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Metastatic CancerPRO-TECTNCT03249090

Electronic Patient Reporting of Symptoms During Cancer Treatment

A study testing Patient Self-Reporting of Symptoms in people with Metastatic Cancer, run by Alliance Foundation Trials, LLC. at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Metastatic Cancer
What is being tested?
Patient Self-Reporting of Symptoms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,197 participants
Where
45 sitesUnited States
Study dates
30 Oct 2017to 30 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28304

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505

  • Saint Vincent Hospital Cancer Center

    Green Bay, Wisconsin, 54301

  • East Carolina University

    Greenville, North Carolina, 27858

  • Meritus Medical Center

    Hagerstown, Maryland, 21742

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • New Hampshire Oncology Hematology PA-Hooksett

    Hooksett, New Hampshire, 03106

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • Nevada Cancer Specialists

    Las Vegas, Nevada, 89102

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30046

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Centra Lynchburg Hematology Oncology Clinic

    Lynchburg, Virginia, 24501

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Rex Cancer Center

    Raleigh, North Carolina, 27607

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55426

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

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

    Springfield, Missouri, 65804

  • Cox Medical Center South

    Springfield, Missouri, 65807

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Union Hospital

    Terre Haute, Indiana, 47804

  • Montefiore Medical Center/ Albert Einstein College of Medicine

    The Bronx, New York, 10467

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health - York Cancer Center

    York, Pennsylvania, 17403

  • St. Joseph Mercy Ann Arbor Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: "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.

Read the 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.
Being tested
Patient Self-Reporting of Symptoms, Usual Care Delivery
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Self-Reporting of SymptomsOther

    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 DeliveryOther

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

Study groups in NCT03249090
Study groupRoleWhat they receive
Patient Self-Reporting of SymptomsExperimentalPatients 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.
Receives: Other: Patient Self-Reporting of Symptoms
Usual Care DeliveryActive comparatorEvidence-based symptom management pathways provided to patients and clinicians
Receives: Other: Usual Care Delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

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

    Measured: 24 months

Secondary outcomes (5)

  1. Physical Functioning

    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.

    Measured: Month 3

  2. Symptom Control

    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.

    Measured: Month 3

  3. Health-related Quality of Life

    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.

    Measured: Month 3

  4. Patient Satisfaction/Communication

    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.

    Measured: Month 3

  5. Emergency Department Utilization

    Data for emergency department visits were obtained from data abstracted at each practice from the electronic medical record.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start30 Oct 2017
  3. Primary completion30 Mar 2022
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249090
Sponsor's protocol ID
AFT-39
Acronym
PRO-TECT
Status last verified
Jan 2024
First submitted
1 Aug 2017
Last updated
14 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23822654

  • 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.

    PubMed 23314601

  • 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.

    PubMed 18204940

  • 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.

    PubMed 24114037

  • 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.

    PubMed 15337796

  • 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.

    PubMed 20858248

  • 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.

    PubMed 21984468

  • 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.

    PubMed 18709564

  • 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.

    PubMed 23736730

  • 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.

    PubMed 40408610

  • 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.

    PubMed 40215451

  • 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.

    PubMed 39920394

  • 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.

    PubMed 39503942

  • 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.

    PubMed 35661856

  • 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.

    PubMed 33112661

Questions about this trial

What is this clinical trial studying?

A study testing Patient Self-Reporting of Symptoms in people with Metastatic Cancer, run by Alliance Foundation Trials, LLC. at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03249090, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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