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Self-help Treatment for Insomnia in Breast Cancer Patients

NCT00674830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2013-08-15

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

professionally administered cognitive-behavioral therapy

professionally administered CBT-I consisting of six weekly sessions

BEHAVIORAL

self-administered form of cognitive-behavioral therapy

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

BEHAVIORAL

placebo

usual care

Sponsors & Collaborators

  • Canadian Breast Cancer Research Alliance

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Josée Savard, Ph.D. · Centre de recherche de l'HDQ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00674830 on ClinicalTrials.gov