The Menopause After Cancer Study

Study Overview
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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.

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.

Official Title
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A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study

Conditions
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Menopause, Cancer, Insomnia

Intervention / Treatment
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* Combination Product: Citalopram +/- Gabapentin + Sleepio + support person


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>All participants in single arm study | Combination Product: Citalopram +/- Gabapentin + Sleepio + support person<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Quality of Life scores as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) instrument | Global quality of life will be assessed using the EORTC QLQ C30 questionnaire. This is a 30 item questionnaire which has been extensively validated internationally and is specific to patients treated for cancer. Minimum global quality of life score is 0 with a maximum of 100 with a higher score representing a better quality of life. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale | This will be measured by the Hot Flush Rating Scale which measures both frequency and impact of vasomotor symptoms. For this scale the minimum score is 1 and maximum score is 10 with higher scores indicating a greater degree of bother/interference. | 6 months | 
| Sleep dysfunction as measured by the Sleep Condition Indicator | This will be measured using the Sleep Condition Indicator tool. Minimum score is 0 with maximum score of 32 with higher scores indicating better sleep. | 6 months |