Implementation of CBT-I in Cancer Clinics

NCT ID: NCT04817163

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2025-05-30

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.

Conditions

Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stepped care CBT-I

Group Type: EXPERIMENTAL

Web-based cognitive-behavioral therapy for insomnia (CBT-I)

Intervention Type: BEHAVIORAL

Each 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

Intervention Type: BEHAVIORAL

Patients 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.

Interventions

Web-based cognitive-behavioral therapy for insomnia (CBT-I)

Each 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.

Intervention Type: BEHAVIORAL

Professionally-administered booster face-to-face CBT-I sessions

Patients 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Self-administered

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Cancer Society (CCS)

OTHER

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Josée Savard

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josée Savard, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du CHU de Québec-Université Laval

Locations

Centre de recherche de L'Hôtel-Dieu de Québec

Québec, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Josée Savard, Ph.D.

Role: CONTACT

josee.savard@psy.ulaval.ca

418-525-4444 ext. 20622

Facility Contacts

Emilie Godin, B.A.

Role: primary

emilie.godin@crchudequebec.ulaval.ca

1-418-525-4444 ext. 67428

Other Identifiers

IC118713

Identifier Type: -

Identifier Source: org_study_id