The effectiveness of an online intervention for insomnia after childhood cancer
Phase 4
Completed
- Conditions
- <p>childhood cancer insomnia</p>10024324
- Registration Number
- NL-OMON27901
- Lead Sponsor
- Prinses Máxima Centrum voor kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
- diagnosed with insomnia according to the DSM-5 criteria (ISI>8)
- diagnosed with cancer before the age of 19 years
Exclusion Criteria
- anti-cancer treatment within the last 6 months
- patients receiving palliative therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes include sleep efficiency (actigraphic) and insomnia severity (self-report) and will be evaluated at baseline (T0), 3 (T3), 6 (T6) and 12 (T12) months after randomization. Sleep efficiency will be measured with a 7-day watch Actigraph (GTX3+) and sleep log. SE contains information on difficulties falling asleep as well as difficulties staying asleep. Insomnia severity is measured with the Insomnia Severity Index (ISI)-questionnaire.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality of life: Pediatric Quality of Life Inventory (PedsQL) Fatigue: Checklist Individual Strenght (CIS) Depressive and Anxiety symptoms: Hospital Anxiety and Depression Scale (HADS) Chronic stress: Chronic Stress Questionnaire for Children and Adolescents (CSQ-CA) General questionnaire will also be assessed with suicidality and current psychological treatment for psychopathology on T0 and subjective pain, sleep medication use on T3, T6 and T12. Post-treatment intervention feedback and satisfaction of i-Sleep will be evaluated at T3 with a a 20-item satisfaction questionnaire, adherence and intervention feedback per session.</p><br>