The Menopause After Cancer Study

Phase 2

Completed

• Conditions: Insomnia; Cancer; Menopause
• Interventions: Combination Product: Citalopram +/- Gabapentin + Sleepio + support person

• Registration Number: NCT04766229
• Lead Sponsor: University College Dublin

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-20
• Study First Posted: 2021-02-23
• Study Start: 2021-06-21
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Citalopram +/- Gabapentin + Sleepio + support person	All participants in single arm study

Primary Outcome Measures

Name	Time	Method
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	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale	6 months	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.
Sleep dysfunction as measured by the Sleep Condition Indicator	6 months	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.

Trial Locations

Locations (2)

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

St. Vincent's University Hospital; 🇮🇪 Dublin, Ireland