Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention
Duke University
Summary
The goal of this study is to create and test a new program led by nurse navigators to help women who experience early menopause after cancer. The program includes personalized menopause education, decision support, and skills to manage menopause symptoms. The main questions it aims to answer are: 1. Is the program easy to join, engaging, and well-received by participants? 2. Does the program group show greater improvements in knowledge, decision-making, confidence, and menopause symptom management compared to the control group? Participants will complete sessions of either the program being tested or an educational control program with a nurse navigator via video. Participants will also complete questionnaires when they start the study and again about 10 weeks later.
Description
The study aims to develop and pilot test a novel nurse navigator-delivered intervention for women experiencing premature and early menopause after cancer. The proposed intervention integrates 1) personalized, risk-based menopause health education and decision support, 2) skills derived from patient activation theory to increase self-efficacy and engagement in menopause self-management, and 3) cognitive-behavioral theory-based skills (e.g., stress management, relaxation techniques, challenging unhelpful thoughts, and activity pacing) for menopause symptom management. Phase I: Develop and refin…
Eligibility
- Age range
- 18–44 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * female (biological sex); * 18 to 44 years old; * completed cancer treatment (other than endocrine therapy) \>12 months prior to enrollment; * have not had a period for more than 12 months (amenorrhea); * able to speak and read English. Exclusion Criteria: * diagnosis of metastatic cancer; * visual or hearing impairment that would interfere with participation in study; * cognitive impairment or severe mental illness that would interfere with participation in study.
Interventions
- BehavioralNurse Navigator Intervention
The intervention will integrate education, decision support, patient activation strategies, and cognitive-behavioral menopause symptom management skills. Participants will receive video and audio-recorded materials and a written manual.
- OtherEducation Control
The control arm will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.
Location
- Duke Cancer InstituteDurham, North Carolina