Recruiting

Menopause Program

Sponsor:

Duke University

Code:

NCT06982677

Conditions

Early Menopause

Cancer

Premature Menopause

Surgical Menopause

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Nurse Navigator Intervention

Education Control

Study Details

Brief 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

Study ID

NCT06982677

Start date

Jan 20, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

117 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Feasibility: Enrollment [ Time Frame: 10 months ]
  • Feasibility: Attrition [ Time Frame: 10 weeks ]
  • Feasibility: Use of intervention strategies [ Time Frame: 10 weeks ]
  • Acceptability: Treatment Acceptability Questionnaire [ Time Frame: 10 weeks ]
  • Acceptability: Client Satisfaction Questionnaire [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Smrithi Divakaran, MPH

919-681-7695smrithi.divakaran@duke.edu

Michael W Willis

919-681-8437michael.w.willis@duke.edu

Locations

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Michael W Willis

919-681-8437michael.w.willis@duke.edu

Smrithi Divakaran

919-681-7695smrithi.divakaran@duke.edu

Principal Investigator:

Rebecca Shelby, PhD

More Information

Sponsor

Duke University

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-14.