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

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Translational Behavioral Medicine

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.

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Acknowledgments

This work was supported by the National Cancer Institute under contract HHSN261200800043C awarded to Dr. Ethan Basch, PI.

Author information

Authors and Affiliations

  1. School of Nursing, Abramson Cancer Center, University of Pennsylvania, Claire M. Fagin Hall, Room 330, 418 Curie Boulevard, Philadelphia, PA, 19104-4217, USA

    Deborah Watkins Bruner RN, PhD, FAAN

  2. Cancer Control and Outcomes Program, Abramson Cancer Center, University of Pennsylvania, Claire M. Fagin Hall, Room 330, 418 Curie Boulevard, Philadelphia, PA, 19104-4217, USA

    Laura J Hanisch PsyD

  3. Lineberger Comprehensive Cancer Center, Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 1101-D McGavran-Greenberg Building, 135 Dauer Drive, CB 7411, Chapel Hill, NC, 27599-7411, USA

    Bryce B Reeve PhD

  4. H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33612, USA

    Andy M Trotti MD

  5. Dana-Farber Cancer Institute, Gastrointestinal Cancer Center, 44 Binney Street, SM 205, Boston, MA, 02115, USA

    Deborah Schrag MD, MPH

  6. Health Outcomes Group, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 307 E.63rd Street, 2nd floor, New York, NY, 10065, USA

    Laura Sit

  7. Department of Symptom Research, The University of Texas MD Anderson Cancer Center, 1400 Pressler St Unit 1450, Room Number: FCT11.5074, Houston, TX, 77030, USA

    Tito R Mendoza PhD, MS, MEd

  8. Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, 6130 Executive Blvd, EPN, Room 2016, MSC-7340, Bethesda, MD, 20892-7340, USA

    Lori Minasian MD

  9. Palliative Care Research, Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd., EPN 2010, Bethesda, MD, 20892, USA

    Ann O’Mara PhD, RN, FAAN

  10. Clinical Investigations Branch, CTEP, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, 20892-7436, USA

    Andrea M Denicoff MS, RN, ANP

  11. Office of Cancer Survivorship, Division of Cancer Control and Population Sciences, National Cancer Institute, NIH/DHHS, 6116 Executive Blvd, Suite 404, MSC 8336, Bethesda, MD, 20892-8336, USA

    Julia H Rowland PhD

  12. National Cancer Institute, Clinical Trials Technology, 6130 Executive Blvd., Suite 7025, Bethesda, MD, 20892-7436, USA

    Michael Montello PharmD, MBA (Capt.)

  13. Breast Cancer Network of Strength, 135 South LaSalle Street, Chicago, IL, 60603, USA

    Cindy Geoghegan

  14. Department of Medicine, Duke University School of Medicine, 25165 Morris Building, Duke University Medical Center, Box 3436, Durham, NC, 27710, USA

    Amy P Abernethy MD

  15. Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 6130 Executive Boulevard—MSC 7344, Bethesda, MD, 20892-7344, USA

    Steven B Clauser PhD

  16. Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 6130 Executive Blvd, EPN 4091, Bethesda, MD, 20892, USA

    Kathleen Castro RN, MS, AOCN

  17. Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 6130 Executive Blvd., EPN 4088, Bethesda, MD, 20892, USA

    Sandra A Mitchell CRNP, PhD

  18. Study Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Building 22 Room 6462, 10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002, USA

    Laurie Burke RPh, MPH (Capt.)

  19. Study Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Building 22 Room 6411, 10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002, USA

    Ann Marie Trentacosti MD

  20. Health Outcomes Group, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 307 E.63rd Street, 2nd floor, New York, NY, 10065, USA

    Ethan M Basch MD, MSc

Authors
  1. Deborah Watkins Bruner RN, PhD, FAAN
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  2. Laura J Hanisch PsyD
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  3. Bryce B Reeve PhD
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  4. Andy M Trotti MD
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  5. Deborah Schrag MD, MPH
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  6. Laura Sit
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  7. Tito R Mendoza PhD, MS, MEd
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  8. Lori Minasian MD
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  9. Ann O’Mara PhD, RN, FAAN
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  10. Andrea M Denicoff MS, RN, ANP
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  11. Julia H Rowland PhD
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  12. Michael Montello PharmD, MBA
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  13. Cindy Geoghegan
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  14. Amy P Abernethy MD
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  15. Steven B Clauser PhD
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  16. Kathleen Castro RN, MS, AOCN
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  17. Sandra A Mitchell CRNP, PhD
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  18. Laurie Burke RPh, MPH
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  19. Ann Marie Trentacosti MD
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  20. Ethan M Basch MD, MSc
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Corresponding author

Correspondence to Ethan M Basch MD, MSc.

Additional information

Implications

Policymakers: Patient self-reporting provides essential information about the safety and effectiveness of drugs and devices which can aid setting treatment and reimbursement priorities.

Researchers: Patient-reported outcomes provide reliable and valid accounts of the symptoms experienced by patients during treatment, which can provide important study data and prompt new research questions.

Practitioners: Systems that allow patients to self-report their own side effects in real-time to providers have been demonstrated to improve symptom control, patient satisfaction, patient-clinician communication, and to aid in clinical decision-making.

APPENDIX

APPENDIX

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Bruner, D.W., Hanisch, L.J., Reeve, B.B. et al. Stakeholder perspectives on implementing the National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Behav. Med. Pract. Policy Res. 1, 110–122 (2011). https://doi.org/10.1007/s13142-011-0025-3

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  • DOI: https://doi.org/10.1007/s13142-011-0025-3

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