Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy

Conditions
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Insomnia, Cancer

Intervention / Treatment
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* Other: Acupuncture
* Other: Cognitive Behavior Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture Group<br>In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. | Other: Acupuncture<br> <br> |
| Active Comparator: CBT-I Group<br>In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. | Other: Cognitive Behavior Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks from baseline | 
| 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. | Baseline | 
| 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. | 8 weeks from baseline | 
| 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. | 20 weeks | 
| 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. | 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. | 8 weeks 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. | 20 weeks 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. | 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. | 8 weeks 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. | 20 weeks 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. | Baseline | 
| 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, chemotherapy, radiation, Acupuncture, 16-947