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出境医 / 临床实验 / Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Insomnia Cognitive Impairment Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I) Not Applicable

Detailed 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).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Cognitive Behaviour Therapy for Insomnia (CBT-I)
Participants will receive individualized CBT-I delivered by video-conferencing over the course of eight weeks.
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.

Experimental: Waitlist Control Group
Participants in the waitlist control group will be required to monitor their sleep with sleep diaries for 7 weeks. They will receive CBT-I delivered by video-conferencing immediately after the waiting period.
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.

Outcome Measures
Primary Outcome Measures :
  1. The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) version 3 [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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


Secondary Outcome Measures :
  1. The Insomnia Severity Index (ISI) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.

  2. Sleep efficiency measured by The Consensus Sleep Diary (CSD) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.

  3. Sleep-onset latency measured by The Consensus Sleep Diary (CSD) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.

  4. Wake after sleep onset measured by The Consensus Sleep Diary (CSD) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.

  5. Total sleep time measured by The Consensus Sleep Diary (CSD): [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.

  6. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.

  7. Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.

  8. The Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.

  9. The Controlled Oral Word Association Test (COWAT) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.

  10. The Digit Span [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.

  11. The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.

  12. The Work Productivity and Activity Impairment (WPAI) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.

  13. Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: Baseline ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sheila N Garland, PhD 709-864-4897 sheila.garland@mun.ca

Locations
Layout table for location information
Canada, Newfoundland and Labrador
Memorial University of Newfoundland Recruiting
St. John's, Newfoundland and Labrador, Canada, A1C 5S7
Contact: Sheila N Garland, PhD    709-864-4897    sheila.garland@mun.ca   
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
Layout table for investigator information
Principal Investigator: Sheila N Garland, PhD Memorial University of Newfoundland
Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) version 3 [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) version 3 [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
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. The total score for the FACT-Cog can range from 0 to 148 points, with a higher score indicative of better self-reported cognitive functioning. ***
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
  • The Insomnia Severity Index (ISI) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Sleep efficiency measured by The Consensus Sleep Diary (CSD) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Sleep-onset latency measured by The Consensus Sleep Diary (CSD) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Wake after sleep onset measured by The Consensus Sleep Diary (CSD) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Total sleep time measured by The Consensus Sleep Diary (CSD): [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) [ Time Frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Controlled Oral Word Association Test (COWAT) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Digit Span [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Work Productivity and Activity Impairment (WPAI) [ Time Frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: Baseline ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • The Mini-Mental State Examination (MMSE) [ Time Frame: Baseline ]
    The MMSE is a method used for assessing cognitive mental state. The total score range from 0-30 and a score lower than 24 suggests the presence of severe cognitive impairments.
  • The Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: Baseline ]
    The CEQ measures how credible the treatment appears to be and how much the participant believes that the therapy will help improve their functioning. The CEQ has a total of 6 questions four of which are answered on a scale ranging from 1 (not at all) to 9 (very much), and two on a scale of 0 (not at all) to 100% (very much), with higher scores indicating greater credibility/expectancy. The questions will be standardized and averaged to form a total score. **
  • Sleep efficiency measured by Actigraphy [ Time Frame: Baseline, Week 8 ]
    Actigraphy measures sleep efficiency based on motor activity. 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.
  • Sleep latency measured by Actigraphy [ Time Frame: Baseline, Week 8 ]
    Actigraphy measures sleep latency based on motor activity. Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep averaged across 7 days. The unit of measure is minutes.
  • Total sleep time measured by Actigraphy [ Time Frame: Baseline, Week 8 ]
    Actigraphy measures total sleep time based on motor activity. Total sleep time is averaged across 7 days and the unit of measure is minutes.
  • Wake after Sleep Onset measured by Actigraphy [ Time Frame: Baseline, Week 8 ]
    Actigraphy measures amount of time awake after sleep onset based on motor activity. Wake after sleep onset averaged across 7 days and the unit of measure is minutes.
  • The Insomnia Severity Index (ISI) [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Sleep efficiency measured by The Consensus Sleep Diary (CSD) [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Sleep-onset latency measured by The Consensus Sleep Diary (CSD) [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Wake after sleep onset measured by The Consensus Sleep Diary (CSD) [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Total sleep time measured by The Consensus Sleep Diary (CSD): [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) [ Time Frame: Baseline, Week 4, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Baseline, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Controlled Oral Word Association Test (COWAT) [ Time Frame: Baseline, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Digit Span [ Time Frame: Baseline,Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A) [ Time Frame: Baseline, Week 8, 3 month follow up, 6 month follow up ]
    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.
  • The Work Productivity and Activity Impairment (WPAI) [ Time Frame: Baseline, Week 8, 3 month follow up, 6 month follow up ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors
Official Title  ICMJE A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors
Brief 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.
Detailed 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Insomnia
  • Cognitive Impairment
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Cognitive Behaviour Therapy for Insomnia (CBT-I)
    Participants will receive individualized CBT-I delivered by video-conferencing over the course of eight weeks.
    Intervention: Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)
  • Experimental: Waitlist Control Group
    Participants in the waitlist control group will be required to monitor their sleep with sleep diaries for 7 weeks. They will receive CBT-I delivered by video-conferencing immediately after the waiting period.
    Intervention: Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2020)
124
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
162
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sheila N Garland, PhD 709-864-4897 sheila.garland@mun.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026048
Other Study ID Numbers  ICMJE 20200427
PJT 162428 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sheila Garland, Memorial University of Newfoundland
Study Sponsor  ICMJE Memorial University of Newfoundland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sheila N Garland, PhD Memorial University of Newfoundland
PRS Account Memorial University of Newfoundland
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP