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Completed

NCT Number: NCT04766229

The Menopause After Cancer Study

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.

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Key information

Conditions

Menopause Cancer Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mater Misericordiae University Hospital, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females over 18 years of age at the time of recruitment and onboarding.
  • Vasomotor symptoms of menopause
  • Previous or current cancer diagnosis
  • Conventional menopausal hormone therapy contraindicated for any reason
  • Can speak and read English proficiently
  • Competent using the internet and has access to smartphone or similar device

Exclusion criteria

  • ECOG performance status >3
  • Use of study medications to manage menopausal symptoms in the preceding 6 months
  • Use of CBT for insomnia in the preceding 6 months
  • Any contraindication to study medications
  • No internet access or competency issue with internet use
  • Unable to complete questionnaires or give informed consent
  • Current major mental illness

Treatment and study plan

Citalopram +/- Gabapentin + Sleepio + support person

Combination 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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • Big Health Inc.
  • Irish Cancer Society
  • myPatientSpace

Registry information

Official study title

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

Acronym: MACS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2021
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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