Improving Outcomes in Early Menopause After Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorDuke University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse Navigator Intervention
BehavioralThe 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
Other interventionThe control arm will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.
Treatment groups
117 Participants
are divided into 2 treatment groupsGroup A: Behavioral InterventionExperimental treatment 1 intervention
Group B: Education ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 months2
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.
Time frame
10 weeks3
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.
Time frame
10 weeks4
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.
Time frame
10 weeksSecondary outcomes
1
Change in risk-based knowledge
Knowledge will be assessed using an item pool developed for the study. Each participant will complete 10 items based on the risk-based education they received. Knowledge will be calculated as the percent of correct items (from 0% to 100%).
Time frame
Baseline, 10 weeks2
Change in symptom severity and interference: menopause symptoms
Symptom severity and interference will be measured via the Menopause Specific Quality of Life Questionnaire (MENQOL). The 32-item MENQOL assesses the degree of symptom interference in the past week related to four domains: physical symptoms, vasomotor symptoms, psychosocial symptoms, and sexual symptoms. For each symptom that a participant endorses, they will be asked to rate how much they have been bothered by the symptom on a 7-point scale from 0 ("Not at all bothered") to 6 ("Extremely bothered").
Time frame
Baseline, 10 weeks3
Change in symptom severity and interference: anxiety
Symptom severity and interference will be measured via the PROMIS® Anxiety 8-item Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always".
Time frame
Baseline, 10 weeks4
Change in symptom severity and interference: depression
Symptom severity and interference will be measured via the PROMIS® Depression 8-item Short Form, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always."
Time frame
Baseline, 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov