Electronic Patient Reporting of Symptoms During Cancer Treatment (PRO-TECT)

"PRO-TECT" Patient Reported Outcomes to Enhance Cancer Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Cancer
• Intervention / Treatment: Other: Patient Self-Reporting of Symptoms; Other: Usual Care Delivery

Detailed Description

This is a cluster RCT at approximately 50 sites where randomization will occur in a 1:1 ratio at the site level (not at the individual patient level). Therefore, approximately 25 sites will be randomized to the PRO-TECT intervention arm (patient-reporting of symptoms), and approximately 25 sites will be randomized to the control arm (usual care delivery). Approximately 1200 patients will be enrolled. Specifically:

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.

• Study Type: Interventional
• Enrollment (Actual): 1191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Grand Junction, Colorado, United States, 81505
      • Grand Valley Oncology
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Medical Center
  • Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare-Peoria
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health Indianapolis
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
    • Terre Haute, Indiana, United States, 47804
      • Union Hospital
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • University of Iowa Healthcare Cancer Services Quad Cities
    • Cedar Rapids, Iowa, United States, 52403
      • Oncology Associates at Mercy Medical Center
    • Des Moines, Iowa, United States, 50309
      • Medical Oncology and Hematology Associates-Des Moines
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
    • Hagerstown, Maryland, United States, 21742
      • Meritus Medical Center
  • Massachusetts
    • Lowell, Massachusetts, United States, 01854
      • Lowell General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Ann Arbor Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Louis Park, Minnesota, United States, 55426
      • Metro Minnesota Community Oncology Research Consortium
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • Springfield, Missouri, United States, 65807
      • Cox Medical Center South
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
    • Bozeman, Montana, United States, 59715
      • Bozeman Health Deaconess Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Nevada Cancer Specialists
  • New Hampshire
    • Hooksett, New Hampshire, United States, 03106
      • New Hampshire Oncology Hematology PA-Hooksett
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center/ Albert Einstein College of Medicine
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Cape Fear Valley Health System
    • Greenville, North Carolina, United States, 27858
      • East Carolina University
    • Raleigh, North Carolina, United States, 27607
      • Rex Cancer Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Columbus NCI Community Oncology Research Program
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
    • York, Pennsylvania, United States, 17403
      • Wellspan Health - York Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Lynchburg Hematology Oncology Clinic
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Edwards Comprehensive Cancer Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital Cancer Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults (21+) with metastatic cancer of any type (EXCEPT leukemia or indolent [slow growing] lymphoma)
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:

1. Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: 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.
ACTIVE_COMPARATOR: Usual Care Delivery; Evidence-based symptom management pathways provided to patients and clinicians	Other: Usual Care Delivery; Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Based on administrative datasets and practice self-report/medical records.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Functioning	Physical functioning will be measured via the QLQ-C30	month 3
Symptom Control	Measured via the QLQ-C30	month 3
Health-related quality of life and symptom burden time	Measured by QLQ-C30	month 3
Patient Satisfaction/Communication	Measured via Patient Satisfaction Questionnaires	month 3
Emergency room/hospital utilization	Based on practice self-report/medical records and/or administrative datasets	1 year

Collaborators and Investigators

• Sponsor: Alliance Foundation Trials, LLC.
• Collaborators: Patient-Centered Outcomes Research Institute; Mayo Clinic; Dana-Farber Cancer Institute; American Cancer Society, Inc.; American Society of Clinical Oncology; University of North Carolina
• Investigators: Study Chair: Ethan Basch, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2017
• Primary Completion (ACTUAL): March 30, 2022
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: AFT-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No