Trial Information
Self-help Treatment for Insomnia in Breast Cancer Patients
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
sleep diary indices, actigraphy, Insomnia Severity Index
Outcome Time Frame:
pre-treatment, post-treatment, 3 follow-up
Safety Issue:
No
Principal Investigator
Josée Savard, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre de recherche de l'HDQ
Authority:
Canada: Ethics Review Committee
Study ID:
017738
NCT ID:
NCT00674830
Start Date:
April 2008
Completion Date:
September 2013
Related Keywords:
- Insomnia
- Breast Neoplasms
- Sleep Initiation and Maintenance Disorders