Trials / Active Not Recruiting

Active Not RecruitingNCT04906200

Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors

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

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 400 (estimated)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: Female
Age: 15 Years – 39 Years
Healthy volunteers: Not accepted

Summary

This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, the Young, Empowered \& Strong (YES), to standard therapy in managing symptoms in adolescent and young adult breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. The YES portal may improve the quality of life of young breast cancer survivors. The 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 of 2 groups. GROUP A: Patients receive access to the 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 the YES portal for 3 months.

Conditions

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Internet-Based Intervention	Receive access to YES portal
OTHER	Survey Administration	Complete survey

Timeline

Start date: 2021-06-28
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2021-05-28
Last updated: 2026-02-19

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04906200. Inclusion in this directory is not an endorsement.