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

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ClinicalTrials.gov Identifier: NCT02356575
Recruitment Status : Active, not recruiting
First Posted : February 5, 2015
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.


Condition or disease Intervention/treatment Phase
Insomnia Cancer Other: Acupuncture Other: Cognitive Behavior Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
Study Start Date : February 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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



Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356575


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Pennsylvania
Investigators
Principal Investigator: Jun Mao, MD, MSCE Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02356575     History of Changes
Other Study ID Numbers: 16-947
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
surgery
chemotherapy
radiation
Acupuncture
16-947

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders