Electronic Patient Reporting of Symptoms During Cancer Treatment

NCT03249090 | Completed Results

• 1 other identifier: AFT-39
• Study Type: interventional
• Target: 1,197
• Locations: 1 country
• Sites: 45

Brief Summary

The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Unadjusted Kaplan-Meier estimated survival, based on administrative datasets and practice self-report/medical records.

  24 months

Secondary Outcomes (5)

• Physical Functioning

  Month 3

• Symptom Control

  Month 3

• Health-related Quality of Life

  Month 3

• Patient Satisfaction/Communication

  Month 3

• Emergency Department Utilization

  1 year

Study Arms (2)

Patient Self-Reporting of Symptoms

EXPERIMENTAL

Patients report symptoms weekly via web or automated telephone system. Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.

Other: Patient Self-Reporting of Symptoms

Usual Care Delivery

ACTIVE COMPARATOR

Evidence-based symptom management pathways provided to patients and clinicians

Other: Usual Care Delivery

Interventions

Patient Self-Reporting of Symptoms OTHER

At baseline, CRAs will train patients to self-report symptoms and physical functioning weekly for up to a year, with a choice to do so online or via an automated telephone system. Whenever a concerning symptom is reported, an automated "email alert" notification will be sent to the site CRA. The CRA will forward the alert to the responsible clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72 hours, the CRA will document what action(s), if any, were taken by the nurse in response to the alert (entered by the CRA into a form in the PRO-Core system). A symptom report will be printed/generated by the site CRA whenever the patient has a clinic visit and will be given to the oncologist and nurse caring for the patient.

Patient Self-Reporting of Symptoms

Usual Care Delivery OTHER

Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms

Usual Care Delivery

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (21+) with metastatic cancer of any type (EXCEPT leukemia or indolent \[slow growing\] lymphoma)
• Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy.
• Enrolled at any point in their treatment trajectory, meaning during any line of treatment, and at any point during a course or cycle of treatment.
• Can understand English, Spanish, and/or Mandarin Chinese.

You may not qualify if:

• Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
• Current participation in a therapeutic clinical trial (because these often involve PRO questionnaires and intensive monitoring).
• Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).
• Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast cancer; androgen deprivation therapy in prostate cancer; or octreotide in neuroendocrine cancers)
• Indolent lymphomas (due to their prolonged time courses that may be minimally symptomatic).
• Leukemias (time courses inconsistent with other tumor types in chronic and acute leukemias).
• Does not understand English, Spanish, or Mandarin Chinese.

Sponsors & Collaborators

• Alliance Foundation Trials, LLC.: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of North Carolina: collaborator
• Mayo Clinic: collaborator
• American Society of Clinical Oncology: collaborator
• American Cancer Society, Inc.: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (45)

Grand Valley Oncology

Grand Junction, Colorado, 81505, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30046, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Quincy Medical Group

Quincy, Illinois, 62301, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Union Hospital

Terre Haute, Indiana, 47804, United States

Location

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, 52722, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Meritus Medical Center

Hagerstown, Maryland, 21742, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. Joseph Mercy Ann Arbor Hospital

Ypsilanti, Michigan, 48197, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55426, United States

Location

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

Springfield, Missouri, 65804, United States

Location

Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Nevada Cancer Specialists

Las Vegas, Nevada, 89102, United States

Location

New Hampshire Oncology Hematology PA-Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Montefiore Medical Center/ Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28304, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Rex Cancer Center

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Columbus NCI Community Oncology Research Program

Columbus, Ohio, 43215, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

WellSpan Health - York Cancer Center

York, Pennsylvania, 17403, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Centra Lynchburg Hematology Oncology Clinic

Lynchburg, Virginia, 24501, United States

Location

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States

Location

Saint Vincent Hospital Cancer Center

Green Bay, Wisconsin, 54301, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (15)

• Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3. No abstract available.

  PMID: 23822654 BACKGROUND

• Reilly CM, Bruner DW, Mitchell SA, Minasian LM, Basch E, Dueck AC, Cella D, Reeve BB. A literature synthesis of symptom prevalence and severity in persons receiving active cancer treatment. Support Care Cancer. 2013 Jun;21(6):1525-50. doi: 10.1007/s00520-012-1688-0. Epub 2013 Jan 12.

  PMID: 23314601 BACKGROUND

• Henry DH, Viswanathan HN, Elkin EP, Traina S, Wade S, Cella D. Symptoms and treatment burden associated with cancer treatment: results from a cross-sectional national survey in the U.S. Support Care Cancer. 2008 Jul;16(7):791-801. doi: 10.1007/s00520-007-0380-2. Epub 2008 Jan 17.

  PMID: 18204940 BACKGROUND

• Cleeland CS, Zhao F, Chang VT, Sloan JA, O'Mara AM, Gilman PB, Weiss M, Mendoza TR, Lee JW, Fisch MJ. The symptom burden of cancer: Evidence for a core set of cancer-related and treatment-related symptoms from the Eastern Cooperative Oncology Group Symptom Outcomes and Practice Patterns study. Cancer. 2013 Dec 15;119(24):4333-40. doi: 10.1002/cncr.28376. Epub 2013 Sep 24.

  PMID: 24114037 BACKGROUND

• Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004 Sep 1;22(17):3485-90. doi: 10.1200/JCO.2004.03.025.

  PMID: 15337796 BACKGROUND

• Laugsand EA, Sprangers MA, Bjordal K, Skorpen F, Kaasa S, Klepstad P. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes. 2010 Sep 21;8:104. doi: 10.1186/1477-7525-8-104.

  PMID: 20858248 BACKGROUND

• Atkinson TM, Li Y, Coffey CW, Sit L, Shaw M, Lavene D, Bennett AV, Fruscione M, Rogak L, Hay J, Gonen M, Schrag D, Basch E. Reliability of adverse symptom event reporting by clinicians. Qual Life Res. 2012 Sep;21(7):1159-64. doi: 10.1007/s11136-011-0031-4. Epub 2011 Oct 8.

  PMID: 21984468 BACKGROUND

• Fung CH, Hays RD. Prospects and challenges in using patient-reported outcomes in clinical practice. Qual Life Res. 2008 Dec;17(10):1297-302. doi: 10.1007/s11136-008-9379-5. Epub 2008 Aug 18.

  PMID: 18709564 BACKGROUND

• Conway PH, Mostashari F, Clancy C. The future of quality measurement for improvement and accountability. JAMA. 2013 Jun 5;309(21):2215-6. doi: 10.1001/jama.2013.4929. No abstract available.

  PMID: 23736730 BACKGROUND

• Stover AM, Deal AM, Ginos B, Dueck A, Spears PA, Jansen J, Carr P, Henson S, Bennett AV, Jonsson M, Snyder C, Basch E. Impact of Providing an Automated Telephone Option to Report Weekly Patient-Reported Outcome Measures in the PRO-TECT Trial (AFT-39) on Disparity Gaps in Symptom Management and Outcomes. JCO Clin Cancer Inform. 2025 May;9:e2500046. doi: 10.1200/CCI-25-00046. Epub 2025 May 23.

  PMID: 40408610 DERIVED

• Mody GN, Bennett AV, Stover AM, Jonsson M, Teal R, Vu M, Carda-Auten J, Jansen J, Carr P, Dueck A, Henson S, Basch E. Implementation of Symptom Monitoring With Electronic Patient-Reported Outcomes: Perspectives and Recommendations From Community Oncology Practices (Alliance AFT-39). JCO Oncol Pract. 2025 Dec;21(12):1830-1837. doi: 10.1200/OP-24-00627. Epub 2025 Apr 11.

  PMID: 40215451 DERIVED

• Basch E, Schrag D, Jansen J, Henson S, Ginos B, Stover AM, Carr P, Spears PA, Jonsson M, Deal AM, Bennett AV, Thanarajasingam G, Rogak L, Reeve BB, Snyder C, Bruner D, Cella D, Kottschade LA, Perlmutter J, Geoghegan C, Given B, Mazza GL, Miller R, Strasser JF, Zylla DM, Weiss A, Blinder VS, Wolf AP, Dueck AC. Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial. Nat Med. 2025 Apr;31(4):1225-1232. doi: 10.1038/s41591-025-03507-y. Epub 2025 Feb 7.

  PMID: 39920394 DERIVED

• Lee MK, Mitchell SA, Basch E, Mazza GL, Langlais BT, Thanarajasingam G, Ginos BF, Rogak L, Meek EA, Jansen J, Deal AM, Carr P, Blinder VS, Jonsson M, Mody GN, Mendoza TR, Bennett AV, Schrag D, Dueck AC. Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE(R)). Qual Life Res. 2025 Feb;34(2):495-507. doi: 10.1007/s11136-024-03819-5. Epub 2024 Nov 6.

  PMID: 39503942 DERIVED

• Basch E, Schrag D, Henson S, Jansen J, Ginos B, Stover AM, Carr P, Spears PA, Jonsson M, Deal AM, Bennett AV, Thanarajasingam G, Rogak LJ, Reeve BB, Snyder C, Bruner D, Cella D, Kottschade LA, Perlmutter J, Geoghegan C, Samuel-Ryals CA, Given B, Mazza GL, Miller R, Strasser JF, Zylla DM, Weiss A, Blinder VS, Dueck AC. Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial. JAMA. 2022 Jun 28;327(24):2413-2422. doi: 10.1001/jama.2022.9265.

  PMID: 35661856 DERIVED

• Basch E, Stover AM, Schrag D, Chung A, Jansen J, Henson S, Carr P, Ginos B, Deal A, Spears PA, Jonsson M, Bennett AV, Mody G, Thanarajasingam G, Rogak LJ, Reeve BB, Snyder C, Kottschade LA, Charlot M, Weiss A, Bruner D, Dueck AC. Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial. JCO Clin Cancer Inform. 2020 Oct;4:947-957. doi: 10.1200/CCI.20.00081.

  PMID: 33112661 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was conducted during the pandemic when research and clinical resources at participating sites were strained with frequent turnover of staff. This disrupted accrual and conduct and likely decreased the effect size observed.

Results Point of Contact

• Title: Principal Investigator
• Organization: University of North Carolina at Chapel Hill

symptom_study@unc.edu

9194456223

Study Officials

• Ethan Basch, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 15, 2017
• Study Start: October 30, 2017
• Primary Completion: March 30, 2022
• Study Completion: August 30, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (45)