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Completed

NCT Number: NCT00674830

Self-help Treatment for Insomnia in Breast Cancer Patients

The main goal of this population-based study is to assess the efficacy of two forms of cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with breast cancer: a professionally administered form and a patient self-administered form. It is hypothesized that the two treatment conditions will be associated with significantly greater improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of life, relative to the control condition (i.e., usual care). It is also hypothesized that the magnitude of effect sizes obtained in association with treatment at each time assessment will be greater for the professionally administered treatment than the self-administered treatment.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de l'HDQ

Québec, Quebec, G1R 2J6, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • To be receiving treatment for a diagnosis of breast or gynaecological cancer
  • To obtain a score of 8 or higher on the Insomnia Severity Index (ISI) or to be using a hypnotic medication ≥ 1 night per week

Exclusion criteria

  • To have received a diagnosis or being treated for :
  • a sleep disorder other than insomnia (e.g., sleep apnea)
  • a severe psychiatric disorder (e.g., psychotic disorder)
  • a severe cognitive disorder (e.g., dementia)

Treatment and study plan

professionally administered cognitive-behavioral therapy

Behavioral

professionally administered CBT-I consisting of six weekly sessions

self-administered form of cognitive-behavioral therapy

Behavioral

self-administered CBT-I consisting of six short booklets and videotapes

Placebo

Behavioral

usual care

Primary outcomes

  1. sleep diary indices, actigraphy, Insomnia Severity Index

    Time frame: pre-treatment, post-treatment, 3 follow-up

Secondary outcomes

  1. EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs

    Time frame: pre-treatement, post-treatment, 3 follow-up

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Breast Cancer Research Alliance

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 8, 2008
Registry last updated
Aug 15, 2013

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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