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Self-help Treatment for Insomnia in Breast Cancer Patients


N/A
18 Years
75 Years
Open (Enrolling)
Female
Insomnia

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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

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