Electronic Patient Reporting of Symptoms During Cancer Treatment
NCT ID: NCT03249090
Last Updated: 2025-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1197 participants
INTERVENTIONAL
2017-10-30
2023-08-30
Brief Summary
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Detailed Description
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PROCEDURES AT ALL SITES (CONTROL SITES AND INTERVENTION SITES):
* Site staff (CRA and Nurse Champion required) will attend the site initiation webinar with UNC staff, including training for the PRO-Core online data management system and orientation to the symptom management guidelines.
* At enrollment, all participants will be given a booklet with patient-level symptom advice and a link to the content online.
* All participants will receive compensation for participation, mailed to them as gift cards by UNC.
* CRAs will train all participants how to complete outcomes questionnaires for the trial using the PRO-Core online system. Participants will be given a choice to complete these in clinic or from home online, or if necessary via paper in clinic (with the CRA entering the data into PRO-Core). If the patient does not self-complete this information, the CRA will contact them to collect the information and then enter it into PRO-Core. The outcomes questionnaires will be completed at baseline; and at month 1 (+/- 2 weeks); and at months 3, 6, 9, and 12/off-study (+/- 4 weeks each), and will be available in English, Spanish, or Mandarin Chinese. At each time point, the CRA will contact the participant to remind them about the upcoming questionnaire and offer help.
* Chart abstraction will be conducted by CRAs at baseline and at off-study for each participant, with data entered into the PRO-Core system. Date of death information will additionally be abstracted at 18 and 24 months, and possibly later per the UNC study team.
* CRAs will be asked to complete a feedback survey (entered by the CRA into the PRO-Core online system) and may be asked to participate in a brief telephone debriefing and/or site visit.
* Accrual will be monitored in a weekly teleconference between the UNC team and site CRAs.
ADDITIONAL PROCEDURES AT INTERVENTION SITES ONLY:
* At baseline, CRAs will also train patients to self-report symptoms and physical functioning using the PRO-Core system weekly for up to a year, with a choice to do this online or via an automated telephone system (patient choice), and a choice of English, Spanish, or Mandarin Chinese.
* Whenever a concerning symptom is reported, an automated "email alert" notification will be sent to the site CRA. The CRA will forward the email 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Patient Self-Reporting of Symptoms
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.
Patient Self-Reporting of Symptoms
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.
Usual Care Delivery
Evidence-based symptom management pathways provided to patients and clinicians
Usual Care Delivery
Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
Interventions
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Patient Self-Reporting of Symptoms
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.
Usual Care Delivery
Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
Eligibility Criteria
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Inclusion Criteria
2. Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy.
3. 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.
4. Can understand English, Spanish, and/or Mandarin Chinese.
Exclusion Criteria
2. Current participation in a therapeutic clinical trial (because these often involve PRO questionnaires and intensive monitoring).
3. Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).
4. Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast cancer; androgen deprivation therapy in prostate cancer; or octreotide in neuroendocrine cancers)
5. Indolent lymphomas (due to their prolonged time courses that may be minimally symptomatic).
6. Leukemias (time courses inconsistent with other tumor types in chronic and acute leukemias).
7. Does not understand English, Spanish, or Mandarin Chinese.
21 Years
ALL
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of North Carolina
OTHER
Mayo Clinic
OTHER
American Society of Clinical Oncology
OTHER
American Cancer Society, Inc.
OTHER
Dana-Farber Cancer Institute
OTHER
Alliance Foundation Trials, LLC.
OTHER
Responsible Party
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Principal Investigators
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Ethan Basch, MD
Role: STUDY_CHAIR
University of North Carolina, Chapel Hill
Locations
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Grand Valley Oncology
Grand Junction, Colorado, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Quincy Medical Group
Quincy, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Union Hospital
Terre Haute, Indiana, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Meritus Medical Center
Hagerstown, Maryland, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Joseph Mercy Ann Arbor Hospital
Ypsilanti, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
Springfield, Missouri, United States
Cox Medical Center South
Springfield, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Nevada Cancer Specialists
Las Vegas, Nevada, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States
Montefiore Medical Center/ Albert Einstein College of Medicine
The Bronx, New York, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Rex Cancer Center
Raleigh, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
WellSpan Health - York Cancer Center
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
MD Anderson Cancer Center
Houston, Texas, United States
Centra Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Saint Vincent Hospital Cancer Center
Green Bay, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AFT-39
Identifier Type: -
Identifier Source: org_study_id
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