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Completed

NCT Number: NCT04898855

Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

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.

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Key information

Conditions

Insomnia Cancer Cancer Survivors Dyssomnias Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)

Coimbra, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.

Other names: OncoSleep

Primary outcomes

  1. Insomnia severity

    Time frame: 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 outcomes

  1. Anxiety

    Time frame: 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)

  2. Depression

    Time frame: 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)

  3. Health-related quality of life

    Time frame: 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)

  4. Cancer-related fatigue

    Time frame: 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)

  5. Sleep efficiency

    Time frame: Changes from baseline to post-intervention (8 weeks after randomization)

    Sleep Diary

  6. Total sleep time

    Time frame: Changes from baseline to post-intervention (8 weeks after randomization)

    Sleep Diary

  7. Sleep onset latency

    Time frame: Changes from baseline to post-intervention (8 weeks after randomization)

    Sleep Diary

  8. Number of nocturnal awakenings

    Time frame: Changes from baseline to post-intervention (8 weeks after randomization)

    Sleep Diary

  9. Wake after sleep onset

    Time frame: Changes from baseline to post-intervention (8 weeks after randomization)

    Sleep Diary

Other outcomes

  1. Insomnia Disorder remission (score<8) and response (change ≥8) on the ISI

    Time frame: Post-intervention (8 weeks after randomization)

    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

  2. Acceptability

    Time frame: Post-intervention (8 weeks after randomization)

    Self-report scales of satisfaction, adherence and perceived helpfulness rated on 4-point Likert scales adapted from Manber et al. (2011)

  3. Adherence

    Time frame: Post-intervention (8 weeks after randomization)

    Computed as the number of modules completed

  4. Usability

    Time frame: Post-intervention (8 weeks after randomization)

    User Experience Questionnaire

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia
  • Portuguese Cancer League

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 24, 2021
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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