Improving Outcomes in Early Menopause After Cancer

NCT06982677 | Recruiting DMC

• 2 other identifiers: Pro001178111R21CA301298-01
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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. 1.Is the program easy to join, engaging, and well-received by participants?
2. 2.Does the program group show greater improvements in knowledge, decision-making, confidence, and menopause symptom management compared to the control group?

Conditions

Early Menopause; Cancer; Premature Menopause; Surgical Menopause

Outcome Measures

Primary Outcomes (5)

• Feasibility: Enrollment

  Feasibility will be assessed by examining trial enrollment over the course of 10 months. The trial will be considered feasible if the study enrolls N=60 participants in 10 months, or 100% of the enrollment goal within 10 months. Thus, enrollment will be assessed by measuring the percentage of the enrollment goal at the end of 10 months.

  10 months

• Feasibility: Attrition

  Feasibility will be assessed by examining attrition. Attrition will be measured by the percentage of participants who drop out of the study. The intervention will be considered feasible if \>80% of participants complete 6 sessions.

  10 weeks

• Feasibility: Use of intervention strategies

  Feasibility will be assessed by examining participants' use of intervention strategies using a novel measure adapted for this study. Participants will be asked how often they have used the strategies presented in the intervention, with responses ranging from 0 ("Not at all") to 5 ("Every day"). Participants will also be asked about how often they have used each individual strategy or skill with responses ranging from 0 ("Not at all") to 4 ("6 or more days/week"). The intervention will be considered feasible if ≥75% of participants report use of intervention skills.

  10 weeks

• Acceptability: Treatment Acceptability Questionnaire

  Acceptability will be assessed using the Treatment Acceptability Questionnaire (TAQ). The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable"). The intervention will be considered acceptable if \>80% of participants rate the intervention as \>5 out of 7 on the TAQ.

  10 weeks

• Acceptability: Client Satisfaction Questionnaire

  Acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item self-report scale to assess participant satisfaction; each item on this scale is scored from 1 to 4, with higher scores indicating higher satisfaction. The intervention will be considered acceptable if \>80% of participants rate the intervention as \>3 out of 4 on the CSQ.

  10 weeks

Secondary Outcomes (9)

• Change in risk-based knowledge

  Baseline, 10 weeks

• Change in symptom severity and interference: menopause symptoms

  Baseline, 10 weeks

• Change in symptom severity and interference: anxiety

  Baseline, 10 weeks

• Change in symptom severity and interference: depression

  Baseline, 10 weeks

• Change in symptom severity and interference: illness intrusiveness

  Baseline, 10 weeks

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

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.

Behavioral: Nurse Navigator Intervention

Education Control

OTHER

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

Other: Education Control

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.

Behavioral Intervention

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.

Education Control

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female (biological sex);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Neoplasms; Menopause, Premature

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Rebecca Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smrithi Divakaran, MPH

CONTACT

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

Michael W Willis

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 21, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)