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Improving Outcomes in Early Menopause After Cancer

NCT06982677 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Early Menopause
  • Cancer
  • Premature Menopause
  • Surgical Menopause

Interventions

BEHAVIORAL

Nurse 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.

OTHER

Education 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Rebecca Shelby, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982677 on ClinicalTrials.gov