Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
NCT ID: NCT04906200
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
400 participants
INTERVENTIONAL
2021-06-28
2026-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A (YES portal)
Patients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.
Internet-Based Intervention
Receive access to YES portal
Survey Administration
Complete survey
Group B (usual care)
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.
Best Practice
Receive usual care
Survey Administration
Complete survey
Interventions
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Best Practice
Receive usual care
Internet-Based Intervention
Receive access to YES portal
Survey Administration
Complete survey
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
39 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Columbia University
OTHER
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Michelle Naughton
Principal Investigator
Principal Investigators
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Michelle Naughton, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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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
Countries
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References
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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.
Related Links
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The Jamesline
Other Identifiers
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NCI-2021-03962
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-21035
Identifier Type: -
Identifier Source: org_study_id
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