# A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $643,972

## Abstract

PROJECT SUMMARY
Breast cancer is the most common cancer in women younger than 50 years, accounting for up to 25% of new
breast cancer cases. Improved survival after a breast cancer diagnosis has focused attention on the critical
need to address the impact of the disease and its treatments on long-term outcomes in younger women. This
has become an increasingly important cancer control priority, including federal legislation focusing on the
unique needs of women <45 years old. Studies have consistently shown that younger women have greater
psychological and physical morbidity after breast cancer than older women and age-matched women with no
cancer history, including elevated levels of depression and other behavioral symptoms (i.e., fatigue, sleep
disturbance, vasomotor symptoms) that cause significant impairment in quality of life. Increased behavioral
symptoms have been documented up to 10 years after diagnosis in this population, suggesting that effects
may not remediate without intervention. Younger breast cancer survivors are at risk for adverse long-term
effects, making them a particularly vulnerable population, for whom only a few specific interventions have been
tested. A major barrier to adoption of many behavioral interventions is the lack of a translational research
implementation strategy, and thus these interventions fail to become a standard of care that is clinically
provided and reimbursed. To meet this challenge, we will conduct a phase III, three-group, randomized clinical
trial at three geographically separated NCI-designated comprehensive cancer centers, randomly assigning 360
younger post-treatment breast cancer survivors, to one of two promising interventions (survivorship education
or mindful awareness practices), comparing each to a usual care/waitlist control group. We hypothesize that
both of the intervention programs will be effective in reducing behavioral symptoms (depression - primary
outcome; fatigue, sleep disturbance, vasomotor symptoms-secondary outcomes) over a 6 month post-
intervention period, in comparison to the usual care/waitlist control group. Additionally, we will examine the
efficacy of the interventions relative to the control group on circulating and genomic markers of inflammation,
hypothesizing that the mindfulness intervention will significantly reduce markers of inflammation. Finally, we
will explore potential moderators of intervention efficacy in the intervention groups.

## Key facts

- **NIH application ID:** 9960444
- **Project number:** 5R01CA200977-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** JULIENNE E BOWER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $643,972
- **Award type:** 5
- **Project period:** 2016-07-14 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9960444

## Citation

> US National Institutes of Health, RePORTER application 9960444, A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors (5R01CA200977-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9960444. Licensed CC0.

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