Clinical trial · Interventional
The Menopause After Cancer Study
A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study
NCT04766229CI-TRIAL-00063059MACScompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
| Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Citalopram +/- Gabapentin + Sleepio + support person | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- All participants in single arm study
- interventionNames
- Combination Product: Citalopram +/- Gabapentin + Sleepio + support person
Primary outcomes (1)
- measure
- 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
- timeFrame
- 6 months
- description
- 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 (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDonohoe 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