Spots Global Cancer Trial Database for Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
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Trial Identification
Brief Title: Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
Official Title: Randomized Controlled Trial of Young, Empowered &Amp; Strong (YES), a Web-Based Patient-Reported Symptom Monitoring and Self-Management Portal for Adolescent and Young Adult Breast Cancer Survivors
Study ID: NCT04906200
Conditions
Study Description
Brief Summary: This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, Young, Empowered \& Strong (YES), to standard therapy in managing symptoms in adolescent and young adults breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. YES portal may improve the quality of life of young breast cancer survivors. YES portal may help manage symptoms and provide useful information/resources.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the efficacy of the YES intervention compared to usual care in improving quality of life (QOL), as measured by the Quality of Life in Adult Cancer Survivors (QLACS) at 6-months (primary outcome). II. To determine the efficacy of the YES intervention compared to usual care in reducing specific adolescent and young adult (AYA) breast cancer (BC) concerns and symptoms at 6-months. III. To determine the sustainability of the effects of YES on AYA concerns, symptoms, and QOL at 9 months, after the completion of the 6-month active intervention period. EXPLORATORY OBJECTIVE: I. To explore potential moderators and mediators of intervention efficacy, and to explore the potential effects of the intervention on inflammatory and other biomarkers including genetic profiles. OUTLINE: Patients are randomized to 1 to 2 groups. GROUP A: Patients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. GROUP B: Patients receive usual care for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. After 9 months, patients may also receive access to YES portal for 3 months.
Keywords
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Columbia University Medical Center, New York, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Contact Details
Name: Michelle Naughton, PhD
Affiliation: Ohio State University Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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