Improving Outcomes in Early Menopause After Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurse Navigator Intervention, Education Control.
- Who it may be relevant to
- Registry conditions: Early Menopause, Cancer, Premature Menopause, Surgical Menopause. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention
Overview
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
The study aims to develop and pilot test a novel nurse navigator-delivered intervention for women experiencing premature and early menopause after cancer. The proposed intervention integrates 1) personalized, risk-based menopause health education and decision support, 2) skills derived from patient activation theory to increase self-efficacy and engagement in menopause self-management, and 3) cognitive-behavioral theory-based skills (e.g., stress management, relaxation techniques, challenging unhelpful thoughts, and activity pacing) for menopause symptom management.
Phase I: Develop and refine an intervention for women experiencing premature or early menopause after cancer. The intervention content will be developed and refined with input and review by women cancer survivors experiencing premature or early menopause (N=24) and medical providers (N=24) who care for this population. The intervention will be further refined with input and review by our study advisory council. Next, user testing (N=9) will be conducted to guide further refinement of content, format and procedures and to obtain feedback for finalizing the intervention protocol that will then be tested in a small pilot randomized controlled trial.
Phase II: Pilot randomized controlled trial (RCT) to examine the feasibility and acceptability of the developed intervention. A new sample of female cancer survivors experiencing premature or early menopause will be randomized to receive the intervention or educational materials for cancer survivors developed by the National Cancer Institute (NCI) to examine the feasibility of study recruitment, participant retention and acceptability.
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.
Primary outcome measures
- 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]
Secondary outcome measures (9)
- Change in risk-based knowledge [Time frame: Baseline, 10 weeks]
- Change in symptom severity and interference: menopause symptoms [Time frame: Baseline, 10 weeks]
- Change in symptom severity and interference: anxiety [Time frame: Baseline, 10 weeks]
- Change in symptom severity and interference: depression [Time frame: Baseline, 10 weeks]
- Change in symptom severity and interference: illness intrusiveness [Time frame: Baseline, 10 weeks]
- Change in decisional conflict [Time frame: Baseline, 10 weeks]
- Change in self-efficacy: decision self-efficacy [Time frame: Baseline, 10 weeks]
- Change in self-efficacy: self-efficacy for managing symptoms [Time frame: Baseline, 10 weeks]
- Change in patient activation [Time frame: Baseline, 10 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Duke Cancer Institute — Durham
Identifiers
NCT: NCT06982677 · Pro00117811 · 1R21CA301298-01