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

The Ohio State University

Status: Active, not recruiting

Conditions: Anatomic Stage III Breast Cancer AJCC V8; Anatomic Stage IIIA Breast Cancer AJCC V8; Prognostic Stage IA Breast Cancer AJCC V8; Anatomic Stage IB Breast Cancer AJCC V8; Prognostic Stage IIA Breast Cancer AJCC V8; Prognostic Stage I Breast Cancer AJCC V8; Prognostic Stage IIIC Breast Cancer AJCC V8; Prognostic Stage II 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; Anatomic Stage IIA Breast Cancer AJCC V8; Anatomic Stage IA Breast Cancer AJCC V8; Prognostic Stage IB Breast Cancer AJCC V8; Anatomic Stage IIB Breast Cancer AJCC V8; Anatomic Stage IIIB Breast Cancer AJCC V8; Anatomic Stage II Breast Cancer AJCC V8; Prognostic Stage IIIB Breast Cancer AJCC V8; Prognostic Stage 0 Breast Cancer AJCC V8; Anatomic Stage 0 Breast Cancer AJCC V8; Anatomic Stage I Breast Cancer AJCC V8; Anatomic Stage IIIC Breast Cancer AJCC V8

Treatments: Other: Internet-Based Intervention; Other: Best Practice; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04906200

U01CA246648 (U.S. NIH Grant/Contract)

OSU-21035

NCI-2021-03962 (Registry Identifier)

Details and patient eligibility

About

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.

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 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 15 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Group A (YES portal)

Experimental group

Description:

Patients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.

Treatment:

Other: Survey Administration

Other: Internet-Based Intervention

Group B (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Best Practice