The Menopause After Cancer Study

NCT04766229 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: RS21-002
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

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.

Conditions

Menopause; Cancer; Insomnia

Outcome Measures

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

  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 Outcomes (2)

• Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale

  6 months

• Sleep dysfunction as measured by the Sleep Condition Indicator

  6 months

Other Outcomes (2)

• Communication between participants and support person as measured by the Couples' Illness Communication Score.

  6 months

• The experience of participating in the couples communication aspect of the study

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

All participants in single arm study

Combination Product: Citalopram +/- Gabapentin + Sleepio + support person

Interventions

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Irish Cancer Society: collaborator
• Big Health Inc.: collaborator
• myPatientSpace: collaborator

Study Sites (2)

Mater Misericordiae University Hospital

Dublin, Ireland

Location

St. Vincent's University Hospital

Dublin, Ireland

Location

Related Publications (1)

• Donohoe F, O'Meara Y, Roberts A, Comerford L, Kelly CM, Walshe JM, Peate M, Hickey M, Brennan DJ. The menopause after cancer study (MACS) - A multimodal technology assisted intervention for the management of menopausal symptoms after cancer - Trial protocol of a phase II study. Contemp Clin Trials Commun. 2021 Nov 11;24:100865. doi: 10.1016/j.conctc.2021.100865. eCollection 2021 Dec.

  PMID: 34869938 DERIVED

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Donal Brennan, PhD

  UCD Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gynaecological Oncology

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 23, 2021
• Study Start: June 21, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)