Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
Programa Online De Intervenção Cognitivo-Comportamental Para O Tratamento Da Insónia Em Sobreviventes Oncológicos
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedStudy Start
First participant enrolled
August 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedOctober 9, 2024
September 1, 2024
12 months
May 12, 2021
October 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (9)
Anxiety
Changes from baseline to post-intervention (8 weeks after randomization)
Depression
Changes from baseline to post-intervention (8 weeks after randomization)
Health-related quality of life
Changes from baseline to post-intervention (8 weeks after randomization)
Cancer-related fatigue
Changes from baseline to post-intervention (8 weeks after randomization)
Sleep efficiency
Changes from baseline to post-intervention (8 weeks after randomization)
- +4 more secondary outcomes
Other Outcomes (4)
Insomnia Disorder remission (score<8) and response (change ≥8) on the ISI
Post-intervention (8 weeks after randomization)
Acceptability
Post-intervention (8 weeks after randomization)
Adherence
Post-intervention (8 weeks after randomization)
- +1 more other outcomes
Study Arms (2)
OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)
EXPERIMENTALParticipants 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 INTERVENTIONParticipants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks.
Interventions
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Coimbralead
- Portuguese Cancer Leaguecollaborator
- Fundação para a Ciência e a Tecnologiacollaborator
Study Sites (1)
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)
Coimbra, Portugal
Related Publications (2)
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.
PMID: 41170811DERIVEDClara 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.
PMID: 39987779DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD candidate
Study Record Dates
First Submitted
May 12, 2021
First Posted
May 24, 2021
Study Start
August 19, 2023
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
October 9, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share