Self-help Treatment for Insomnia in Breast Cancer Patients

August 14, 2013 updated by: CHU de Quebec-Universite Laval
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1R 2J6
        • Centre de recherche de l'HDQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
professionally administered cognitive-behavioral therapy
Behavioral: professionally administered cognitive-behavioral therapy
professionally administered CBT-I consisting of six weekly sessions
Experimental: 2
self-administered form of cognitive behavioral therapy
Behavioral: self-administered form of cognitive-behavioral therapy
self-administered CBT-I consisting of six short booklets and videotapes
Placebo Comparator: 3
usual care
Behavioral: placebo
usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sleep diary indices, actigraphy, Insomnia Severity Index
Time Frame: pre-treatment, post-treatment, 3 follow-up
pre-treatment, post-treatment, 3 follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs
Time Frame: pre-treatement, post-treatment, 3 follow-up
pre-treatement, post-treatment, 3 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Breast Cancer Research Alliance

Investigators

  • Principal Investigator: Josée Savard, Ph.D., Centre de recherche de l'HDQ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017738

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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