Clinical trial NCT04766229: The Menopause After Cancer Study
Official title: A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menopause
Cancer
Insomnia
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Irish Cancer Society
name: Big Health Inc.
name: myPatientSpace
First posted: 2021-02-23
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale
timeFrame: 6 months
measure: Sleep dysfunction as measured by the Sleep Condition Indicator
timeFrame: 6 months
Other outcomes:
measure: Communication between participants and support person as measured by the Couples' Illness Communication Score.
timeFrame: 6 months
measure: The experience of participating in the couples communication aspect of the study
timeFrame: 6 months
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
Study officials:
affiliation: UCD Dublin
name: Donal Brennan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.