Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
1 other identifier
interventional
160
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
October 2, 2019
CompletedMay 16, 2022
May 1, 2022
2.4 years
February 2, 2015
May 3, 2019
May 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (35)
Pittsburgh Sleep Quality Index (PSQI) at Baseline
Baseline
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks
8 weeks from baseline
Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks
20 weeks from baseline
The Consensus Sleep Diary (CSD) Baseline Sleep Onset
Baseline
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8
8 weeks from baseline
- +30 more secondary outcomes
Study Arms (2)
Acupuncture Group
ACTIVE COMPARATORIn the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.
CBT-I Group
ACTIVE COMPARATORIn the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- University of Pennsylvaniacollaborator
Study Sites (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (4)
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 Jan 23. doi: 10.1007/s10865-025-00621-7. Online ahead of print.
PMID: 41575714DERIVEDCai 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.
PMID: 41170811DERIVEDKwag 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.
PMID: 40896348DERIVEDLiou 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.
PMID: 33752446DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jun Mao, MD, MSCE
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 5, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
May 16, 2022
Results First Posted
October 2, 2019
Record last verified: 2022-05