Cancer, Cancer Survivors, Insomnia
Conditions
Keywords
insomnia, cancer, CBTI, digital CBT-I, internet intervention, cancer survivors
Brief summary
The main purpose of this study is to determine the treatment effects and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
Sponsors
Portuguese Cancer League
Fundação para a Ciência e a Tecnologia
University of Coimbra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ years * Provided informed consent * Ability to read and write in Portuguese * Ability to use a computer and/or smartphone, and the internet * History of cancer * Having completed primary cancer treatment (survivors who are on hormone and/or other long-term maintenance therapy agencies are eligible to participate) * Subclinical or significant symptoms of insomnia (ISI scores>=8) * Ongoing sleep medication accepted if the dosage has been stable during the last 4 weeks
Exclusion criteria
* Age ≤ 18 years * Another unstable condition (e.g., sleep, psychiatric or medical condition) * Pregnancy or breastfeeding * Concurrent CBT-I * Habitual night shift, or rotating shift-workers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity | Changes from baseline to post-intervention (8 weeks after randomization) | Insomnia Severity Index: validated questionnaire among cancer survivors; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-related fatigue | Changes from baseline to post-intervention (8 weeks after randomization) | Multidimensional Fatigue Symptom Inventory-Short Form (overall score -24-96, higher scores denote higher levels of cancer-related fatigue) |
| Total sleep time | Changes from baseline to post-intervention (8 weeks after randomization) | Sleep Diary |
| Sleep onset latency | Changes from baseline to post-intervention (8 weeks after randomization) | Sleep Diary |
| Number of nocturnal awakenings | Changes from baseline to post-intervention (8 weeks after randomization) | Sleep Diary |
| Wake after sleep onset | Changes from baseline to post-intervention (8 weeks after randomization) | Sleep Diary |
| Anxiety | Changes from baseline to post-intervention (8 weeks after randomization) | Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest anxiety level) |
| Depression | Changes from baseline to post-intervention (8 weeks after randomization) | Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest depression level) |
| Health-related quality of life | Changes from baseline to post-intervention (8 weeks after randomization) | European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30; World Health Organization Quality of Life - Brief (overall scores 0-100, higher scores indicate higher quality of life) |
| Sleep efficiency | Changes from baseline to post-intervention (8 weeks after randomization) | Sleep Diary |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Post-intervention (8 weeks after randomization) | Computed as the number of modules completed |
| Usability | Post-intervention (8 weeks after randomization) | User Experience Questionnaire |
| Acceptability | Post-intervention (8 weeks after randomization) | Self-report scales of satisfaction, adherence and perceived helpfulness rated on 4-point Likert scales adapted from Manber et al. (2011) |
| Insomnia Disorder remission (score<8) and response (change ≥8) on the ISI | Post-intervention (8 weeks after randomization) | Overall score 0-28 interpreted as follows: 0-7 absence of insomnia; 8-14 sub-threshold insomnia; 15-21 moderate insomnia; 22-28 severe insomnia |
Countries
Portugal
Outcome results
None listed