MACS: The Menopause After Cancer Study

• Sponsor: University College Dublin (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04766229
• Collaborator: Irish Cancer Society (Other), Big Health Inc. (Industry)
• Enrollment: 205
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 11.3
• Patients Per Site: 102.5
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopause; Cancer; Insomnia	Combination Product: Citalopram +/- Gabapentin + Sleepio + support person	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 205 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study
• Actual Study Start Date: Jun 21, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm All participants in single arm study	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Other Outcome Measures

1. Communication between participants and support person as measured by the Couples' Illness Communication Score. [6 months]

   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.

2. The experience of participating in the couples communication aspect of the study [6 months]

   This will be explored qualitatively using semi structured interviews

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mater Misericordiae University Hospital	Dublin		Ireland
2	St. Vincent's University Hospital	Dublin		Ireland

Sponsors and Collaborators

• University College Dublin
• Irish Cancer Society
• Big Health Inc.

Investigators

• Principal Investigator: Donal Brennan, PhD, UCD Dublin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Donal Brennan, Professor of Gynaecological Oncology, University College Dublin
• ClinicalTrials.gov Identifier: NCT04766229
• Other Study ID Numbers: RS21-002
• First Posted: Feb 23, 2021
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Gabapentin; Citalopram

Study Results

No Results Posted as of Jun 24, 2021