Oncology patient preferences in reporting on symptoms

Background: Collecting patient reported outcomes (PROs) in oncology clinical trials is becoming increasingly important. However, there is limited consensus on the most appropriate frequency of PRO administration in oncology trials. The aim of this preliminary study is to examine the perspective of participants with a cancer diagnosis on the importance of completing PROs and to identify at what frequency participants prefer to report on their cancer-related symptoms.Methods: 166 participants with a self-reported cancer diagnosis completed a multiple-choice online survey regarding perceptions of symptom importance and reporting preferences.Results: When asked about the benefit of reporting oncology-related symptoms daily, 44% of participants indicated there would be “very much” a benefit, 29% indicated there would be “quite a bit” of benefit, and 17% indicated there would be “somewhat” of a benefit. When asked about how frequently they would prefer to report symptoms, 41% of participants preferred “as they occur,” 36% preferred “once a day,” 18% preferred “once a week,” 4% preferred “twice a day,” and 1% preferred “every 4 hours”.Conclusions: PROs in oncology clinical research are most often collected at weekly, monthly, or longer intervals; however, meaningful fluctuations in cancer-related symptoms can occur more frequently. While concerns regarding patient burden are often raised to support infrequent reporting, these data suggest that participants would like to report symptoms with greater frequency, as episodic and daily reporting options were most popular. Based on these data, more frequent PRO data capture is not only feasible but perceived as important by individuals with cancer.

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Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2020.06.030 ◽

2020 ◽

Vol 108 (4) ◽

pp. 950-959 ◽

Cited By ~ 1

Author(s):

Stephanie L. Pugh ◽

Joseph P. Rodgers ◽

Katherine A. Yeager ◽

Ronald C. Chen ◽

Benjamin Movsas ◽

...

Keyword(s):

Clinical Trials ◽

Patient Reported Outcomes ◽

Data Capture ◽

Electronic Data Capture ◽

Electronic Data ◽

Patient Reported ◽

Oncology Clinical Trials

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PCN223 Recommendations For The Collection Of Patient-Reported Outcomes (PRO) Data In The Post-Progression And Post-Treatment Setting Following Oncology Clinical Trials

Value in Health ◽

10.1016/j.jval.2021.04.313 ◽

2021 ◽

Vol 24 ◽

pp. S61

Author(s):

O. Oladapo ◽

D. D'Alessio ◽

S. Vallow

Keyword(s):

Clinical Trials ◽

Patient Reported Outcomes ◽

Post Treatment ◽

Treatment Setting ◽

Patient Reported ◽

Oncology Clinical Trials

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PCN126 REVIEW OF PATIENT-REPORTED OUTCOMES IN PHASE II ONCOLOGY CLINICAL TRIALS

Value in Health ◽

10.1016/s1098-3015(11)72021-6 ◽

2010 ◽

Vol 13 (7) ◽

pp. A275

Author(s):

S Danheiser ◽

F Barkalow ◽

HW Finnern

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Patient Reported Outcomes ◽

Patient Reported ◽

Oncology Clinical Trials

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Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials

Clinical Trials ◽

10.1177/1740774518799985 ◽

2018 ◽

Vol 15 (6) ◽

pp. 616-623 ◽

Cited By ~ 7

Author(s):

Peter C Trask ◽

Amylou C Dueck ◽

Elisabeth Piault ◽

Alicyn Campbell

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Patient Reported Outcomes ◽

Selection Process ◽

Late Phase ◽

Relevant Information ◽

Specific Patient ◽

Patient Reported ◽

Oncology Clinical Trials ◽

The Common

As new cancer treatment regimens demonstrate increased potential to improve patients’ survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment’s tolerability. The U.S. Food and Drug Administration has recommended using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in clinical trials. A practical guideline is needed to inform a priori selection of specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items for use in any given industry-sponsored oncology clinical trial. Standardizing this selection process will foster systematic and consistent data collection as part of drug development and enhance our knowledge on how to use patient-relevant information as part of a treatment’s risk/benefit assessment. This article presents methods and consensus recommendations for selecting specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items to include in early-phase and late-phase oncology clinical trials.

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Current Status of Patient-Reported Outcomes in Industry-Sponsored Oncology Clinical Trials and Product Labels

Journal of Clinical Oncology ◽

10.1200/jco.2007.11.3845 ◽

2007 ◽

Vol 25 (32) ◽

pp. 5087-5093 ◽

Cited By ~ 30

Author(s):

Kathleen Gondek ◽

Pierre-Philippe Sagnier ◽

Kim Gilchrist ◽

J. Michael Woolley

Keyword(s):

Clinical Trials ◽

Patient Reported Outcomes ◽

Symptom Assessment ◽

Current Status ◽

Cancer Therapies ◽

Package Inserts ◽

Patient Reported ◽

Oncology Clinical Trials ◽

Related Quality ◽

The Impact

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov , the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.

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Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

Journal of Clinical Oncology ◽

10.1200/jco.2007.11.3324 ◽

2007 ◽

Vol 25 (32) ◽

pp. 5051-5057 ◽

Cited By ~ 51

Author(s):

Deborah Watkins Bruner ◽

Charlene J. Bryan ◽

Neil Aaronson ◽

C. Craig Blackmore ◽

Michael Brundage ◽

...

Keyword(s):

Clinical Trials ◽

Patient Reported Outcomes ◽

Online Survey ◽

Cancer Control ◽

The United States ◽

Cancer Clinical Trials ◽

Cooperative Group ◽

Cooperative Groups ◽

End Points ◽

Patient Reported

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

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