Actively Recruiting
Implementation of CBT-I in Cancer Clinics
Led by CHU de Quebec-Universite Laval · Updated on 2024-09-19
120
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
Sponsors
C
CHU de Quebec-Universite Laval
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics. This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.
CONDITIONS
Official Title
Implementation of CBT-I in Cancer Clinics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have received a diagnosis of non-metastatic cancer (any type)
- Be aged 18 years or older
- Be able to read and understand French or English
- Have the cognitive ability to read, understand, and memorize information
- Have access to the Internet
You will not qualify if you...
- Have a psychological condition needing clinical attention (e.g., major depressive disorder)
- Have severe cognitive impairments (e.g., Parkinson's disease, dementia)
- Have insomnia caused by a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre de recherche de L'Hôtel-Dieu de Québec
Québec, Canada, G1R 2J6
Actively Recruiting
Research Team
J
Josée Savard, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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