Can electronic web-based technology improve quality of life data collection? Analysis of Radiation Therapy Oncology Group 0828.
OBJECTIVE
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
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.
Henry Ford Health System, Detroit, Michigan. Electronic address: bmovsas1@hfhs.org.
Benjamin
B
Movsas
RTOG Statistical Center, Philadelphia, Pennsylvania.
Daniel
D
Hunt
Emory University School of Nursing, Atlanta, Georgia.
Deborah
D
Watkins-Bruner
Duke University School of Medicine, Durham, North Carolina.
W Robert
WR
Lee
Summa Health System Hospital, Akron, Ohio.
Heather
H
Tharpe
Kaiser Permanente Santa Clara Medical Center, Santa Clara, California.
Desiree
D
Goldstein
York Cancer Center, Hanover, Pennsylvania.
Joan
J
Moore
McMaster University, Juravinski Cancer Center Hamilton Health Sciences, Hamilton, Ontario, Canada.
Ian S
IS
Dayes
North Shore-Long Island Jewish Health System, Monter Cancer Center, Lake Success, New York.
Sara
S
Parise
Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Howard
H
Sandler
D000368:Aged; D003625:Data Collection / Q000379:methods*; D057286:Electronic Health Records; D006751:Hospital Information Systems; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D018787:Radiation Oncology / Q000379:methods*; D011795:Surveys and Questionnaires