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

January 10, 2025 updated by: Alliance Foundation Trials, LLC.

"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

Completed

Conditions

Intervention / Treatment

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)

1197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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
Time Frame: 24 months
Unadjusted Kaplan-Meier estimated survival, based on administrative datasets and practice self-report/medical records.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Functioning
Time Frame: Month 3

Physical functioning was measured at the 3 month time point using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. The QLQ-C30 is a widely used 30 item questionnaire with excellent measurement properties. Physical functioning was assessed via 5 items from the QLQ-C30 which generated a single score on a 0-100 point scale (higher scores are better).

Mean changes from baseline were measured using the QLQ-C30 at 3 months and compared between arms with a linear combination of parameters from a general linear mixed model. Patients who completed the QLQ C30 at baseline and each follow up time point were categorized as improved on each outcome if their score increased by >/=5 points from baseline; worse if their score decreased by >/=5 points and otherwise as stable.
Month 3
Symptom Control
Time Frame: Month 3

Symptom control was measured at the 3 month time point using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. The QLQ-C30 is a widely used 30 item questionnaire with excellent measurement properties. Symptom control was assessed as a composite of 8 QLQ-C30 symptom scale scores on a 0-100 point scale (higher scores are better).

Mean changes from baseline were measured using the QLQ-C30 at 3 months and compared between arms with a linear combination of parameters from a general linear mixed model. Patients who completed the QLQ C30 at baseline and each follow up time point were categorized as improved on each outcome if their score increased by >/=5 points from baseline; worse if their score decreased by >/=5 points and otherwise as stable.
Month 3
Health-related Quality of Life
Time Frame: Month 3

Health-related quality of life was measured at the 3 month time point using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. The QLQ-C30 is a widely used 30 item questionnaire with excellent measurement properties. Health-related quality of life was assessed as a composite of function and symptom scale scores on a 0-100 point scale (higher scores are better).

Mean changes from baseline were measured using the QLQ-C30 at 3 months and compared between arms with a linear combination of parameters from a general linear mixed model. Patients who completed the QLQ C30 at baseline and each follow up time point were categorized as improved on each outcome if their score increased by >/=5 points from baseline; worse if their score decreased by >/=5 points and otherwise as stable.
Month 3
Patient Satisfaction/Communication
Time Frame: Month 3
Patients in the ePRO arm were measured via Patient Satisfaction Questionnaire assessing comprehension of ePRO questions, usability of digital ePRO system, meaningfulness/relevance of ePRO questions, communication/actionability with care team, clinical utility of ePRO system and patient self efficacy. The number of patients analyzed is the number of patients who completed the questions. Some questions were not administered to all patients.
Month 3
Emergency Department Utilization
Time Frame: 1 year
Data for emergency department visits were obtained from data abstracted at each practice from the electronic medical record.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

August 30, 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)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Cancer

Clinical Trials on Patient Self-Reporting of Symptoms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe