Clinical trial NCT04817163: Implementation of CBT-I in Cancer Clinics
Official title: Implementation of a Stepped Care Cognitive-Behavioral Therapy for Insomnia in Routine Cancer Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Cancer
Cognitive-behavioral therapy
Stepped care model
Self-administered treatment
Web-based intervention
Implementation
Cost-effectiveness
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Cancer Society (CCS)
First posted: 2021-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* have received a diagnosis of non-metastatic cancer (any type)
* to be aged 18 years and older
* to be readily able to read and understand French or English
* having the minimum cognitive abilities to read, understand and memorize information
* having access to Internet

Exclusion Criteria:

* having a psychological comorbidity needing clinical attention (e.g., major depressive disorder)
* having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia)
* having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)

Primary outcomes:
measure: Implementation (organizational) measures
timeFrame: Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months
measure: 1) Change in Insomnia Severity Index Scores
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 2) Change in sleep efficiency (SE)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 3) Change in sleep onset latency (SOL)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 4) Change in wake after sleep onset (WASO)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 5) Change in total wake time (TWT)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 6) Change in total sleep time (TST)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 7) Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 8) Fatigue Symptom Inventory (FSI)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 9) The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 10) Satisfaction with Life Scale (SWLS)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 1) Psychologists' adherence to the protocol
timeFrame: Throughout the active phase, up to 20 months
measure: 2) Psychologists' perceived self-efficiency
timeFrame: Throughout the active phase, up to 20 months
Secondary outcomes:
measure: 1) Demographic characteristics
timeFrame: Pre-treatment and post-treatment (6-8 weeks later) for patient; Through study completion (an average of 24 months) for clinicians
measure: 2) Evidence-Based Practice Attitudes Scale (EBPAS)
timeFrame: Through study completion, an average of 24 months
measure: 3) Workplace Stress Scale (WSS)
timeFrame: Through study completion, an average of 24 months
measure: 4) Organizational Readiness for Implementing Change (ORIC)
timeFrame: Through study completion, an average of 24 months
measure: 5) Clinicians expertise
timeFrame: Through study completion, an average of 24 months
measure: 6) Internet Evaluation and Utility Questionnaire (IEUQ)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: 7) Brief Health Literacy Screening Tool (BRIEF)
timeFrame: Pre-treatment and post-treatment (6-8 weeks later)
measure: Possible moderating treatment effect
timeFrame: Pre-treatment (at recruitment)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche de L'Hôtel-Dieu de Québec
Study officials:
affiliation: Centre de recherche du CHU de Québec-Université Laval
name: Josée Savard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: