The Menopause After Cancer Study

Cancer Clinical Trial

— MACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766229
• Other study ID #: RS21-002
• Status: Completed
• Phase: Phase 2
• Start date: June 21, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Insomnia
• Menopause

Intervention

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

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin

Sponsors (4)

Lead Sponsor	Collaborator
University College Dublin	Big Health Inc., Irish Cancer Society, myPatientSpace

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Communication between participants and support person as measured by the Couples' Illness Communication Score.	Will be measured quantitatively using Couples' Illness Communication Score. The minimum score of 8 and a maximum score of 40 with higher scores indicating better communication.	6 months
Other	The experience of participating in the couples communication aspect of the study	This will be explored qualitatively using semi structured interviews	6 months
Primary	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	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
Secondary	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