Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

Programa Online De Intervenção Cognitivo-Comportamental Para O Tratamento Da Insónia Em Sobreviventes Oncológicos

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Insomnia; Cancer Survivors
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal
    • Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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>=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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University of Coimbra
• Collaborators: Fundação para a Ciência e a Tecnologia; Portuguese Cancer League

Publications and helpful links

Helpful Links

• OncoSleep website

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: cancer; insomnia; cancer survivors; internet intervention; CBTI; digital CBT-I
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2020.05728.BD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No