Back to resultsChoosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
Primary Purpose
Insomnia, Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Cognitive Behavior Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring surgery, chemotherapy, radiation, Acupuncture, 16-947
Eligibility Criteria
Inclusion Criteria:
- English-speaking, age ≥ 18 years old
- A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria are not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites.
- Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded).
- A score >7 on our primary outcome (the Insomnia Severity Index)
- A diagnosis of insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5), per the diagnostic interview. According to this nosology, insomnia is defined as dissatisfaction with sleep quality or quantity characterized by difficulty initiating sleep, maintaining sleep, or early morning awakenings that cause significant distress or impairment in daytime functioning and occur at least three nights per week for at least three months despite adequate opportunity for sleep.
- Patients using psychotropic medication (e.g. antidepressants) will remain eligible for study participation provided that the dose was not recently altered (stable over the previous 6-weeks).
- Patients using hypnotics or sedatives will be eligible for study participation. Considering the high use of benzodiazepines within the oncology population, past research has included participants who met diagnostic criteria for insomnia, despite the use of benzodiazepines, and included monitoring of medication use.
Exclusion Criteria:
- Another sleep disorder, other than sleep apnea, that is not adequately treated.
- Previous experience with CBT or acupuncture to treat insomnia
- Currently participating in another acupuncture trial or a trial to treat insomnia
- The presence of another Axis I disorder not in remission
- Employment in a job requiring shift work that would impair the ability to establish a regular sleep schedule
- Patients who are currently taking oral (not including oral sprays/inhalers) or intravenous corticosteroids as part of treatment for cancer or any other condition will be excluded because of the potential of these drugs to induce insomnia
Sites / Locations
- Memorial Sloan Kettering Cancer Center
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Acupuncture Group
CBT-I Group
Arm Description
In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.
In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.
Outcomes
Primary Outcome Measures
Insomnia Severity Index (ISI) at Baseline
The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks
A greater negative value represents improvement in symptoms.
The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks
A greater negative value represents improvement in symptoms.
The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Secondary Outcome Measures
Pittsburgh Sleep Quality Index (PSQI) at Baseline
The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks
A greater negative value represents improvement in symptoms. Please note this is the change in score from baseline at 8 weeks.
The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.
Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks
A greater negative value represents improvement in symptoms. Please note that this is the change in score from baseline to 20 weeks.
The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.
The Consensus Sleep Diary (CSD) Baseline Sleep Onset
The Consensus Sleep Diary (CSD) will be used to calculate sleep onset at baseline. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8
A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 8.
The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20
A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 20.
The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline
The Consensus Sleep Diary (CSD) will be used to calculate wake after sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8
A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 8.
The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks
A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 20.
The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Baseline Total Sleep Time
The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8
A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 8.
The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20
A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 20.
The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline
Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. A higher number indicates better sleep efficiency.
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8
A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 8.
Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20
A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 20.
Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.
Brief Pain Inventory (BPI) at Baseline
Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Brief Pain Inventory (BPI) Change From Baseline at Week 8
A greater negative value represents improvement in symptoms.
Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
The Brief Pain Inventory (BPI) Change From Baseline at Week 20
A greater negative value represents improvement in symptoms.
Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline
The Multidimensional Fatigue Inventory-Short Form (MFSI-SF) is a 30 item self-report measure. Higher scores indicate more fatigue.
A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8
A greater negative value represents improvement in symptoms.
A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20
A greater negative value represents improvement in symptoms.
A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinicao; and 11-21 clinically significant depression/anxiety.
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Global Physical Health Scale (PROMIS® Global 10) at Baseline
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Global Mental Health Scale (PROMIS® Global 10) at Baseline
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Treatment Expectancy Scale: Expectancy for CBT-I Treatment
A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.
Treatment Expectancy Scale: Expectancy for Acupuncture Treatment
A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.
Full Information
NCT ID
NCT02356575
First Posted
February 2, 2015
Last Updated
May 12, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02356575
Brief Title
Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
Official Title
Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Pennsylvania
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to determine which of two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in cancer survivors. The investigator also wants to study the factors that might impact why someone might prefer or do better in one treatment over the other.
Group 1 will get Acupuncture - Acupuncture is an ancient Chinese Technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing.
Group 2 will get Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT-I is a treatment to address behaviors and thoughts that are known to effect problems with sleep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Cancer
Keywords
surgery, chemotherapy, radiation, Acupuncture, 16-947
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Group
Arm Type
Active Comparator
Arm Description
In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.
Arm Title
CBT-I Group
Arm Type
Active Comparator
Arm Description
In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Type
Other
Intervention Name(s)
Cognitive Behavior Therapy
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI) at Baseline
Description
The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Time Frame
At Baseline
Title
Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks
Description
A greater negative value represents improvement in symptoms.
The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Time Frame
8 weeks from baseline
Title
Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks
Description
A greater negative value represents improvement in symptoms.
The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Time Frame
20 weeks from baseline
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI) at Baseline
Description
The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks
Description
A greater negative value represents improvement in symptoms. Please note this is the change in score from baseline at 8 weeks.
The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.
Time Frame
8 weeks from baseline
Title
Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks
Description
A greater negative value represents improvement in symptoms. Please note that this is the change in score from baseline to 20 weeks.
The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.
Time Frame
20 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Baseline Sleep Onset
Description
The Consensus Sleep Diary (CSD) will be used to calculate sleep onset at baseline. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
Baseline
Title
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8
Description
A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 8.
The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
8 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20
Description
A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 20.
The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
20 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline
Description
The Consensus Sleep Diary (CSD) will be used to calculate wake after sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
Baseline
Title
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8
Description
A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 8.
The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
8 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks
Description
A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 20.
The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
20 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Baseline Total Sleep Time
Description
The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
Baseline
Title
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8
Description
A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 8.
The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
8 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20
Description
A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 20.
The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time Frame
20 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline
Description
Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. A higher number indicates better sleep efficiency.
Time Frame
Baseline
Title
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8
Description
A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 8.
Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.
Time Frame
8 weeks from baseline
Title
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20
Description
A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 20.
Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.
Time Frame
20 weeks from baseline
Title
Brief Pain Inventory (BPI) at Baseline
Description
Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Time Frame
Baseline
Title
Brief Pain Inventory (BPI) Change From Baseline at Week 8
Description
A greater negative value represents improvement in symptoms.
Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Time Frame
8 weeks from baseline
Title
The Brief Pain Inventory (BPI) Change From Baseline at Week 20
Description
A greater negative value represents improvement in symptoms.
Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Time Frame
20 weeks from baseline
Title
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline
Description
The Multidimensional Fatigue Inventory-Short Form (MFSI-SF) is a 30 item self-report measure. Higher scores indicate more fatigue.
A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Time Frame
Baseline
Title
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8
Description
A greater negative value represents improvement in symptoms.
A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Time Frame
8 weeks from baseline
Title
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20
Description
A greater negative value represents improvement in symptoms.
A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Time Frame
20 weeks from baseline
Title
Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline
Description
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinicao; and 11-21 clinically significant depression/anxiety.
Time Frame
Baseline
Title
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8
Description
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time Frame
8 weeks from baseline
Title
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20
Description
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time Frame
20 weeks from baseline
Title
Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline
Description
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time Frame
Baseline
Title
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8
Description
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time Frame
8 weeks from baseline
Title
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20
Description
A greater negative value represents improvement in symptoms.
This 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. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time Frame
20 weeks
Title
Global Physical Health Scale (PROMIS® Global 10) at Baseline
Description
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time Frame
Baseline
Title
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
Description
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time Frame
8 weeks from baseline
Title
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
Description
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time Frame
20 weeks from baseline
Title
Global Mental Health Scale (PROMIS® Global 10) at Baseline
Description
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time Frame
Baseline
Title
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
Description
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time Frame
8 weeks from baseline
Title
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
Description
A greater positive value represents improvement in symptoms.
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time Frame
20 weeks from baseline
Title
Treatment Expectancy Scale: Expectancy for CBT-I Treatment
Description
A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.
Time Frame
Baseline
Title
Treatment Expectancy Scale: Expectancy for Acupuncture Treatment
Description
A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking, age ≥ 18 years old
A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria are not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites.
Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded).
A score >7 on our primary outcome (the Insomnia Severity Index)
A diagnosis of insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5), per the diagnostic interview. According to this nosology, insomnia is defined as dissatisfaction with sleep quality or quantity characterized by difficulty initiating sleep, maintaining sleep, or early morning awakenings that cause significant distress or impairment in daytime functioning and occur at least three nights per week for at least three months despite adequate opportunity for sleep.
Patients using psychotropic medication (e.g. antidepressants) will remain eligible for study participation provided that the dose was not recently altered (stable over the previous 6-weeks).
Patients using hypnotics or sedatives will be eligible for study participation. Considering the high use of benzodiazepines within the oncology population, past research has included participants who met diagnostic criteria for insomnia, despite the use of benzodiazepines, and included monitoring of medication use.
Exclusion Criteria:
Another sleep disorder, other than sleep apnea, that is not adequately treated.
Previous experience with CBT or acupuncture to treat insomnia
Currently participating in another acupuncture trial or a trial to treat insomnia
The presence of another Axis I disorder not in remission
Employment in a job requiring shift work that would impair the ability to establish a regular sleep schedule
Patients who are currently taking oral (not including oral sprays/inhalers) or intravenous corticosteroids as part of treatment for cancer or any other condition will be excluded because of the potential of these drugs to induce insomnia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33752446
Citation
Liou KT, Garland SN, Li QS, Sadeghi K, Green J, Autuori I, Orlow I, Mao JJ. Effects of acupuncture versus cognitive behavioral therapy on brain-derived neurotrophic factor in cancer survivors with insomnia: an exploratory analysis. Acupunct Med. 2021 Dec;39(6):637-645. doi: 10.1177/0964528421999395. Epub 2021 Mar 22.
Results Reference
derived
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
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