Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Portuguese Cancer League | UNKNOWN |
| Fundação para a Ciência e a Tecnologia | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia) | Experimental | Participants assigned to the experimental group receive immediate access to the OncoSleep program, a web-based self-guided cognitive-behavioral intervention for insomnia consisting of 6 weekly sessions. A certified psychologist will monitor the participant's progress and provide feedback. |
|
| waitlist control | No Intervention | Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia severity | 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 | Changes from baseline to post-intervention (8 weeks after randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest anxiety level) | Changes from baseline to post-intervention (8 weeks after randomization) |
| Depression |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Disorder remission (score<8) and response (change ≥8) on the ISI | 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 | Post-intervention (8 weeks after randomization) |
| Acceptability |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC) | Coimbra | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. | |
| 39987779 | Derived | Clara MI, van Straten A, Savard J, Canavarro MC, Allen Gomes A. Web-based cognitive-behavioral therapy for insomnia in cancer survivors: The OncoSleep randomized trial. Sleep Med. 2025 May;129:67-74. doi: 10.1016/j.sleep.2025.02.021. Epub 2025 Feb 18. |
| Label | URL |
|---|---|
| OncoSleep website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest depression level)
| Changes from baseline to post-intervention (8 weeks after randomization) |
| Health-related quality of life | 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) | Changes from baseline to post-intervention (8 weeks after randomization) |
| Cancer-related fatigue | Multidimensional Fatigue Symptom Inventory-Short Form (overall score -24-96, higher scores denote higher levels of cancer-related fatigue) | Changes from baseline to post-intervention (8 weeks after randomization) |
| Sleep efficiency | Sleep Diary | Changes from baseline to post-intervention (8 weeks after randomization) |
| Total sleep time | Sleep Diary | Changes from baseline to post-intervention (8 weeks after randomization) |
| Sleep onset latency | Sleep Diary | Changes from baseline to post-intervention (8 weeks after randomization) |
| Number of nocturnal awakenings | Sleep Diary | Changes from baseline to post-intervention (8 weeks after randomization) |
| Wake after sleep onset | Sleep Diary | Changes from baseline to 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) |
| Post-intervention (8 weeks after randomization) |
| Adherence | Computed as the number of modules completed | Post-intervention (8 weeks after randomization) |
| Usability | User Experience Questionnaire | Post-intervention (8 weeks after randomization) |
| D001523 |
| Mental Disorders |