Patient‐reported outcomes in the Translational Breast Cancer Research Consortium

Bowen, Deborah J.; Shinn, Eileen H.; Gregrowski, Sophie; Kimmick, Gretchen; Dominici, Laura; Frank, Elizabeth S.; Smith, Karen L.; Rocque, Gabrielle Betty; Ruddy, Kathryn J.; Pollastro, Teri; Melisko, Michelle; Ballinger, Tarah J.; Fayanju, Oluwadamilola M.; Wolff, Antonio C.

doi:10.1002/cncr.32615

Cited by 6 publications

(5 citation statements)

References 46 publications

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“…We also reviewed the BCA PROM recommendations made by 2 consortia, namely International Consortium for Health Outcome Measures (ICHOM), 12 and Translational Breast Cancer Research Consortium (TBCRC). 13 We have verified that our PROMs cover the core outcome set described in the recommendations.…”

Section: Methodsmentioning

confidence: 60%

“…For such symptoms, items from the FACT-Endocrine Symptoms (ES) may be used as ad hoc items. 13 Similar suggestions may be made for mental health and a more granular assessment of pain and other symptom clusters. Last but not least, patients should have the option to make free-text entries to report their concerns through the PFT, and such reports can be used to invent more ad hoc items for uncommon symptoms in subsequent surveys in an individualized manner.…”

Section: Resultsmentioning

confidence: 84%

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Selecting patient-reported outcome measures for a patient-facing technology

Raj,

Cho,

Jiang

et al. 2023

JAMIA Open

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Objective This article provides insight into our process and considerations for selecting patient-reported outcome measures (PROMs) designed for self-reporting symptoms and quality-of-life among breast cancer (BCA) patients undergoing oral anticancer agent treatment via a patient-facing technology (PFT) platform. Methods Following established guidelines, we conducted a thorough assessment of a specific set of PROMs, comparing their content to identify the most suitable options for studying BCA patients. Results We recommend utilizing the combination of EORTC QLQ-C30 + EORTC QLQ-BR45 as the preferred instrument, especially when developing a dedicated “breast cancer-only” application. Discussion When developing and maintaining a dashboard for a PFT platform that includes multiple cancer types, it is important to consider the feasibility of interface design and workload. To achieve this, we recommend using PRO-CTCAE+PROMIS 10 GH for the PFT. Moreover, it is important to consider adding ad hoc items to complement the chosen PROM(s). Conclusion This article describes our efforts to identify PROMs for self-reported data while considering patient and developer burdens, providing guidance to PFT developers facing similar challenges in PROM selection.

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Section: Methodsmentioning

confidence: 60%

Section: Resultsmentioning

confidence: 84%

Selecting patient-reported outcome measures for a patient-facing technology

Raj,

Cho,

Jiang

et al. 2023

JAMIA Open

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“…For breast cancer specifically, the Translational Breast Cancer Research Consortium offers recommendations for preferred, validated PRO measures (PROMs). 8 PROs are particularly important in cancer therapy de-escalation trials for several reasons. As these trials can rarely be blinded, substantive patient buy-in and shared decision-making are essential.…”

Section: Introductionmentioning

confidence: 99%

“…International, consensus-based guidelines exist regarding optimal collection, reporting, and ethical inclusion of PROs in clinical trials. For breast cancer specifically, the Translational Breast Cancer Research Consortium offers recommendations for preferred, validated PRO measures (PROMs) …”

Section: Introductionmentioning

confidence: 99%

Patient-Reported Outcomes of Omission of Breast Surgery Following Neoadjuvant Systemic Therapy

Johnson,

Lin,

Shen

et al. 2023

JAMA Netw Open

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ImportancePatients should have an active role in decisions about pursuing or forgoing specific therapies in treatment de-escalation trials.ObjectiveTo evaluate longitudinal patient-reported outcomes (PROs) encompassing decisional comfort and health-related quality of life (HRQOL) among patients who elected to enroll in a clinical trial evaluating radiotherapy alone, without breast surgery, for invasive breast cancers with exceptional response to neoadjuvant systemic therapy (NST).Design, Setting, and ParticipantsProspective, single-group, phase 2 clinical trial at 7 US medical centers. Women aged 40 years or older with invasive cT1-2 N0-1 M0 triple-negative or human epidermal growth factor receptor 2 (ERBB2)–positive breast cancer with no pathologic evidence of residual disease following standard NST enrolled from March 6, 2017, to November 9, 2021. Validated PRO measures were administered at baseline and 6, 12, and 36 months post-radiotherapy. Data were analyzed from January to February 2023.InterventionsPRO measures included the Decision Regret Scale (DRS), Functional Assessment of Cancer Therapy—Lymphedema (FACT-B+4), and Breast Cancer Treatment Outcomes Scale (BCTOS).Main Outcomes and MeasuresChanges in PRO measure scores and subscores over time.ResultsAmong 31 patients, the median (IQR) age was 61 (56-66) years, 26 (84%) were White, and 26 (84%) were non-Hispanic. A total of 15 (48%) had triple-negative disease and 16 (52%) had ERBB2-positive disease. Decisional comfort was high at baseline (median [IQR] DRS score 10 [0-25] on a 0-100 scale, with higher scores indicating higher decisional regret) and significantly increased over time (median [IQR] DRS score at 36 months, 0 [0-20]; P &lt; .001). HRQOL was relatively high at baseline (median [IQR] FACT-B composite score 121 [111-134] on a 0-148 scale, with higher scores indicating higher HRQOL) and significantly increased over time (median [IQR] FACT-B score at 36 months, 128 [116-137]; P = .04). Perceived differences between the affected breast and contralateral breast were minimal at baseline (median [IQR] BCTOS score 1.05 [1.00-1.23] on a 1-4 scale, with higher scores indicating greater differences) and increased significantly over time (median [IQR] BCTOS score at 36 months, 1.36 [1.18-1.64]; P &lt; .001). At 36 months postradiotherapy, the cosmetic subscore was 0.45 points higher than baseline (95% CI, 0.16-0.74; P = .001), whereas function, pain, and edema subscores were not significantly different than baseline.Conclusions and RelevanceIn this nonrandomized phase 2 clinical trial, analysis of PROs demonstrated an overall positive experience for trial participants, with longitudinal improvements in decisional comfort and overall HRQOL over time and minimal lasting adverse effects of therapy.Trial RegistrationClinicalTrials.gov Identifier: NCT02945579

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“…Patient-reported outcomes (PROs) refer to a generic manner of measuring subjectively perceived health status [ 1 ] that is self-reported by the patient [ 2 , 3 ]. For economic health-technology-assessment (HTA) evaluations, the generic EQ-5D is the most commonly recommended multi-attribute utility instrument in pharmacoeconomic guidelines internationally [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Patient reported outcomes based on EQ-5D-5L questionnaires in head and neck cancer patients: a real-world study

et al. 2022

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Objective Health economic comparisons of various therapies are often based on health-related quality of life (HRQOL) using EQ-5D questionnaires within the framework of clinical trials. This real-world study prospectively evaluates the patient reported outcomes (PROs)-based HRQOL of head-and-neck (H&N) cancer patients undergoing modern radiotherapy (RT) to reflect PRO trajectories. Methods All H&N cancer patients treated in our clinic between July 2019 and December 2020 who completed the self-reported validated EQ-5D-5L questionnaire (health state index (HI) and Visual Analog Scale (VAS)) at baseline, end of radiotherapy, and at each respective follow up (FU) were included. Descriptive analysis of clinical and sociodemographic data, the frequency and level of each dimension was conducted. To assess the significance of therapy-induced HRQOL changes within and between the group, a distribution-based approach was used. Results Altogether, 366 participants completed a total of 565 questionnaires. For the whole cohort, HI at baseline was 0.804 (±0.208), 0.830 (±0.162) at RT completion, 0.812 (±0.205) at the first follow-up, and 0.769 (±0.224) at the second follow-up. The respective VAS values were 62.06 (±23,94), 66.73 (±82.20), 63.30 (±22.74), and 65.48 (±23.39). Females showed significantly lower HI values compared to males, but only at baseline (p = 0.034). Significantly lower HI values were also seen in patients with definitive RT as compared to adjuvant RT at baseline (p = 0.023), the second follow-up (p = 0.047), and the third follow-up (p = 0.010). As compared to outpatients, inpatients had significantly lower HI values at RT completion (p = 0.017), the second follow-up (p = 0.007), and the third follow-up (p = 0.031). Subgroup analyses by age (< 65 vs. ≥65) and smoking status (smokers vs. non-smokers) showed no difference at any time point. Conclusion PROs demonstrated detectability of time- and intra−/inter-group therapy-induced HRQOL changes. A further detailed exploration of EQ-5D-5L responsiveness for H&N cancer patients is required.

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Patient‐reported outcomes in the Translational Breast Cancer Research Consortium

Cited by 6 publications

References 46 publications

Selecting patient-reported outcome measures for a patient-facing technology

Selecting patient-reported outcome measures for a patient-facing technology

Patient-Reported Outcomes of Omission of Breast Surgery Following Neoadjuvant Systemic Therapy

Patient reported outcomes based on EQ-5D-5L questionnaires in head and neck cancer patients: a real-world study

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