Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Insomnia Severity Index (ISI) at Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Insomnia Severity Index (ISI) at Baseline
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks(8 weeks from baseline)
- Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20(20 weeks from baseline)
- Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8(8 weeks from baseline)
- Pittsburgh Sleep Quality Index (PSQI) at Baseline(Baseline)
- The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8(8 weeks from baseline)
- The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20(20 weeks from baseline)
- The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8(8 weeks from baseline)
- The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8(8 weeks from baseline)
- The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20(20 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) Minutes Wake After Sleep Onset at Baseline(Baseline)
- The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8(8 weeks from baseline)
- The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks(20 weeks from baseline)
- The Consensus Sleep Diary (CSD) Baseline Total Sleep Time(Baseline)
- The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline(Baseline)
- Brief Pain Inventory (BPI) at Baseline(Baseline)
- Brief Pain Inventory (BPI) Change From Baseline at Week 8(8 weeks from baseline)
- The Brief Pain Inventory (BPI) Change From Baseline at Week 20(20 weeks from baseline)
- The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20(20 weeks from baseline)
- Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline(Baseline)
- Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8(8 weeks from baseline)
- Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20(20 weeks from baseline)
- Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8(8 weeks from baseline)
- Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20(20 weeks)
- Global Physical Health Scale (PROMIS® Global 10) at Baseline(Baseline)
- Global Mental Health Scale (PROMIS® Global 10) at Baseline(Baseline)
- Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline(Baseline)
- Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline(Baseline)
- Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8(8 weeks from baseline)
- Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20(20 weeks from baseline)
- Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8(8 weeks from baseline)
- Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20(20 weeks from baseline)
- Treatment Expectancy Scale: Expectancy for CBT-I Treatment(Baseline)
- Treatment Expectancy Scale: Expectancy for Acupuncture Treatment(Baseline)