Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

Not Applicable

Completed

• Conditions: Insomnia; Cancer; Cancer Survivors
• Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT04898855
• Lead Sponsor: University of Coimbra

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-24
• Study Start: 2023-08-19
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)	Cognitive Behavioral Therapy for Insomnia	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
Sleep efficiency	Changes from baseline to post-intervention (8 weeks after randomization)	Sleep Diary
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

Trial Locations

Locations (1)

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC); 🇵🇹 Coimbra, Portugal