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Implementation of CBT-I in Cancer Clinics

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ClinicalTrials.gov Identifier: NCT04817163
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society (CCS)
Information provided by (Responsible Party):
Josée Savard, CHU de Quebec-Universite Laval

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.


Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I) Behavioral: Professionally-administered booster face-to-face CBT-I sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of a Stepped Care Cognitive-Behavioral Therapy for Insomnia in Routine Cancer Care
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : June 1, 2022

Arm Intervention/treatment
Experimental: Stepped care CBT-I Behavioral: 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.
Other Name: Self-administered

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.




Primary Outcome Measures :
  1. Implementation (organizational) measures [ Time Frame: Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months ]
    Referral, enrolment and completion rates to the stepped care CBT-I in each clinical setting.

  2. 1) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    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.

  3. 2) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    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.

  4. 3) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep onset latency (SOL) = Time to sleep after lights out.

  5. 4) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    Change in daily sleep diary parameters from pre- to post-intervention: Change in wake after sleep onset (WASO) = Summation of nocturnal awakenings.

  6. 5) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    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.

  7. 6) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    Change in daily sleep diary parameters from pre- to post-intervention: Change in total sleep time (TST) = Time in bed minus total wake time.

  8. 7) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    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.

  9. 8) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    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.

  10. 9) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    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.

  11. 10) Efficiency (patients) measures [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    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.

  12. 1) Fidelity to the treatment protocol (psychologists) [ Time Frame: Throughout the active phase, up to 20 months ]
    Self-assessed adherence to the CBT-I protocol (%)

  13. 2) Fidelity to the treatment protocol (psychologists) [ Time Frame: Throughout the active phase, up to 20 months ]
    Perceived self-efficiency in using CBT-I protocol (%)


Secondary Outcome Measures :
  1. 1) Possible predictors of a better program uptake [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) for patient; Through study completion (an average of 24 months) for clinicians ]
    Clinicians and patients' demographics (e.g., age, sex)

  2. 2) Possible predictors of a better program uptake [ Time Frame: Through study completion, an average of 24 months ]
    Administrators' and clinicians' attitude towards empirically-based treatments (Evidence-Based Practice Attitudes Scale (EBPAS; 15 items)): Scores obtained range from 0 to 60.

  3. 3) Possible predictors of a better program uptake [ Time Frame: Through study completion, an average of 24 months ]
    Stress at work (Workplace Stress Scale (WSS; 8 items)): Scores obtained range from 8 to 40.

  4. 4) Possible predictors of a better program uptake [ Time Frame: Through study completion, an average of 24 months ]
    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).

  5. 5) Possible predictors of a better program uptake [ Time Frame: Through study completion, an average of 24 months ]
    Clinicians' CBT expertise (number of years of experience with CBT)

  6. 6) Possible predictors of a better program uptake [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    Patients' familiarity with the Internet (Internet Evaluation and Utility Questionnaire (IEUQ; 15 items)): Patients respond to the questions on a 5-point likert scale from "not at all" (0) to "very" (4), with 2 open-ended items asking patients to identify "most helpful" and "least helpful" parts of the web program.

  7. 7) Possible predictors of a better program uptake [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
    Health literacy (Brief Health Literacy Screening Tool (BRIEF; 4 items)): Each item ranges from 1 to 5 and total scores range from 4 to 20.

  8. Possible moderating treatment effect by some of the participants' characteristics (e.g., age, sex, cancer site). [ Time Frame: Pre-treatment (at recruitment) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817163


Contacts
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Contact: Josée Savard, Ph.D. 418-525-4444 ext 20622 josee.savard@psy.ulaval.ca

Locations
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Canada
Centre de recherche de L'Hôtel-Dieu de Québec Recruiting
Québec, Canada, G1R 2J6
Contact: Catherine Filion, M.A.    1-418-525-4444 ext 20618    catherine.filion@crchudequebec.ulaval.ca   
Principal Investigator: Josée Savard, Ph.D.         
Sub-Investigator: Marie-Pierre Gagnon, Ph.D.         
Sub-Investigator: Aude Caplette-Gingras, Ph.D.         
Sub-Investigator: Lynda Bélanger, Ph.D.         
Sub-Investigator: Charles M. Morin, Ph.D.         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society (CCS)
Investigators
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Principal Investigator: Josée Savard, Ph.D. Centre de recherche du CHU de Québec-Université Laval
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Responsible Party: Josée Savard, Researcher, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT04817163    
Other Study ID Numbers: IC118713
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josée Savard, CHU de Quebec-Universite Laval:
Insomnia
Cancer
Cognitive-behavioral therapy
Stepped care model
Self-administered treatment
Web-based intervention
Implementation
Cost-effectiveness
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders