The Menopause After Cancer Study (MACS)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Females over 18 years of age at the time of recruitment and onboarding.
- Vasomotor symptoms of menopause
- Previous or current cancer diagnosis
- Conventional menopausal hormone therapy contraindicated for any reason
- Can speak and read English proficiently
- Competent using the internet and has access to smartphone or similar device
Exclusion criteria
- ECOG performance status >3
- Use of study medications to manage menopausal symptoms in the preceding 6 months
- Use of CBT for insomnia in the preceding 6 months
- Any contraindication to study medications
- No internet access or competency issue with internet use
- Unable to complete questionnaires or give informed consent
- Current major mental illness
Trial design
Primary purpose
Allocation
Interventional model
Masking
205 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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