Breast Cancer Clinical Trial
Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Female
Age 15-39 years at diagnosis of a stage 0-III breast cancer
Within 3 years of breast cancer diagnosis
No known evidence of breast cancer recurrence (local or distant) or second primary breast cancer
No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)
Able to speak, understand and read English
Cognitively able to complete the study requirements
Ability to access medical records from treating hospital
Willing to provide cell phone number and/or email address, and willing to receive email and/or text messages from the study team either with their own smartphone or one provided by the study team if they do not have their own to use
Pregnant survivors are also eligible for this protocol, given that fertility and pregnancy are important AYA issues
Exclusion Criteria:
Individuals under age 15 or over age 42
Stage IV or metastatic breast cancer
Males with breast cancer are not being recruited to this protocol. In the AYA age group, only a miniscule proportion of breast cancers occur in males. For this reason, the YES portal intervention materials have been targeted for young women
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There are 3 Locations for this study
Boston Massachusetts, 02215, United States More Info
Principal Investigator
Columbus Ohio, 43210, United States More Info
Principal Investigator
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