PURPOSE: Missing data are a significant problem in clinical trials, particularly for quality of life (QOL), which cannot be obtained retrospectively.
The purpose of this study was to evaluate the feasibility of an electronic web-based strategy for QOL data collection in a cooperative group radiation oncology trial setting.
METHODS AND MATERIALS: Radiation Therapy Oncology Group (RTOG) 0828 was a prospective National Cancer Institute cooperative group companion study of RTOG-0415, a randomized study of conventional versus hypofractionated radiation. Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-0415 consented to using web-based technology for completing QOL. In RTOG-0415, using paper forms, the 6-month QOL compliance rate was 52%. The purpose of RTOG-0828 was to test the feasibility of a web-based strategy with the goal of increasing the 6-month QOL completion rate by 25% (from 52% to 77%) for a relative improvement of ~50%. The web-based tool used in this study was VisionTree Optimal Care (VTOC; VisionTree Software, Inc, San Diego, CA), a Health-Insurance-Portability-Accountability-Act secure, online technology that allows real-time tracking and e-mail reminders. The primary endpoint was the 6-month compliance rate for the validated QOL instrument, Expanded Prostate Index Composite.
RESULTS: The QOL completion rate at baseline was 98%. Compared with the prior 52% QOL completion rate at 6 months using paper forms, the QOL web-based completion rate at 6 months was 90% (2-sided P value < .001). At 12 months, the EPIC completion rate was 82% (compared with 36% using paper forms).
CONCLUSIONS: This RTOG study suggests that a web-based strategy to collect QOL appears to be feasible in the cooperative group radiation oncology trial setting and is associated with an increase in the 6-month QOL compliance rate compared with the prior method of using paper forms. The RTOG plans to further test this strategy in a head-and-neck cancer trial across all participating RTOG sites.
Written by:
Movsas B, Hunt D, Watkins-Bruner D, Lee WR, Tharpe H, Goldstein D, Moore J, Dayes IS, Parise S, Sandler H. Are you the author?
Henry Ford Health System, Detroit, Michigan; RTOG Statistical Center, Philadelphia, Pennsylvania; Emory University School of Nursing, Atlanta, Georgia; Duke University School of Medicine, Durham, North Carolina; Summa Health System Hospital, Akron, Ohio; Kaiser Permanente Santa Clara Medical Center, Santa Clara, California; York Cancer Center, Hanover, Pennsylvania; McMaster University, Juravinski Cancer Center Hamilton Health Sciences, Hamilton, Ontario, Canada; North Shore-Long Island Jewish Health System, Monter Cancer Center, Lake Success, New York; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Reference: Pract Radiat Oncol. 2014 May-Jun;4(3):187-91.
doi: 10.1016/j.prro.2013.07.014
PubMed Abstract
PMID: 24766686
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