Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898855
• Other study ID #: 2020.05728.BD
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University of Coimbra
• Contact: Maria Clara
• Phone: +351 911820289
• Email: mclara[@]uc.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Survivorship

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.

Locations

Country	Name	City	State
Portugal	Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
University of Coimbra

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility as assessed by recruitment, retention/attrition data	Computed as the number of participants that registered to enroll, dropped out before completing the intervention and completed the intervention	Post-intervention (8 weeks after enrollment)
Other	Feasibility as assessed by usage (program visit length, completion of activities)	Computed as the average duration of participants' visits to the intervention, sleep diary logs, homework activities	Post-intervention (8 weeks after enrollment)
Other	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 enrollment)
Other	Usability	User Experience Questionnaire	Post-intervention (8 weeks after enrollment)
Primary	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	Sleep efficiency	Sleep Diary	Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Secondary	Total sleep time	Sleep Diary	Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Secondary	Number of nocturnal awakenings	Sleep Diary	Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Secondary	Wake after sleep onset	Sleep Diary	Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Secondary	Sleep onset latency	Sleep Diary	Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Secondary	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
Secondary	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
Secondary	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
Secondary	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