Improving outcomes for women experiencing premature or early menopause after cancer: development and pilot testing of a novel intervention

Premature (i.e., occurring before age 40 years) and early menopause (i.e., occurring at age 40-44 years) significantly impact women (biological sex) treated for childhood, adolescent, or early-onset adult cancers. Among these women, premature or early menopause are common, resulting from certain chemotherapies (e.g., alkylating agents), radiation treatments (e.g., pelvic radiation), surgeries (e.g., oophorectomy), and endocrine therapies (e.g., ovarian function suppression). Premature and early menopause elevate the risk for cardiovascular disease, ischemic stroke, type 2 diabetes, osteoporosis, cognitive decline, neurological disorders, and depressive symptoms, which together result in an increased risk of morbidity and early mortality. The significant long-term health impacts of premature and early menopause are further exacerbated by the effects of women’s cancer treatments (e.g., chemotherapy-related cardiotoxicities). Women with premature or early menopause after cancer also commonly experience symptoms such as hot flushes, sleeping problems, and sexual dysfunction that have negative impacts on their daily activities and quality of life. There is a critical need for novel interventions to address the many challenges faced by women experiencing premature or early menopause after cancer. We propose to develop and pilot test a novel nurse navigator-delivered intervention that is guided by the Empowerment Model for Managing Menopause and integrates 1) personalized, risk-based menopause education and decision support guided by the Ottawa Decision Support Framework, 2) skills derived from patient activation theory to improve knowledge, increase self-efficacy, and increase engagement in selfmanagement, and 3) cognitive behavioral based skills to manage menopausal symptoms. Intervention development and initial evaluation are consistent with Stage 1 of the NIH Stage Model for Behavioral Intervention Development. Aim 1. Preliminary intervention content will be developed with input obtained in interviews with women (N=24) experiencing premature or early menopause after cancer and medical providers (N=24) who care for this population. The prototype intervention will be refined with input by the study advisory council. Next, women (N=9) experiencing premature or early menopause after cancer will receive the intervention and provide feedback to further refine content, format, and procedures. Aim 2. Intervention feasibility and acceptability will be examined in a pilot randomized controlled trial (RCT). A new sample of women experiencing premature or early menopause after cancer will be randomized to receive the intervention or educational materials to examine the feasibility of study recruitment (N=60 in 10 months), participant retention (>80% intervention completion) and acceptability. We will also examine patterns of change in intervention targets (i.e., risk-based knowledge, decisional conflict, self-efficacy, patient activation and menopausal symptoms) and exit interview data from intervention participants.