Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene.
To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes.
Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021.
In the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care.
The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available.
Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006).
In this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival.
ClinicalTrials.gov Identifier: NCT03249090.
JAMA. 2022 Jun 28 [Epub]
Ethan Basch, Deborah Schrag, Sydney Henson, Jennifer Jansen, Brenda Ginos, Angela M Stover, Philip Carr, Patricia A Spears, Mattias Jonsson, Allison M Deal, Antonia V Bennett, Gita Thanarajasingam, Lauren J Rogak, Bryce B Reeve, Claire Snyder, Deborah Bruner, David Cella, Lisa A Kottschade, Jane Perlmutter, Cindy Geoghegan, Cleo A Samuel-Ryals, Barbara Given, Gina L Mazza, Robert Miller, Jon F Strasser, Dylan M Zylla, Anna Weiss, Victoria S Blinder, Amylou C Dueck
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill., Memorial Sloan Kettering Cancer Center, New York, New York., Mayo Clinic, Scottsdale, Arizona., Division of Hematology, Mayo Clinic, Rochester, Minnesota., Duke Cancer Institute, Duke University School of Medicine, Durham, North Carolina., Johns Hopkins Schools of Medicine and Public Health, Baltimore, Maryland., Emory University, Atlanta, Georgia., Feinberg School of Medicine, Northwestern University, Chicago, Illinois., Department of Medical Oncology, Mayo Clinic, Rochester, Minnesota., Gemini Group, Ann Arbor, Michigan., Patient and Partners, Madison, Connecticut., College of Nursing, Michigan State University, East Lansing., American Society of Clinical Oncology, Alexandria, Virginia., Christiana Care Health Services, Wilmington, Delaware., The Cancer Research Center, HealthPartners/Park Nicollet, Minneapolis, Minnesota., Brigham and Women's Hospital, Boston, Massachusetts.