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

Young, Empowered & Strong (YES) Study Overview

Background

Adolescents and young adults (AYAs) with breast cancer face more aggressive disease and require intensive treatment, which disrupts their lives. They often have unmet needs related to:

  • Symptoms: Issues like sexual problems, anxiety, fatigue, stress, and hot flashes.
  • Concerns: Topics such as fertility, genetics, relationships, and financial stability.

Addressing these needs can enhance symptom management and quality of life.

What is the YES Trial?

The Young, Empowered and Strong (YES) trial evaluates a 9-month digital health program designed to help AYA breast cancer survivors manage their symptoms and concerns. This program includes:

  • Monthly symptom assessments.
  • A supportive chat room.
  • A journal for tracking personal experiences.

These tools provide tailored information and support outside of clinical settings.

Trial Methods

The YES trial is a multicenter study involving 400 participants from three academic institutions in the U.S. Participants are randomly assigned to either the YES intervention or standard care. Key criteria for inclusion are:

  • Biologically female.
  • Aged 15-39 at diagnosis of stage 0-III breast cancer.
  • Within 3 years of diagnosis with no recurrence.
  • No history of other malignancies since initial diagnosis.
  • Ability to access medical records from treatment sites.

Participants complete surveys at the start and at 3, 6, and 9 months. The main focus is on quality of life, measured by the Quality of Life in Adult Cancer Survivors Scale (QLACS).

Expected Outcomes

The findings will help determine if the YES digital health program effectively addresses the symptoms and concerns of AYA breast cancer survivors. It aims to empower them to manage their health outside of clinical visits.

Trial Registration

Registered at Clinicaltrials.gov, NCT04906200, on May 13, 2021.

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