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| Name | Class |
|---|---|
| Irish Cancer Society | OTHER |
| Big Health Inc. | INDUSTRY |
| myPatientSpace | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All participants in single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Communication between participants and support person as measured by the Couples' Illness Communication Score. | 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. | 6 months |
| The experience of participating in the couples communication aspect of the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donal Brennan, PhD | UCD Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mater Misericordiae University Hospital | Dublin | Ireland | ||||
| St. Vincent's University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34869938 | Derived | 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. |
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We do not plan to share IPD with other researchers
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Sleep dysfunction as measured by the Sleep Condition Indicator | 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. | 6 months |
This will be explored qualitatively using semi structured interviews |
| 6 months |
| Dublin |
| Ireland |
| D001523 |
| Mental Disorders |