Self-help Treatment for Insomnia in Breast Cancer Patients

CHU de Quebec-Universite Laval240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Insomnia

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

sleep diary indices, actigraphy, Insomnia Severity Index

Time frame: pre-treatment, post-treatment, 3 follow-up

Secondary Outcomes

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

Time frame: pre-treatement, post-treatment, 3 follow-up