NCT04766229

The Menopause After Cancer Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: University College Dublin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Cancer
• Insomnia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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

Timeline

• Start date: 2021-06-21
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2021-02-23
• Last updated: 2023-01-06

Locations

2 sites across 1 country: Ireland

Regulatory

• FDA-regulated drug study
• FDA-regulated device study