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
Qualifiers
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
Treatments tested in this trial
- Nurse Navigator Intervention
- Education Control
Treatment groups
117 Participants
are divided into 2 treatment groupsSponsors and collaborators
Duke University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov