The Menopause After Cancer Study

University College Dublin205 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

205

Conditions

Menopause Cancer Insomnia

Interventions

Citalopram +/- Gabapentin + Sleepio + support personCOMBINATION_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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Mater Misericordiae University Hospital

Dublin, Ireland

St. Vincent's University Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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