Improving Outcomes in Early Menopause After Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06982677
Status
Recruiting
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Conditions

  • Cancer
  • Early Menopause
  • Premature Menopause
  • Surgical Menopause

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • Nurse Navigator Intervention — BEHAVIORAL
    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.
  • Education Control — OTHER
    The control arm will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
117 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Feasibility: Enrollment [ Time Frame: 10 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27705
Michael W Willis
[email protected]
919-681-8437
Smrithi Divakaran
[email protected]
919-681-7695
Rebecca Shelby, PhD (PRINCIPAL_INVESTIGATOR)

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