The Menopause After Cancer Study

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2022-11-30

Brief Summary

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This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.

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Detailed Description

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Patients who are eligible and provide informed consent will be enrolled into this single arm study. Patients will be prescribed non-hormonal pharmacotherapy tailored to the timing of their predominant symptoms. They will be given access to an evidence based platform for digital CBT for insomnia and asked to identify a partner or other companion who will commit to providing psychosocial support to the research participant throughout the study period.

Conditions

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Menopause Cancer Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single Arm

All participants in single arm study

Group Type EXPERIMENTAL

Citalopram +/- Gabapentin + Sleepio + support person

Intervention Type COMBINATION_PRODUCT

All participants will receive citalopram and/or gabapentin to manage vasomotor symptoms of menopause and will get access to digital CBT for insomnia and be asked to identify a support person

Interventions

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Citalopram +/- Gabapentin + Sleepio + support person

All participants will receive citalopram and/or gabapentin to manage vasomotor symptoms of menopause and will get access to digital CBT for insomnia and be asked to identify a support person

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

1. Females over 18 years of age at the time of recruitment and onboarding.
2. Vasomotor symptoms of menopause
3. Previous or current cancer diagnosis
4. Conventional menopausal hormone therapy contraindicated for any reason
5. Can speak and read English proficiently
6. Competent using the internet and has access to smartphone or similar device

Exclusion Criteria

1. ECOG performance status \>3
2. Use of study medications to manage menopausal symptoms in the preceding 6 months
3. Use of CBT for insomnia in the preceding 6 months
4. Any contraindication to study medications
5. No internet access or competency issue with internet use
6. Unable to complete questionnaires or give informed consent
7. Current major mental illness

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No