Electronic Patient Reporting of Symptoms During Cancer Treatment

Metastatic Cancer Clinical Trial

— PRO-TECT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03249090
• Other study ID #: AFT-39
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: August 2023

Study information

• Verified date: November 2021
• Source: Alliance Foundation Trials, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1191
• Est. completion date: August 2023
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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.
• Usual Care Delivery
Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	University of Iowa Healthcare Cancer Services Quad Cities	Bettendorf	Iowa
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Bozeman Health Deaconess Hospital	Bozeman	Montana
United States	Montefiore Medical Center/ Albert Einstein College of Medicine	Bronx	New York
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	Columbus NCI Community Oncology Research Program	Columbus	Ohio
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	Hematology Oncology Associates of Central New York	East Syracuse	New York
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Grand Valley Oncology	Grand Junction	Colorado
United States	Saint Vincent Hospital Cancer Center	Green Bay	Wisconsin
United States	East Carolina University	Greenville	North Carolina
United States	Meritus Medical Center	Hagerstown	Maryland
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	New Hampshire Oncology Hematology PA-Hooksett	Hooksett	New Hampshire
United States	MD Anderson Cancer Center	Houston	Texas
United States	Edwards Comprehensive Cancer Center	Huntington	West Virginia
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
United States	Nevada Cancer Specialists	Las Vegas	Nevada
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Centra Lynchburg Hematology Oncology Clinic	Lynchburg	Virginia
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Quincy Medical Group	Quincy	Illinois
United States	Rex Cancer Center	Raleigh	North Carolina
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic	Rochester	Minnesota
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Cox Medical Center South	Springfield	Missouri
United States	Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center	Springfield	Missouri
United States	Union Hospital	Terre Haute	Indiana
United States	Carle Cancer Center	Urbana	Illinois
United States	Wake Forest University	Winston-Salem	North Carolina
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	WellSpan Health - York Cancer Center	York	Pennsylvania
United States	St. Joseph Mercy Ann Arbor Hospital	Ypsilanti	Michigan

Sponsors (7)

Lead Sponsor	Collaborator
Alliance Foundation Trials, LLC.	American Cancer Society, Inc., American Society of Clinical Oncology, Dana-Farber Cancer Institute, Mayo Clinic, Patient-Centered Outcomes Research Institute, University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (9)

Atkinson TM, Li Y, Coffey CW, Sit L, Shaw M, Lavene D, Bennett AV, Fruscione M, Rogak L, Hay J, Gönen 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Based on administrative datasets and practice self-report/medical records.	24 months
Secondary	Physical Functioning	Physical functioning will be measured via the QLQ-C30	month 3
Secondary	Symptom Control	Measured via the QLQ-C30	month 3
Secondary	Health-related quality of life and symptom burden time	Measured by QLQ-C30	month 3
Secondary	Patient Satisfaction/Communication	Measured via Patient Satisfaction Questionnaires	month 3
Secondary	Emergency room/hospital utilization	Based on practice self-report/medical records and/or administrative datasets	1 year