Improving Outcomes in Early Menopause After Cancer

NCT ID: NCT06982677

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Menopause Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nurse Navigator Intervention

Intervention Type 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

Participants will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.

Group Type OTHER

Education Control

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Shelby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Central Contacts

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Smrithi Divakaran, MPH

Role: CONTACT

919-681-7695

Michael W Willis

Role: CONTACT

919-681-8437

Other Identifiers

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Pro00117811

Identifier Type: -

Identifier Source: org_study_id

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