Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
YES
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
3 other identifiers
interventional
400
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
June 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 19, 2026
February 1, 2026
5.5 years
May 13, 2021
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
Will determine the efficacy of the YES intervention compared to usual care in improving QOL, as measured by the Quality of Life in Adult Cancer Survivors Scale at 6-months (primary outcome). The QLACS contains 47 items scored on a 1 (never) to 7 (always) scale. The 47 items are grouped into 12 domains (7 generic and 5 cancer-specific). A QLACS generic summary score is calculated by adding the 7 constituent domain scores, so that a lower score (range: 31-143) corresponds to higher QOL. A QLACS cancer-specific summary score (range: 16-99) is calculated by adding the constituent domain scores of all but the "benefits" domain. The benefits domain is scored separately (range: 4-28).
Up to 6 months
Secondary Outcomes (3)
Efficacy of the YES intervention in reducing specific adolescent and young adult (AYA) breast confident (BC) concerns and symptoms at 6-months compared to baseline.
Up to 6 months
Sustainability of the effects of YES on AYA concerns and symptoms
Up to 9 months post-baseline, after the completion of the 6-month active intervention period
Quality of Life (QOL)
Up to 9 months
Other Outcomes (1)
Potential effects of the intervention on inflammatory and other biomarkers and genetic profiles
Baseline and 6 months
Study Arms (2)
Group A (YES portal)
EXPERIMENTALPatients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.
Group B (usual care)
ACTIVE COMPARATORPatients 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.
Interventions
Receive usual care
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Ohio State University Comprehensive Cancer Centerlead
- Dana-Farber Cancer Institutecollaborator
- Columbia Universitycollaborator
Study Sites (3)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Columbia University Medical Center
New York, New York, 10032, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Dibble KE, Rosenberg SM, Snow C, Kirkner GJ, Tayob N, Contreras M, Roma ND, DeGraffinreid CR, Nolan TS, Hershman DL, Naughton M, Partridge AH. Young, Empowered & strong (YES): a study protocol paper for a randomized controlled trial of an mHealth symptom monitoring and self-management intervention for adolescent and young adult (AYA) breast cancer survivors. BMC Public Health. 2025 Jan 11;25(1):126. doi: 10.1186/s12889-025-21288-4.
PMID: 39799291BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Naughton, PhD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 13, 2021
First Posted
May 28, 2021
Study Start
June 28, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share