Article

Translational Behavioral Medicine

, Volume 1, Issue 1, pp 110-122

Stakeholder perspectives on implementing the National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  • Deborah Watkins BrunerAffiliated withSchool of Nursing, Abramson Cancer Center, University of Pennsylvania
  • , Laura J HanischAffiliated withCancer Control and Outcomes Program, Abramson Cancer Center, University of Pennsylvania
  • , Bryce B ReeveAffiliated withLineberger Comprehensive Cancer Center, Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
  • , Andy M TrottiAffiliated withH. Lee Moffitt Cancer Center and Research Institute
  • , Deborah SchragAffiliated withDana-Farber Cancer Institute, Gastrointestinal Cancer Center
  • , Laura SitAffiliated withHealth Outcomes Group, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center
  • , Tito R MendozaAffiliated withDepartment of Symptom Research, The University of Texas MD Anderson Cancer Center
  • , Lori MinasianAffiliated withCommunity Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, NIH
  • , Ann O’MaraAffiliated withPalliative Care Research, Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute
    • , Andrea M DenicoffAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaClinical Investigations Branch, CTEP, Division of Cancer Treatment and Diagnosis, National Cancer Institute
    • , Julia H RowlandAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaOffice of Cancer Survivorship, Division of Cancer Control and Population Sciences, National Cancer Institute, NIH/DHHS
    • , Michael MontelloAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaNational Cancer Institute, Clinical Trials Technology
    • , Cindy GeogheganAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaBreast Cancer Network of Strength
    • , Amy P AbernethyAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaDepartment of Medicine, Duke University School of Medicine
    • , Steven B ClauserAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaOutcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute
    • , Kathleen CastroAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaOutcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute
    • , Sandra A MitchellAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaOutcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute
    • , Laurie BurkeAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaStudy Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration
    • , Ann Marie TrentacostiAffiliated withSchool of Nursing, Abramson Cancer Center, University of PennsylvaniaStudy Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration
    • , Ethan M BaschAffiliated withCancer Control and Outcomes Program, Abramson Cancer Center, University of PennsylvaniaHealth Outcomes Group, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center Email author 

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Abstract

The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the “PRO-CTCAE.” The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI’s cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.

Keywords

Patient-reported outcomes Symptoms, adverse events Oncology Cancer, Clinical trials Toxicity, safety Tolerability Comparative effectiveness research Cooperative groups National Cancer Institute