Self-help Treatment for Insomnia in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: professionally administered cognitive-behavioral therapy; Behavioral: self-administered form of cognitive-behavioral therapy; Behavioral: placebo

• Registration Number: NCT00674830
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-14
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	professionally administered cognitive-behavioral therapy	professionally administered cognitive-behavioral therapy
2	self-administered form of cognitive-behavioral therapy	self-administered form of cognitive behavioral therapy
3	placebo	usual care

Primary Outcome Measures

Name	Time	Method
sleep diary indices, actigraphy, Insomnia Severity Index	pre-treatment, post-treatment, 3 follow-up

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs	pre-treatement, post-treatment, 3 follow-up

Trial Locations

Locations (1)

Centre de recherche de l'HDQ; 🇨🇦 Québec, Quebec, Canada