Abstract OT2-4-02: Young and strong: A randomized trial to evaluate a program for young women with breast cancer

Abstract

Abstract Young women with newly diagnosed breast cancer face substantial challenges including higher risk of disease recurrence and likelihood of harboring a genetic mutation compared with older women. Many young women are also very concerned about their future fertility and this population often feels isolated from other breast cancer survivors due to their age and life stage. Some worry that their doctors are unsure of how to treat them. To address these issues, we developed a comprehensive program at our institution to coordinate and enhance the care, support, and education for young women with breast cancer. The Young and Strong study is a randomized clinical trial (RCT) to evaluate a virtual, exportable, scalable version of this program designed to improve the quality of care and the psychosocial well-being of this vulnerable population. The specific aims of this program are: 1) To develop, pilot, and refine an exportable and sustainable educational and support intervention for young women with breast cancer and their oncology providers (Young Women's Intervention; YWI). 2) To determine the effect of the YWI compared to a contact-time control intervention focused on promoting physical activity (Physical Activity Intervention; PAI) on attention to fertility issues in a RCT: “Young and Strong”. We initially conducted 4 focus groups (n = 36) and 20 key informant interviews, and developed, piloted, and refined the YWI as well as the PAI. Based on this successful work, we launched the Young and Strong study in June 2012 as a cluster-randomized trial at a total of 54 sites (40 community and 14 academic sites across the United States). Randomization is 1:1 between sites, and stratified by practice type (community vs. academic). Each community site will enroll 5-10 participants, each academic site 15 participants. Total recruitment will be 410-610 pts. The primary objective is to evaluate whether YWI, as compared to PAI, is associated with greater attention to fertility issues, assessed via medical record review. In addition, participants will complete assessments at baseline, 3, 6, and 12 months that assess satisfaction with care, psychosocial well-being, physical activity and anthropomorphic changes. Young and Strong activated in June 2012 and all sites have been identified. As of 6/11/2013 the study has been initiated at 53 out of 54 sites, and total of 282 women have enrolled on the study. Eligibility Criteria: 1. Women age 18-45 years at diagnosis 2. Stage I-III invasive breast cancer without known recurrence or metastatic disease 3. Newly-diagnosed (within 3 months of initial diagnosis) 4. Have 1st appt. with a medical oncologist at participating site after the site opens to enrollment 5. Able to read and write in English For further information, contact Ann Partridge, MD, MPH at 888-814-3324. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr OT2-4-02.