Menopause Clinical Trials

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Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Duke Cancer Institute
RECRUITING
Durham
Contact Information
Primary
Smrithi Divakaran, MPH
smrithi.divakaran@duke.edu
919-681-7695
Backup
Michael W Willis
michael.w.willis@duke.edu
919-681-8437
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2027-05
Participants
Target number of participants: 117
Treatments
Experimental: Behavioral Intervention
Participants will engage in a 6-session program, to be delivered by a nurse navigator in an individual therapy setting, via telehealth. The program will integrate education, decision support, patient activation strategies, and cognitive-behavioral menopause symptom management skills.
Other: Education Control
Participants will receive the National Cancer Institute booklet, Facing Forward: Life After Cancer Treatment, which provides basic strategies for navigating cancer survivorship.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov