Cancer, Insomnia, Menopause
Conditions
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.
Interventions
COMBINATION_PRODUCTCitalopram +/- Gabapentin + Sleepio + support person
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
Sponsors
Irish Cancer Society
Big Health Inc.
myPatientSpace
University College Dublin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale | 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. |
| Sleep dysfunction as measured by the Sleep Condition Indicator | 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
| Measure | Time frame | Description |
|---|---|---|
| Communication between participants and support person as measured by the Couples' Illness Communication Score. | 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. |
| The experience of participating in the couples communication aspect of the study | 6 months | This will be explored qualitatively using semi structured interviews |
Countries
Ireland
Outcome results
None listed