Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial

Ethan Basch¹, Deborah Schrag², Jennifer Jansen³, Sydney Henson³, Brenda Ginos⁴, Angela M Stover³, Philip Carr³, Patricia A Spears³, Mattias Jonsson³, Allison M Deal³, Antonia V Bennett³, Gita Thanarajasingam⁵, Lauren Rogak⁶, Bryce B Reeve⁷, Claire Snyder⁸, Deborah Bruner⁹, David Cella¹⁰, Lisa A Kottschade¹¹, Jane Perlmutter¹², Cindy Geoghegan¹³, Barbara Given¹⁴, Gina L Mazza⁴, Robert Miller¹⁵, Jon F Strasser¹⁶, Dylan M Zylla¹⁷, Anna Weiss¹⁸, Victoria S Blinder², Anna P Wolf¹⁹, Amylou C Dueck⁴

Affiliations

¹ University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA. ebasch@med.unc.edu.
² Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, NY, USA.
³ University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
⁴ Alliance and Data Management Center, Mayo Clinic, Scottsdale, AZ, USA.
⁵ Mayo Clinic, Division of Hematology, Rochester, MN, USA.
⁶ Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
⁷ Duke Cancer Institute, Duke University School of Medicine, Durham, NC, USA.
⁸ Johns Hopkins Schools of Medicine and Public Health, Baltimore, MD, USA.
⁹ Emory University, School of Nursing, Atlanta, GA, USA.
¹⁰ Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
¹¹ Mayo Clinic, Department of Medical Oncology, Rochester, MN, USA.
¹² Patient Representative, Gemini Group, Ann Arbor, MI, USA.
¹³ Patient Representative, Patient and Partners, Madison, CT, USA.
¹⁴ Michigan State University, College of Nursing, East Lansing, MI, USA.
¹⁵ American Society of Clinical Oncology, Alexandria, VA, USA.
¹⁶ Christiana Care Health Services, Wilmington, DE, USA.
¹⁷ HealthPartners Cancer Research Center, Minneapolis, MN, USA.
¹⁸ University of Rochester, Department of Surgery, Rochester, NY, USA.
¹⁹ Alliance for Clinical Trials in Oncology, Boston, MA, USA.

PMID: 39920394
PMCID: PMC12184200 (available on 2025-10-01)
DOI: 10.1038/s41591-025-03507-y

Randomized Controlled Trial

Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial

Ethan Basch et al. Nat Med. 2025 Apr.

. 2025 Apr;31(4):1225-1232.

doi: 10.1038/s41591-025-03507-y. Epub 2025 Feb 7.

Authors

Affiliations

¹ University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA. ebasch@med.unc.edu.
² Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, NY, USA.
³ University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
⁴ Alliance and Data Management Center, Mayo Clinic, Scottsdale, AZ, USA.
⁵ Mayo Clinic, Division of Hematology, Rochester, MN, USA.
⁶ Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
⁷ Duke Cancer Institute, Duke University School of Medicine, Durham, NC, USA.
⁸ Johns Hopkins Schools of Medicine and Public Health, Baltimore, MD, USA.
⁹ Emory University, School of Nursing, Atlanta, GA, USA.
¹⁰ Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
¹¹ Mayo Clinic, Department of Medical Oncology, Rochester, MN, USA.
¹² Patient Representative, Gemini Group, Ann Arbor, MI, USA.
¹³ Patient Representative, Patient and Partners, Madison, CT, USA.
¹⁴ Michigan State University, College of Nursing, East Lansing, MI, USA.
¹⁵ American Society of Clinical Oncology, Alexandria, VA, USA.
¹⁶ Christiana Care Health Services, Wilmington, DE, USA.
¹⁷ HealthPartners Cancer Research Center, Minneapolis, MN, USA.
¹⁸ University of Rochester, Department of Surgery, Rochester, NY, USA.
¹⁹ Alliance for Clinical Trials in Oncology, Boston, MA, USA.

PMID: 39920394
PMCID: PMC12184200 (available on 2025-10-01)
DOI: 10.1038/s41591-025-03507-y

Abstract

Symptoms are often underdetected during cancer treatment. To determine if symptom monitoring with electronic patient-reported outcomes (PROs) improves clinical outcomes, we conducted a cluster-randomized trial in which 52 oncology practices were assigned to PRO or usual care. At PRO practices, patients with metastatic cancer were invited to complete weekly symptom surveys. Severe or worsening symptoms generated alerts to the care team. The primary outcome was overall survival, and secondary outcomes included emergency visits, time to deterioration of physical function, symptoms, health-related quality of life (HRQL) and patient satisfaction with PRO. Among 1,191 enrolled patients, there was no difference in survival (hazard ratio (HR) 0.99 (95% confidence interval (CI), 0.83-1.17); P = 0.86). Time to first emergency visit was significantly prolonged with PRO compared to usual care (HR 0.84 ((95% CI, 0.71-0.98); P = 0.03), with a 6.1% reduction in the cumulative incidence of emergency visits and fewer mean visits at 12 months with PRO (1.02 versus 1.30; P < 0.001). Benefits also significantly favored PRO for delayed deterioration of physical function (median 12.6 versus 8.5 months, HR 0.73; P = 0.002), symptoms (12.7 versus 9.9, HR 0.69; P < 0.001) and HRQL (15.6 versus 12.2, HR 0.72; P = 0.001), which remained significant when considering deaths in analyses. Most patients felt that PRO improved discussions with the care team (77.0% (188/244)), made them feel more in control of their care (84.0% (205/244)) and would recommend it to other patients (91.4% (223/244)). Patients completed 91.5% (20,565/22,486) of expected weekly symptom surveys. These findings demonstrate that symptom monitoring with PRO meaningfully improves clinical outcomes, the patient experience and utilization of services and should be included as a standard part of quality cancer clinical care. Future studies of PRO in clinical care should focus on these outcomes rather than mortality as primary endpoints. ClinicalTrials.gov registration: NCT03249090.

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Conflict of interest statement

Competing interests: E.B. received personal fees from Navigating Cancer, AstraZeneca, Resilience, Thyme Care, N-Power Medicine, Verily and the Research Triangle Institute as a scientific advisor. D.S. received personal fees from Pfizer. A.M.S. received personal fees from UroGen Pharma and research funds to her institution from Pfizer Global. P.A.S. received personal fees from Pfizer. G.T. received research funds to her institution from Seagen and Novartis. C.S. received personal fees from Shionogi and Movember and research funds to her institution from Pfizer and Genentech. R.M. is employed by ConcertAI and received meal reimbursements from AstraZeneca. D.C. is the president of FACIT.org and an uncompensated board member of the PROMIS Health Organization. L.A.K. received research funds to her institution from Immunocore. A.W. received personal fees from Merck. The other authors declare no competing interests.

References

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Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial

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Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial

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Conflict of interest statement

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