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CBT-I for Insomnia in Cancer Patients

N/A
Recruiting
Led By Josée Savard, Ph.D.
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
To be aged 18 years and older
Have received a diagnosis of non-metastatic cancer (any type)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months
Awards & highlights

Study Summary

This trial will study 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.

Who is the study for?
This trial is for adults over 18 with non-metastatic cancer who can read and understand French or English, have basic cognitive abilities, and internet access. It's not suitable for those with severe psychological issues like major depression, significant cognitive impairments such as dementia, or insomnia caused by temporary conditions.Check my eligibility
What is being tested?
The study tests a stepped care approach to treating insomnia in cancer patients using web-based CBT-I (Insomnet) followed by up to three professional therapy sessions if needed. The effectiveness of this method will be compared against usual care in a real-world setting across four hospitals.See study design
What are the potential side effects?
As the intervention involves non-pharmacological treatment (CBT-I), typical medication side effects are not expected. However, participants may experience discomfort discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with cancer that has not spread.
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I have been diagnosed with cancer that has not spread.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1) Efficiency (patients) measures
1) Fidelity to the treatment protocol (psychologists)
10) Efficiency (patients) measures
+10 more
Secondary outcome measures
1) Possible predictors of a better program uptake
2) Possible predictors of a better program uptake
3) Possible predictors of a better program uptake
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stepped care CBT-IExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Web-based cognitive-behavioral therapy for insomnia (CBT-I)
2013
N/A
~180

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
107,037 Total Patients Enrolled
3 Trials studying Insomnia
458 Patients Enrolled for Insomnia
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,625 Total Patients Enrolled
1 Trials studying Insomnia
111 Patients Enrolled for Insomnia
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,297 Total Patients Enrolled
6 Trials studying Insomnia
821 Patients Enrolled for Insomnia

Media Library

Web-based cognitive-behavioral therapy for insomnia (CBT-I) Clinical Trial Eligibility Overview. Trial Name: NCT04817163 — N/A
Insomnia Research Study Groups: Stepped care CBT-I
Insomnia Clinical Trial 2023: Web-based cognitive-behavioral therapy for insomnia (CBT-I) Highlights & Side Effects. Trial Name: NCT04817163 — N/A
Web-based cognitive-behavioral therapy for insomnia (CBT-I) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817163 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been inducted into this trial thus far?

"Affirmative. According to clinicaltrials.gov, this experiment is presently recruiting new test subjects having been first published on December 13th 2019 and subsequently updated on July 18th 2022. To date, 120 people have registered at 1 site to take part in the study."

Answered by AI

Are there any current opportunities to participate in this clinical trial?

"Confirmed. Clinicaltrials.gov databases indicate that this research, first published on December 13th 2019, is actively enrolling participants. The study seeks to recruit 120 individual from one medical site."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Implementation of CBT-I in Cancer Clinics
Josée Savard 2019. "Implementation of CBT-I in Cancer Clinics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817163.
All > Sleep Disorders
~22 spots leftby Apr 2025
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