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The Menopause After Cancer Study (MACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04766229
Recruitment Status : Completed
First Posted : February 23, 2021
Last Update Posted : January 6, 2023
Irish Cancer Society
Big Health Inc.
Information provided by (Responsible Party):
Donal Brennan, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual 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 : June 21, 2021
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

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

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 6 months ]
    This will be explored qualitatively using semi structured interviews

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766229

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Mater Misericordiae University Hospital
Dublin, Ireland
St. Vincent's University Hospital
Dublin, Ireland
Sponsors and Collaborators
University College Dublin
Irish Cancer Society
Big Health Inc.
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Principal Investigator: Donal Brennan, PhD UCD Dublin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Donal Brennan, Professor of Gynaecological Oncology, University College Dublin
ClinicalTrials.gov Identifier: NCT04766229    
Other Study ID Numbers: RS21-002
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD with other researchers

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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:
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Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents