InsomniaNCT02356575
Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
A study testing Acupuncture and Cognitive Behavior Therapy in people with Insomnia and Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupuncture and Cognitive Behavior Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Being tested
- Acupuncture, Cognitive Behavior Therapy
- Keywords
- surgery, chemotherapy, radiation, Acupuncture, 16-947
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Cognitive Behavior TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Active comparator | In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Receives: Other: Acupuncture |
| CBT-I Group | Active comparator | In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Receives: Other: Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 20 weeks from baseline
Secondary outcomes (35)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, MSCE, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356575
- Sponsor's protocol ID
- 16-947
- Status last verified
- May 2022
- First submitted
- 2 Feb 2015
- Last updated
- 16 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Li Y, Liou KT, Schofield E, Atkinson TM, Mao JJ. Novel bayesian nonparametric unsupervised learning approach to precision symptom management in cancer survivors: a re-analysis of a comparative effectiveness trial. J Behav Med. 2026 Apr;49(2):372-385. doi: 10.1007/s10865-025-00621-7. Epub 2026 Jan 23.
PubMed 41575714Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811Kwag E, Li X, Garland S, Bryl K, Taylor L, Li QS, Amann L, Mao JJ, McConnell KM. Acupuncture versus cognitive behavioral therapy for anxiety among cancer survivors with insomnia: An exploratory analysis of a randomized clinical trial. Integr Med Res. 2025 Dec;14(4):101213. doi: 10.1016/j.imr.2025.101213. Epub 2025 Aug 7.
PubMed 40896348Liou 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.
PubMed 33752446
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
- ClinicalTrials.gov ID
- NCT02356575
- Acronym / sponsor ID
- 16-947
- Keywords
- surgery, chemotherapy, radiation, Acupuncture, 16-947
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Feb 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Active comparator | Other: AcupunctureIn the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. |
| CBT-I Group | Active comparator | Other: Cognitive Behavior TherapyIn the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Other | Acupuncture Group |
| Cognitive Behavior Therapy | Other | CBT-I Group |
Primary outcome
Insomnia Severity Index (ISI) at Baseline
Time frame: 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
Time frame: 8 weeks from baseline
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
Time frame: 20 weeks from baseline
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.
35 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) at Baseline
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks
Time frame: 8 weeks from baseline
Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks
Time frame: 20 weeks from baseline
The Consensus Sleep Diary (CSD) Baseline Sleep Onset
Time frame: Baseline
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8
Time frame: 8 weeks from baseline
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20
Time frame: 20 weeks from baseline
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline
Time frame: Baseline
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8
Time frame: 8 weeks from baseline
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks
Time frame: 20 weeks from baseline
The Consensus Sleep Diary (CSD) Baseline Total Sleep Time
Time frame: Baseline
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8
Time frame: 8 weeks from baseline
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20
Time frame: 20 weeks from baseline
The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline
Time frame: Baseline
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8
Time frame: 8 weeks from baseline
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20
Time frame: 20 weeks from baseline
Brief Pain Inventory (BPI) at Baseline
Time frame: Baseline
Brief Pain Inventory (BPI) Change From Baseline at Week 8
Time frame: 8 weeks from baseline
The Brief Pain Inventory (BPI) Change From Baseline at Week 20
Time frame: 20 weeks from baseline
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline
Time frame: Baseline
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8
Time frame: 8 weeks from baseline
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20
Time frame: 20 weeks from baseline
Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8
Time frame: 8 weeks from baseline
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20
Time frame: 20 weeks from baseline
Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8
Time frame: 8 weeks from baseline
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20
Time frame: 20 weeks
Global Physical Health Scale (PROMIS® Global 10) at Baseline
Time frame: Baseline
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
Time frame: 8 weeks from baseline
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
Time frame: 20 weeks from baseline
Global Mental Health Scale (PROMIS® Global 10) at Baseline
Time frame: Baseline
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
Time frame: 8 weeks from baseline
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
Time frame: 20 weeks from baseline
Treatment Expectancy Scale: Expectancy for CBT-I Treatment
Time frame: Baseline
Treatment Expectancy Scale: Expectancy for Acupuncture Treatment
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41575714Li Y, Liou KT, Schofield E, Atkinson TM, Mao JJ. Novel bayesian nonparametric unsupervised learning approach to precision symptom management in cancer survivors: a re-analysis of a comparative effectiveness trial. J Behav Med. 2026 Apr;49(2):372-385. doi: 10.1007/s10865-025-00621-7. Epub 2026 Jan 23.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Derived from this study: PubMed 40896348Kwag E, Li X, Garland S, Bryl K, Taylor L, Li QS, Amann L, Mao JJ, McConnell KM. Acupuncture versus cognitive behavioral therapy for anxiety among cancer survivors with insomnia: An exploratory analysis of a randomized clinical trial. Integr Med Res. 2025 Dec;14(4):101213. doi: 10.1016/j.imr.2025.101213. Epub 2025 Aug 7.
- Derived from this study: PubMed 33752446Liou 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Mao, MD, MSCE principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Cognitive Behavior Therapy in people with Insomnia and Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) at Baseline (time frame: At Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02356575, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.