Improving Outcomes in Early Menopause After Cancer
This study is testing a new program called the Nurse Navigator Intervention to help women who experience early menopause (when periods stop before age 45) after cancer treatment. This program offers personalized education, help with making decisions, and skills to manage menopause symptoms. Another group will receive an educational booklet. The study wants to see if the Nurse Navigator Intervention is easy to use and if it helps women improve their knowledge, confidence, and symptom management more than the booklet. You might be able to join if you are a woman between 18 and 44, finished cancer treatment (not including hormone therapy) over a year ago, and haven't had a period for more than 12 months. The study aims to enroll 117 participants.
- Study design
- This is an interventional study with two groups: one receiving the Nurse Navigator Intervention and another receiving an educational control program. It aims to enroll 117 participants.
- What's involved
- Participants will complete sessions with a nurse navigator via video and fill out questionnaires at the start of the study and again about 10 weeks later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for approximately 10 weeks after starting the study.
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Improving Outcomes in Early Menopause After Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rebecca Shelby, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility: Enrollment10 months
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.
- Feasibility: Attrition10 weeks
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.
- Feasibility: Use of intervention strategies10 weeks
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.
- Acceptability: Treatment Acceptability Questionnaire10 weeks
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.
- Acceptability: Client Satisfaction Questionnaire10 weeks
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.