Cited by 414Cancer survivorship and careMobile Health and mHealth ApplicationsTelemedicine and Telehealth Implementation

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Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial

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Basch, Ethan, Schrag, Deborah, Henson, Sydney, Jansen, Jennifer, Ginos, Brenda, Stover, Angela M., Carr, Philip, Spears, Patricia A., Jonsson, Mattias, Deal, Allison M., Bennett, Antonia V., Thanarajasingam, Gita, Rogak, Lauren J., Reeve, Bryce B., Snyder, Claire, Bruner, Deborah, Cella, David, Kottschade, Lisa A., Perlmutter, Jane, Geoghegan, Cindy, Samuel-Ryals, Cleo A., Given, Barbara, Mazza, Gina L., Miller, Robert, Strasser, Jon F., Zylla, Dylan M., Weiss, Anna, Blinder, Victoria S., Dueck, Amylou C.·2022·JAMA

DOI 10.1001/jama.2022.9265PMC PMC9168923

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Abstract

Importance: Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene. Objective: To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: 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. Results: 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). Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT03249090.

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Authors: Basch, E., Schrag, D., Henson, S., Jansen, J., Ginos, B., Stover, A. M., Carr, P., Spears, P. A., Jonsson, M., Deal, A. M., Bennett, A. V., Thanarajasingam, G., Rogak, L. J., Reeve, B. B., Snyder, C., Bruner, D., Cella, D., Kottschade, L. A., Perlmutter, J., Geoghegan, C., Samuel-Ryals, C. A., Given, B., Mazza, G. L., Miller, R., Strasser, J. F., Zylla, D. M., Weiss, A., Blinder, V. S., & Dueck, A. C.
Affiliations: University of North Carolina at Chapel Hill (US)
Memorial Sloan Kettering Cancer Center (US)
Mayo Clinic in Arizona (US)
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill
Mayo Clinic (US)
Duke University (US)
Johns Hopkins University (US)
Emory University (US)
Northwestern University (US)
Gemini Group, Ann Arbor, Michigan
Patient and Partners, Madison, Connecticut
Michigan State University (US)
American Society of Clinical Oncology (US)
Christiana Care Health System (US)
Park Nicollet Health Services (US)
Brigham and Women's Hospital (US)
Corresponding author: Basch, Ethan
ORCID: Basch, Ethan
Schrag, Deborah
Jansen, Jennifer
Stover, Angela M.
Spears, Patricia A.
Deal, Allison M.
Bennett, Antonia V.
Thanarajasingam, Gita
Rogak, Lauren J.
Reeve, Bryce B.
Snyder, Claire
Bruner, Deborah
Cella, David
Kottschade, Lisa A.
Perlmutter, Jane
Geoghegan, Cindy
Given, Barbara
Mazza, Gina L.
Miller, Robert
Zylla, Dylan M.
Weiss, Anna
Blinder, Victoria S.
Dueck, Amylou C.
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2022-06-28
Volume: 327
Issue: 24
Pages: 2413
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.2022.9265
PMC: PMC9168923
OpenAlex: W4281790169
Cited by: 413
References: 32
Citations by year: 2026: 117 · 2025: 112 · 2024: 102 · 2023: 71 · 2022: 11
FWCI: 30.97
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: JAMA (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
UNC Libraries
Funders: Patient-Centered Outcomes Research Institute
National Cancer Institute (P30CA008748, P30CA016086, P30CA014236)
Topics: Health Sciences › Medicine › Oncology › Cancer survivorship and care
Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
Keywords: electronic symptom monitoring, patient-reported outcomes, metastatic cancer, health-related quality of life, physical function, symptom management, EORTC QLQ-C30, internet-based survey, community oncology practice, early symptom detection, cancer treatment side effects
MeSH terms: Patient Reported Outcome Measures, Adult, Electronics, Female, Health Status Indicators, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasms, Quality of Life, Surveys and Questionnaires, Neoplasms, Second Primary, Telemedicine, Monitoring, Ambulatory, Internet

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Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial

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