Implementation of CBT-I in Cancer Clinics
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Sequential
Treatments tested in this trial
Web-based cognitive-behavioral therapy for insomnia (CBT-I)
BehavioralEach week, the patients first have to read written information on the website (www.insomnet.ca), and then watch a video capsule (duration between 5 and 20 min each). Patients complete their daily sleep diary electronically on the website and the content is interactive. It includes the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content.
Professionally-administered booster face-to-face CBT-I sessions
BehavioralPatients who obtain an ISI score of 8 and more after completing the web-based CBT-I are "stepped up" and offered to receive up to three 50-min booster sessions of CBT-I offered individually by a psychologist (if needed). Remitted patients (good sleepers; ISI score lower than 8) will receive no further treatment.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Stepped care CBT-IExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Implementation (organizational) measures
Referral, enrolment and completion rates to the stepped care CBT-I in each clinical setting.
Time frame
Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months2
1) Change in Insomnia Severity Index Scores
Change in Insomnia Severity Index Scores from pre- to post-intervention. The ISI is a 7-item questionnaire designed to evaluate insomnia severity. A score greater than or equal to 8 indicates the presence of insomnia symptoms.
Time frame
Pre-treatment and post-treatment (6-8 weeks later)3
2) Change in sleep efficiency (SE)
Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep efficiency (SE) index (%) = Total sleep time/total time spent in bed X 100.
Time frame
Pre-treatment and post-treatment (6-8 weeks later)4
3) Change in sleep onset latency (SOL)
Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep onset latency (SOL) = Time to sleep after lights out.
Time frame
Pre-treatment and post-treatment (6-8 weeks later)Secondary outcomes
1
1) Demographic characteristics
Clinicians and patients' demographics (e.g., age, sex)
Time frame
Pre-treatment and post-treatment (6-8 weeks later) for patient; Through study completion (an average of 24 months) for clinicians2
2) Evidence-Based Practice Attitudes Scale (EBPAS)
Administrators' and clinicians' attitude towards empirically-based treatments (Evidence-Based Practice Attitudes Scale (EBPAS; 15 items)): Scores obtained range from 0 to 60.
Time frame
Through study completion, an average of 24 months3
3) Workplace Stress Scale (WSS)
Stress at work (Workplace Stress Scale (WSS; 8 items)): Scores obtained range from 8 to 40.
Time frame
Through study completion, an average of 24 months4
4) Organizational Readiness for Implementing Change (ORIC)
Attitude towards change (Organizational Readiness for Implementing Change (ORIC; 12 items)): Participants rated the hospital's readiness for implementation on 12 items using a 5-point ordinal scale that ranged from "disagree" (1) to "agree" (5).
Time frame
Through study completion, an average of 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
CHU de Quebec-Universite Laval
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Canadian Cancer Society (CCS)
Collaborator
Source ClinicalTrials.gov