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 Bruner
  • Laura J Hanisch
  • Bryce B Reeve
  • Andy M Trotti
  • Deborah Schrag
  • Laura Sit
  • Tito R Mendoza
  • Lori Minasian
  • Ann O’Mara
  • Andrea M Denicoff
  • Julia H Rowland
  • Michael Montello
  • Cindy Geoghegan
  • Amy P Abernethy
  • Steven B Clauser
  • Kathleen Castro
  • Sandra A Mitchell
  • Laurie Burke
  • Ann Marie Trentacosti
  • Ethan M Basch
Article

DOI: 10.1007/s13142-011-0025-3

Cite this article as:
Bruner, D.W., Hanisch, L.J., Reeve, B.B. et al. Behav. Med. Pract. Policy Res. (2011) 1: 110. doi:10.1007/s13142-011-0025-3

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 outcomesSymptoms, adverse eventsOncologyCancer, Clinical trialsToxicity, safetyTolerabilityComparative effectiveness researchCooperative groupsNational Cancer Institute

Copyright information

© Society of Behavioral Medicine 2011

Authors and Affiliations

  • Deborah Watkins Bruner
    • 1
  • Laura J Hanisch
    • 2
  • Bryce B Reeve
    • 3
  • Andy M Trotti
    • 4
  • Deborah Schrag
    • 5
  • Laura Sit
    • 6
  • Tito R Mendoza
    • 7
  • Lori Minasian
    • 8
  • Ann O’Mara
    • 9
  • Andrea M Denicoff
    • 10
  • Julia H Rowland
    • 11
  • Michael Montello
    • 12
  • Cindy Geoghegan
    • 13
  • Amy P Abernethy
    • 14
  • Steven B Clauser
    • 15
  • Kathleen Castro
    • 16
  • Sandra A Mitchell
    • 17
  • Laurie Burke
    • 18
  • Ann Marie Trentacosti
    • 19
  • Ethan M Basch
    • 20
  1. 1.School of Nursing, Abramson Cancer CenterUniversity of PennsylvaniaPhiladelphiaUSA
  2. 2.Cancer Control and Outcomes Program, Abramson Cancer CenterUniversity of PennsylvaniaPhiladelphiaUSA
  3. 3.Lineberger Comprehensive Cancer Center, Department of Health Policy and Management, Gillings School of Global Public HealthUniversity of North Carolina at Chapel HillChapel HillUSA
  4. 4.H. Lee Moffitt Cancer Center and Research InstituteTampaUSA
  5. 5.Dana-Farber Cancer InstituteGastrointestinal Cancer CenterBostonUSA
  6. 6.Health Outcomes Group, Department of Epidemiology and BiostatisticsMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  7. 7.Department of Symptom ResearchThe University of Texas MD Anderson Cancer CenterHoustonUSA
  8. 8.Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, NIHBethesdaUSA
  9. 9.Palliative Care Research, Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer InstituteBethesdaUSA
  10. 10.Clinical Investigations Branch, CTEP, Division of Cancer Treatment and Diagnosis, National Cancer InstituteBethesdaUSA
  11. 11.Office of Cancer Survivorship, Division of Cancer Control and Population SciencesNational Cancer Institute, NIH/DHHSBethesdaUSA
  12. 12.National Cancer InstituteClinical Trials TechnologyBethesdaUSA
  13. 13.Breast Cancer Network of StrengthChicagoUSA
  14. 14.Department of MedicineDuke University School of MedicineDurhamUSA
  15. 15.Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population SciencesNational Cancer InstituteBethesdaUSA
  16. 16.Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population SciencesNational Cancer InstituteBethesdaUSA
  17. 17.Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population SciencesNational Cancer InstituteBethesdaUSA
  18. 18.Study Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA
  19. 19.Study Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA
  20. 20.Health Outcomes Group, Department of Epidemiology and BiostatisticsMemorial Sloan-Kettering Cancer CenterNew YorkUSA