Skip to main content
Journal cover image

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

Publication ,  Journal Article
Bruner, DW; Hanisch, LJ; Reeve, BB; Trotti, AM; Schrag, D; Sit, L; Mendoza, TR; Minasian, L; O'Mara, A; Denicoff, AM; Rowland, JH; Montello, M ...
Published in: Transl Behav Med
March 2011

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Transl Behav Med

DOI

ISSN

1869-6716

Publication Date

March 2011

Volume

1

Issue

1

Start / End Page

110 / 122

Location

England

Related Subject Headings

  • 52 Psychology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Bruner, D. W., Hanisch, L. J., Reeve, B. B., Trotti, A. M., Schrag, D., Sit, L., … Basch, E. M. (2011). Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Transl Behav Med, 1(1), 110–122. https://doi.org/10.1007/s13142-011-0025-3
Bruner, Deborah Watkins, Laura J. Hanisch, Bryce B. Reeve, Andy M. Trotti, Deborah Schrag, Laura Sit, Tito R. Mendoza, 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).Transl Behav Med 1, no. 1 (March 2011): 110–22. https://doi.org/10.1007/s13142-011-0025-3.
Bruner, Deborah Watkins, 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).Transl Behav Med, vol. 1, no. 1, Mar. 2011, pp. 110–22. Pubmed, doi:10.1007/s13142-011-0025-3.
Bruner DW, Hanisch LJ, Reeve BB, Trotti AM, Schrag D, Sit L, Mendoza TR, Minasian L, O’Mara A, Denicoff AM, Rowland JH, Montello M, Geoghegan C, Abernethy AP, Clauser SB, Castro K, Mitchell SA, Burke L, Trentacosti AM, Basch EM. Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Transl Behav Med. 2011 Mar;1(1):110–122.
Journal cover image

Published In

Transl Behav Med

DOI

ISSN

1869-6716

Publication Date

March 2011

Volume

1

Issue

1

Start / End Page

110 / 122

Location

England

Related Subject Headings

  • 52 Psychology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences