Clinical trial NCT04906200: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anatomic Stage 0 Breast Cancer AJCC V8
Anatomic Stage I Breast Cancer AJCC V8
Anatomic Stage IA Breast Cancer AJCC V8
Anatomic Stage IB Breast Cancer AJCC V8
Anatomic Stage II Breast Cancer AJCC V8
Anatomic Stage IIA Breast Cancer AJCC V8
Anatomic Stage IIB Breast Cancer AJCC V8
Anatomic Stage III Breast Cancer AJCC V8
Anatomic Stage IIIA Breast Cancer AJCC V8
Anatomic Stage IIIB Breast Cancer AJCC V8
Anatomic Stage IIIC Breast Cancer AJCC V8
Prognostic Stage 0 Breast Cancer AJCC V8
Prognostic Stage I Breast Cancer AJCC V8
Prognostic Stage IA Breast Cancer AJCC V8
Prognostic Stage IB Breast Cancer AJCC V8
Prognostic Stage II Breast Cancer AJCC V8
Prognostic Stage IIA Breast Cancer AJCC V8
Prognostic Stage IIB Breast Cancer AJCC V8
Prognostic Stage III Breast Cancer AJCC V8
Prognostic Stage IIIA Breast Cancer AJCC V8
Prognostic Stage IIIB Breast Cancer AJCC V8
Prognostic Stage IIIC Breast Cancer AJCC V8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dana-Farber Cancer Institute
name: Columbia University
First posted: 2021-05-28
Enrollment: 400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
timeFrame: Up to 6 months
Secondary outcomes:
measure: 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.
timeFrame: Up to 6 months
measure: Sustainability of the effects of YES on AYA concerns and symptoms
timeFrame: Up to 9 months post-baseline, after the completion of the 6-month active intervention period
measure: Quality of Life (QOL)
timeFrame: Up to 9 months
Other outcomes:
measure: Potential effects of the intervention on inflammatory and other biomarkers and genetic profiles
timeFrame: Baseline and 6 months
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: New York City
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Michelle Naughton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.