The 'Young, Empowered & Strong' (YES) study is underway to evaluate the effectiveness of a novel mHealth intervention designed to improve the quality of life (QOL) and address the unique concerns of adolescent and young adult (AYA) breast cancer survivors. This multicenter, randomized controlled trial is enrolling 400 participants across the United States to assess the impact of the YES intervention compared to usual care.
Addressing Unmet Needs in AYA Breast Cancer Survivors
Breast cancer in AYAs, defined as individuals under 40, presents unique challenges. Approximately 13,000 new cases are reported annually in the U.S., representing 15% of all new AYA cancers. These patients often face more aggressive tumors and advanced stages of the disease compared to older adults. While treatment advances have improved outcomes, AYAs remain at higher risk of recurrence and mortality. They also experience disruptions in life trajectories and significant long-term physical, emotional, and psychosocial impacts.
AYA survivors often report unmet needs related to body image, menopausal symptoms, mental health, fatigue, and sexual dysfunction, as well as concerns about fertility, employment, and finances. These issues can influence treatment decisions and health behaviors. The healthcare system is often ill-equipped to address these intensive needs, particularly after active treatment ends. The YES study seeks to bridge this gap by providing accessible support and resources tailored to the specific challenges faced by young breast cancer survivors.
The YES Intervention: A Mobile Health Approach
The YES intervention is a mobile app- and web-based platform designed to engage and support young women newly diagnosed with early-stage breast cancer. It utilizes serial symptom monitoring through electronic patient-reported outcome systems (ePROs) to identify and address individual concerns and symptoms outside of a clinical setting. Participants report concerns (e.g., fertility, genetics, body image, financial concerns) and symptoms (e.g., sexual problems, anxiety, fatigue, sleep problems) at regular intervals, receiving tailored education and resources in response.
The YES portal includes features such as:
- Symptom and concern tracking graphs
- Informational resource sheets
- Anonymized participant group chat
- Optional journaling activity
- Helpful websites and resources
Participants randomized to the YES intervention arm are prompted to complete monthly assessments for six months, with intermittent reminders to engage with the portal's resources. The control arm receives usual care and is offered access to the YES portal after completing their study requirements.
Study Design and Methods
The YES study is a two-arm, unblinded randomized controlled trial conducted at three sites in the United States: The Ohio State University (OSU), Dana-Farber Cancer Institute (DFCI), and Columbia University Medical Center (CUMC). Participants are randomized 1:1, stratified by age at diagnosis, time since diagnosis, and study site.
Eligibility criteria include being biologically female, aged 15-39 at diagnosis of stage 0-III breast cancer, within 3 years of diagnosis, and having no evidence of recurrence or other malignancy. The primary outcome is the change in Quality of Life in Adult Cancer Survivors (QLACS) scores from baseline to 6 months. Secondary outcomes include changes in AYA concerns and symptom frequencies.
Data collection includes REDCap surveys at baseline, 3, 6, and 9 months, as well as remote blood collection for biomarker analysis. Intervention acceptability and use are assessed among those randomized to the YES arm. The study also includes exit interviews and semi-structured interviews to gather qualitative data on participants' experiences.
Planned Analyses and Potential Impact
The primary analysis will use repeated measures linear modeling to compare the intervention and usual care arms with respect to changes in QLACS scores. Mediators and moderators of intervention efficacy will also be evaluated. Secondary outcomes will be analyzed using repeated measures regression models. The study will also explore the efficacy of the YES intervention stratified by age, geography, race, and other relevant subgroups.
The YES study has the potential to significantly improve the lives of young breast cancer survivors by providing accessible, tailored support to address their unique needs and concerns. The findings may also inform the development of similar interventions for AYA survivors of other cancers.
