This is a multi-site, randomized, three arm, Phase III trial that will evaluate the efficacy of two distinct types of group interventions that are specially designed for younger women who are more than 6 months post initial treatment for breast cancer. The first intervention is a mindfulness meditation-based intervention focused on improving psychological, behavioral, and biological function in younger breast cancer survivors that is adapted from an institutional program in place for the general public at UCLA’s Semel Institute for Neuroscience and Human Behavior. The second intervention is a 6-week didactic group-based survivorship education seminar series that will review specific topics of importance to younger breast cancer survivors including: quality of life after breast cancer; medical management and quality of care post treatment; relationships and work-life balance; body image, sexuality and fertility; energy balance, nutrition, and physical activity; cancer in the family, genetics, and related issues. This curriculum has been adapted from two studies already completed by the investigators, and has a standardized slide set, and will be delivered by a health educator or advanced practice nurse at each of the participating institutions. There will be a maintenance period that follows the 6-week group interventions to help sustain both mindfulness and health behaviors. The third arm of the study (Arm C) will include a usual care group with delayed intervention offered to the participants after they have completed parallel outcome assessments alongside the participants receiving the two interventions (Arm A and Arm B), but not until the end of data collection (6 months after the post-intervention assessments for the cohort).
The purpose of this study is to see how well two different types of group programs—mindfulness-meditation classes and survivorship education classes—meet the needs of young survivors. Up to 360 women were needed for this study.
The initial Call to Action for this study was sent to AOW members on May 3, 2017 and the researchers closed enrollment in August of 2019. The AOW provided them with 358 women who were interested in enrolling in the study.