Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026048
• Other study ID #: 20200427
• Secondary ID: PJT 162428
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will answer the question of whether treating insomnia using Cognitive Behavior Therapy for Insomnia (CBT-I) can improve perceived cognitive impairment (PCI) in cancer survivors compared to a waitlist control group. The investigators will recruit 124 people with insomnia and cognitive complaints who have completed cancer treatment at least 6 months prior to the study.

Description:

The investigators will conduct a randomized controlled trial of immediate treatment with CBT-I compared to a delayed treatment group with 124 cancer survivors who have completed primary treatment at least 6 months prior and report PCI and insomnia. Participants who are randomized to the immediate treatment group will receive CBT-I over the course of seven weekly one hour sessions, after which the delayed treatment group will receive the intervention. Both groups will complete follow up assessments three and six months after completing treatment. PCI will be assessed using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) as the primary outcome. To provide an objective assessment of cognition, the investigators have included the neurocognitive measures recommended by the International Cognition and Cancer Task Force. Other measures will include fatigue, anxiety, depression, and work productivity. The investigators hypothesize that the online CBT-I group will report significantly greater improvements in perceived cognitive function compared to the waitlist control immediately post-treatment (primary endpoint). The investigators also hypothesize that these improvements will be maintained up at 6-months follow up (secondary endpoint).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 30, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for individuals with non-hematological malignancies:

• Men and women who are easily able to understand and read English
• No current evidence of cancer or clinically stable/inactive disease
• Received and completed all adjuvant treatments at least 6 months prior to study entry to allow for neural stabilization and recovery
• Self-reported PCI as indicated by a score of "sometimes" or higher ("quite a lot" or "always") on at least two out of three questions that assess memory, concentration, and attention
• Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder and have a score of 8 or greater on the Insomnia Severity Index (ISI)
• Have good performance status as indicated by an Eastern Cooperative Oncology Group (ECOG) score of 0-2
• Have high-speed internet connection, Webcam, and are fluent using the internet

Inclusion Criteria for individuals with hematological malignancies:

• Men and women who are easily able to understand and read English
• A diagnosis of a hematological malignancy currently in remission
• Completed cancer treatments including transplant, chemotherapy and/or immunotherapy at least 6 months prior to study entry
• Self-reported PCI as indicated by a score of "sometimes" or higher ("quite a lot" or "always") on at least two out of three questions that assess memory, concentration, and attention
• Meet the DSM-5 criteria for insomnia disorder and have a score of 8 or greater on the Insomnia Severity Index
• Have good performance status as indicated by an ECOG score of 0-2
• Have high-speed internet connection, webcam, and are fluent using the internet

Exclusion Criteria for individuals with and without hematological malignancies:

• Another sleep disorder, besides insomnia, that is not adequately treated (ie:

untreated obstructive sleep apnea)

• The presence of another psychological disorder that is not currently stable and/or would impair the ability to participate in the study
• A major sensory deficit (e.g. blindness)
• A neurologic or major medical condition known to affect cognitive function (e.g., Parkinson's)
• A history of cranial radiation
• A history of any other condition that may affect cognitive functioning (e.g., traumatic brain injury)
• Previous experience with CBT-I

Other considerations:

• Participants will not be excluded for using psychotropic medication prior to study entry (e.g. antidepressants) provided that the dose was not recently altered (stable over the previous 6 weeks)
• Considering the potential for prescription of medications to help with sleep (e.g. hypnotics, sedatives, and antidepressants) within the cancer population, medication use throughout the study will be tracked and adjusted for in the statistical analysis

Related Conditions & MeSH terms

• Cancer
• Cognitive Dysfunction
• Cognitive Impairment
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behaviour Therapy for Insomnia (CBT-I)
CBT-I is a manualized multi-component intervention that includes sleep restriction, stimulus control, cognitive restructuring, relaxation training, and sleep hygiene.

Locations

Country	Name	City	State
Canada	Memorial University of Newfoundland	St. John's	Newfoundland and Labrador

Sponsors (2)

Lead Sponsor	Collaborator
Memorial University of Newfoundland	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) version 3	The FACT-Cog will be used as the measure of perceived cognitive impairment. It is a 37-item questionnaire with four cognitive subscales: perceived cognitive impairments, impact on quality of life, comments from others, and perceived cognitive abilities. Responses range from 0, ''never,'' to 4, ''several times a day,'' in the previous 7 days and negatively worded items are reverse scored to create subscale scores. Scores on the PCI subscale can range from 0 to 72 points, with a higher score indicative of better self-reported cognitive functioning and quality of life. A change of 5.9-points has been established as clinically meaningful change on the FACT-Cog PCI subscale	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	The Insomnia Severity Index (ISI)	The ISI is designed to specifically assess the severity of insomnia symptoms, the impact on daytime functioning, and the amount of associated distress. The ISI has 7 questions, which are summed to compute a total score. The range of the ISI is 0-28 with the higher the value, the more severe the insomnia severity.	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	Sleep efficiency measured by The Consensus Sleep Diary (CSD)	Sleep efficiency is the percentage of time spent asleep while in bed. It is calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes). The unit of measure is a percentage and is averaged over the whole week for the total sleep efficiency score.	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	Sleep-onset latency measured by The Consensus Sleep Diary (CSD)	The sleep diary will be used to calculate sleep-onset latency, which is the length of time that it takes to accomplish the transition from full wakefulness to sleep. The unit of measure is minutes and is averaged over the whole week for the total sleep onset latency score.	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	Wake after sleep onset measured by The Consensus Sleep Diary (CSD)	The sleep diary will be used to calculate wake after sleep onset, which refers to periods of wakefulness occurring after defined sleep onset. The score is reported in minutes and is averaged over the whole week for the total wake after sleep onset.	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	Total sleep time measured by The Consensus Sleep Diary (CSD):	The sleep diary will be used to calculate total sleep time. The score is reported in minutes and is averaged over the whole week for the total sleep time.	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	Hospital Anxiety and Depression Scale (HADS)	Anxiety and Depression will be measured using the HADS, which is a 14-item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Scores range from 0-21 with below 7 indicating a non-case and the higher the score indicates greater symptom severity.	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)	Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.	Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary	The Hopkins Verbal Learning Test-Revised (HVLT-R)	The HVLT-R is a brief assessment of verbal learning and memory (immediate recall, delayed recall, delayed recognition). When scoring the HVLT-R, the three learning trials are combined to calculate a total recall score; the delayed recall trial creates the delayed recall score; the retention (%) score is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. These scores are then converted to an age-based T score.	Change from Baseline to Week 8, 3 month follow up, 6 month follow up
Secondary	The Controlled Oral Word Association Test (COWAT)	The COWAT is a measure of verbal fluency, cognitive and motor speed, cognitive flexibility, strategy utilization, suppression of interference, and response inhibition. The test score is the total number of different words produced for all three letters.	Change from Baseline to Week 8, 3 month follow up, 6 month follow up
Secondary	The Digit Span	The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scale (WMS). Part a of digit span (the forward span) captures attention efficiency and capacity, and part b (the backward span) is an executive task dependent on working memory. The Digit Span subtest will be scored as one summary value. The unit of measure is the total recall.	Change from Baseline to Week 8, 3 month follow up, 6 month follow up
Secondary	The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A)	The BRIEF-A is composed of 75 items within nine non-overlapping theoretically and empirically derived clinical scales. It has 2 broad indexes (Behavioural Regulation and Metacognition), an overall summary score, and three validity scales (Negativity, Inconsistency, and Infrequency). T scores (M = 50, SD = 10) (transformations of the raw scale scores) are used to interpret the individual's level of executive functioning. Traditionally, T scores at or above 65 are considered clinically significant.	Change from Baseline to Week 8, 3 month follow up, 6 month follow up
Secondary	The Work Productivity and Activity Impairment (WPAI)	The WPAI questionnaire was developed for the purpose of collecting productivity loss data within clinical trials and is suitable for direct translation into a monetary figure. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Change from Baseline to Week 8, 3 month follow up, 6 month follow up
Secondary	Credibility/Expectancy Questionnaire (CEQ)	This questionnaire is designed to measure treatment expectancy and rationale credibility in studies with clinical outcomes. Scores for each question range from 1-9 or 0%-100% with higher scores indicating greater treatment expectancy and credibility.	Baseline