Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

Study Overview
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Brief Summary
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The main purpose of this study is to determine the treatment effects, feasibility, and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.

Official Title
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Programa Online de intervenção Cognitivo-Comportamental Para o Tratamento da Insónia em Sobreviventes Oncológicos

Conditions
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Insomnia, Survivorship, Cancer

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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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 Have 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 3 months No participation in any other interventional study or clinical trial Exclusion Criteria: Age ≤ 18 years Absence of clinically or subclinical significant symptoms No history of cancer Inability to provide informed consent Inability to use a computer and/or smartphone No access to the internet Another untreated sleep diagnosis Current major psychiatric or medical condition Pregnancy or breastfeeding Parallel ongoing psychological treatment for insomnia Habitual night shift, or rotating shift-workers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)<br>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. | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.<br>* Other names: OncoSleep;|
| No Intervention: waitlist control<br>Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity | Insomnia Severity Index (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) | Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | Sleep Diary | Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups | 
| Total sleep time | Sleep Diary | Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups | 
| Number of nocturnal awakenings | Sleep Diary | Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups | 
| Wake after sleep onset | Sleep Diary | Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups | 
| Sleep onset latency | Sleep Diary | Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups | 
| 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 enrollment); 3- and 6- months follow-ups | 
| 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 enrollment); 3- and 6- months follow-ups | 
| 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 enrollment); 3- and 6- months follow-ups | 
| Depression | Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest depression level) | Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, cancer, survivorship, CBTI, iCBTI