Implementation of CBT-I in Cancer Clinics

NCT04817163 | Recruiting

• 1 other identifier: IC118713
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Insomnia; Cancer; Cognitive-behavioral therapy; Stepped care model; Self-administered treatment; Web-based intervention; Implementation; Cost-effectiveness

Outcome Measures

Primary Outcomes (13)

• Implementation (organizational) measures

  Referral, enrolment and completion rates to the stepped care CBT-I in each clinical setting.

  Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months

• 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.

  Pre-treatment and post-treatment (6-8 weeks later)

• 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.

  Pre-treatment and post-treatment (6-8 weeks later)

• 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.

  Pre-treatment and post-treatment (6-8 weeks later)

• 4) Change in wake after sleep onset (WASO)

  Change in daily sleep diary parameters from pre- to post-intervention: Change in wake after sleep onset (WASO) = Summation of nocturnal awakenings.

  Pre-treatment and post-treatment (6-8 weeks later)

• 5) Change in total wake time (TWT)

  Change in daily sleep diary parameters from pre- to post-intervention: Change in total wake time (TWT) = Summation of SOL, WASO, and early morning awakening.

  Pre-treatment and post-treatment (6-8 weeks later)

• 6) Change in total sleep time (TST)

  Change in daily sleep diary parameters from pre- to post-intervention: Change in total sleep time (TST) = Time in bed minus total wake time.

  Pre-treatment and post-treatment (6-8 weeks later)

• 7) Hospital Anxiety and Depression Scale (HADS)

  Change scores from pre to post-intervention: Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire comprising 7 items assessing depression and 7 items assessing anxiety. Scores obtained for each subscale range from 0 to 21.

  Pre-treatment and post-treatment (6-8 weeks later)

• 8) Fatigue Symptom Inventory (FSI)

  Change scores from pre to post-intervention: Fatigue Symptom Inventory (FSI): A 14-item questionnaire measuring perceived fatigue. Each item is rated on an 11-point Likert scale, ranging from 0 to 10. A higher score indicates a higher level of fatigue or interference or a longer duration of fatigue.

  Pre-treatment and post-treatment (6-8 weeks later)

• 9) The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  Change scores from pre to post-intervention: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): A 30-item questionnaire. Scores are transformed to give a score ranging from 0 to 100.

  Pre-treatment and post-treatment (6-8 weeks later)

• 10) Satisfaction with Life Scale (SWLS)

  Change scores from pre to post-intervention: Satisfaction with Life Scale (SWLS): A 5-item questionnaire (Likert scale from 1 to 7) designed to measure global cognitive judgments of satisfaction with one's life.

  Pre-treatment and post-treatment (6-8 weeks later)

• 1) Psychologists' adherence to the protocol

  Psychologists' self-assessed adherence to the CBT-I protocol (%)

  Throughout the active phase, up to 20 months

• 2) Psychologists' perceived self-efficiency

  Psychologists' perceived self-efficiency in using CBT-I protocol (%)

  Throughout the active phase, up to 20 months

Secondary Outcomes (8)

• 1) Demographic characteristics

  Pre-treatment and post-treatment (6-8 weeks later) for patient; Through study completion (an average of 24 months) for clinicians

• 2) Evidence-Based Practice Attitudes Scale (EBPAS)

  Through study completion, an average of 24 months

• 3) Workplace Stress Scale (WSS)

  Through study completion, an average of 24 months

• 4) Organizational Readiness for Implementing Change (ORIC)

  Through study completion, an average of 24 months

• 5) Clinicians expertise

  Through study completion, an average of 24 months

Study Arms (1)

Stepped care CBT-I

EXPERIMENTAL

Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I); Behavioral: Professionally-administered booster face-to-face CBT-I sessions

Interventions

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

Also known as: Self-administered

Stepped care CBT-I

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

Stepped care CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

Centre de recherche de L'Hôtel-Dieu de Québec

Québec, G1R 2J6, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Josée Savard, Ph.D.

  Centre de recherche du CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josée Savard, Ph.D.

CONTACT

418-525-4444; josee.savard@psy.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 26, 2021
• Study Start: December 13, 2019
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)