Clinical trial NCT06982677: Improving Outcomes in Early Menopause After Cancer
Official title: Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Menopause
Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Enrollment
timeFrame: 10 months
measure: Feasibility: Attrition
timeFrame: 10 weeks
measure: Feasibility: Use of intervention strategies
timeFrame: 10 weeks
measure: Acceptability: Treatment Acceptability Questionnaire
timeFrame: 10 weeks
measure: Acceptability: Client Satisfaction Questionnaire
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in risk-based knowledge
timeFrame: Baseline, 10 weeks
measure: Change in symptom severity and interference: menopause symptoms
timeFrame: Baseline, 10 weeks
measure: Change in symptom severity and interference: anxiety
timeFrame: Baseline, 10 weeks
measure: Change in symptom severity and interference: depression
timeFrame: Baseline, 10 weeks
measure: Change in symptom severity and interference: illness intrusiveness
timeFrame: Baseline, 10 weeks
measure: Change in decisional conflict
timeFrame: Baseline, 10 weeks
measure: Change in self-efficacy: decision self-efficacy
timeFrame: Baseline, 10 weeks
measure: Change in self-efficacy: self-efficacy for managing symptoms
timeFrame: Baseline, 10 weeks
measure: Change in patient activation
timeFrame: Baseline, 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Rebecca Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References: