NCT00674830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

5.3 years

First QC Date

May 7, 2008

Last Update Submit

August 14, 2013

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • sleep diary indices, actigraphy, Insomnia Severity Index

    pre-treatment, post-treatment, 3 follow-up

Secondary Outcomes (1)

  • EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs

    pre-treatement, post-treatment, 3 follow-up

Study Arms (3)

1

EXPERIMENTAL

professionally administered cognitive-behavioral therapy

Behavioral: professionally administered cognitive-behavioral therapy

2

EXPERIMENTAL

self-administered form of cognitive behavioral therapy

Behavioral: self-administered form of cognitive-behavioral therapy

3

PLACEBO COMPARATOR

usual care

Behavioral: placebo

Interventions

professionally administered cognitive-behavioral therapyBEHAVIORAL

professionally administered CBT-I consisting of six weekly sessions

1
self-administered form of cognitive-behavioral therapyBEHAVIORAL

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

2
placeboBEHAVIORAL

usual care

3

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche de l'HDQ

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (3)

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PMID: 41170811DERIVED

  • Savard J, Ivers H, Savard MH, Morin CM. Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer. Sleep. 2016 Apr 1;39(4):813-23. doi: 10.5665/sleep.5634.

    PMID: 26715229DERIVED

  • Savard J, Ivers H, Savard MH, Morin CM. Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer? Results of a randomized controlled trial. Sleep. 2014 Aug 1;37(8):1305-14. doi: 10.5665/sleep.3918.

    PMID: 25083010DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Josée Savard, Ph.D.

    Centre de recherche de l'HDQ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 8, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

CA(1)