences of symptomatic toxicity complementary to self-report., Methods: Adult patients undergoing hematopoietic cell transplant (HCT) wore pedometers and completed PRO assessments during transplant hospitalization (4 weeks) and 4 weeks post-discharge. Patient reports of symptomatic treatment toxicities (single items from PRO-CTCAE, http://healthcaredelivery.cancer.gov/pro-ctcae ) and symptoms, physical health, mental health, and quality of life (PROMIS(®) Global-10, http://nih.promis.org ), assessed weekly with 7-day recall on Likert scales, were compared individually with pedometry data, summarized as average daily steps per week, using linear mixed models., Results: Thirty-two patients [mean age 55 (SD = 14), 63 % male, 84 % white, 56 % autologous, 43 % allogeneic] completed a mean 4.6 (SD = 1.5, range 1-8) evaluable assessments. Regression model coefficients (β) indicated within-person decrements in average daily steps were associated with increases in pain (β = -852; 852 fewer steps per unit increase in pain score, p < 0.001), fatigue (β = -886, p < 0.001), vomiting (β = -518, p < 0.01), shaking/chills (β = -587, p < 0.01), diarrhea (β = -719, p < 0.001), shortness of breath (β = -1018, p < 0.05), reduction in carrying out social activities (β = 705, p < 0.01) or physical activities (β = 618, p < 0.01), and global physical health (β = 101, p < 0.001), but not global mental health or quality of life., Conclusions: In this small sample of HCT recipients, more severe symptoms, impaired physical health, and restrictions in the performance of usual daily activities were associated with statistically significant decrements in objectively measured daily steps. Pedometry may be a valuable outcome measure and validation anchor in clinical research.

Purpose: The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library., Methods: Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25% patients., Results: One hundred and twenty-seven patients participated (35% ≤high school, 28% non-white, and 59% female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated., Conclusions: This study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.