Clinical trial NCT02356575: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Cancer
Keywords: surgery
chemotherapy
radiation
Acupuncture
16-947
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2015-02-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Insomnia Severity Index (ISI) at Baseline
timeFrame: At Baseline
measure: Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks
timeFrame: 8 weeks from baseline
measure: Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks
timeFrame: 20 weeks from baseline
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) at Baseline
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks
timeFrame: 8 weeks from baseline
measure: Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks
timeFrame: 20 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Baseline Sleep Onset
timeFrame: Baseline
measure: The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline
timeFrame: Baseline
measure: The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks
timeFrame: 20 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Baseline Total Sleep Time
timeFrame: Baseline
measure: The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline
timeFrame: Baseline
measure: The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: Brief Pain Inventory (BPI) at Baseline
timeFrame: Baseline
measure: Brief Pain Inventory (BPI) Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: The Brief Pain Inventory (BPI) Change From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline
timeFrame: Baseline
measure: Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20
timeFrame: 20 weeks
measure: Global Physical Health Scale (PROMIS® Global 10) at Baseline
timeFrame: Baseline
measure: Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: Global Mental Health Scale (PROMIS® Global 10) at Baseline
timeFrame: Baseline
measure: Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
timeFrame: 8 weeks from baseline
measure: Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
timeFrame: 20 weeks from baseline
measure: Treatment Expectancy Scale: Expectancy for CBT-I Treatment
timeFrame: Baseline
measure: Treatment Expectancy Scale: Expectancy for Acupuncture Treatment
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
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.