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Spots Global Cancer Trial Database for Electronic Patient Reporting of Symptoms During Cancer Treatment

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Electronic Patient Reporting of Symptoms During Cancer Treatment

Official Title: "PRO-TECT" Patient Reported Outcomes to Enhance Cancer Treatment

Study ID: NCT03249090

Study Description

Brief 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.

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.

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

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

Missouri Baptist Medical Center, Saint Louis, Missouri, United States

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center, Springfield, Missouri, United States

Cox Medical Center South, Springfield, 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

Montefiore Medical Center/ Albert Einstein College of Medicine, Bronx, New York, 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

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

Contact Details

Name: Ethan Basch, MD

Affiliation: University of North Carolina, Chapel Hill

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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