Self-help Treatment for Insomnia in Breast Cancer Patients

Insomnia Clinical Trial

Official title:

Self-help Treatment for Insomnia in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674830
• Other study ID #: 017738
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: August 14, 2013
• Start date: April 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• professionally administered cognitive-behavioral therapy
professionally administered CBT-I consisting of six weekly sessions
• self-administered form of cognitive-behavioral therapy
self-administered CBT-I consisting of six short booklets and videotapes
• placebo
usual care

Locations

Country	Name	City	State
Canada	Centre de recherche de l'HDQ	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Canadian Breast Cancer Research Alliance

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep diary indices, actigraphy, Insomnia Severity Index		pre-treatment, post-treatment, 3 follow-up	No
Secondary	EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs		pre-treatement, post-treatment, 3 follow-up	No