Randomized controlled trial of Young, Empowered & Strong (YES), a web-based patient-reported symptom monitoring and self-management portal for adolescent and young adult breast cancer survivors

ENROLLING
Protocol # :
21-167
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
Phase
III
Disease Sites
Breast
Principal Investigator
Partridge, Ann, H

Trial Description

This clinical trial compares a web-based patient-reported symptom monitoring and self
management portal, Young, Empowered & Strong (YES), to standard therapy in managing symptoms
in adolescent and young adults breast cancer survivors. YES is a web-based portal (website)
to help monitor issues or symptoms women with breast cancer may experience. YES portal may
improve the quality of life of young breast cancer survivors. YES portal may help manage
symptoms and provide useful information/resources.

Eligibility Requirements

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

21-167