Clinical trial NCT04898855: Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
Official title: Programa Online De Intervenção Cognitivo-Comportamental Para O Tratamento Da Insónia Em Sobreviventes Oncológicos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Cancer
Cancer Survivors
Keywords: insomnia
cancer
CBTI
digital CBT-I
internet intervention
cancer survivors
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Portuguese Cancer League
name: Fundação para a Ciência e a Tecnologia
First posted: 2021-05-24
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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\&gt;=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

Primary outcomes:
measure: Insomnia severity
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
Secondary outcomes:
measure: Anxiety
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Depression
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Health-related quality of life
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Cancer-related fatigue
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Sleep efficiency
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Total sleep time
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Sleep onset latency
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Number of nocturnal awakenings
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
measure: Wake after sleep onset
timeFrame: Changes from baseline to post-intervention (8 weeks after randomization)
Other outcomes:
measure: Insomnia Disorder remission (score&amp;amp;amp;lt;8) and response (change ≥8) on the ISI
timeFrame: Post-intervention (8 weeks after randomization)
measure: Acceptability
timeFrame: Post-intervention (8 weeks after randomization)
measure: Adherence
timeFrame: Post-intervention (8 weeks after randomization)
measure: Usability
timeFrame: Post-intervention (8 weeks after randomization)
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)
Study officials:
References: