Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2026-04-30
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Behavioral Intervention
Participants will engage in a 6-session program, to be delivered by a nurse navigator in an individual therapy setting, via telehealth. The program will integrate education, decision support, patient activation strategies, and cognitive-behavioral menopause symptom management skills.
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.
Education Control
Participants will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* visual or hearing impairment that would interfere with participation in study;
* cognitive impairment or severe mental illness that would interfere with participation in study.
18 Years
44 Years
FEMALE
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Rebecca Shelby, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Central Contacts
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Other Identifiers
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Pro00117811
Identifier Type: -
Identifier Source: org_study_id
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