N/A
Completed N=160
Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy
Source: ClinicalTrials.gov NCT02356575 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Insomnia Severity Index (ISI) at Baseline — 17.6; 18.5 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) at Baseline |
17.6; 18.5 | — |
| PRIMARY Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks |
-8.31; -10.91 | — |
| PRIMARY Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks |
-8.59; -11.12 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) at Baseline |
11.8; 12.1 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks |
-4.39; -5.90 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks |
-4.62; -5.84 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Baseline Sleep Onset |
32.1; 47.1 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8 |
-10.80; -27.13 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20 |
-10.91; -24.37 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline |
58.0; 53.6 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8 |
-26.89; -35.83 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks |
-22.01; -29.51 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Baseline Total Sleep Time |
346.1; 340.8 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8 |
61.81; 35.01 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20 |
50.71; 45.23 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline |
73.2; 72.1 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8 |
0.11; 0.16 | — |
| SECONDARY The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20 |
0.10; 0.13 | — |
| SECONDARY Brief Pain Inventory (BPI) at Baseline |
2.4; 2.1 | — |
| SECONDARY Brief Pain Inventory (BPI) Change From Baseline at Week 8 |
-0.49; 0.00 | — |
| SECONDARY The Brief Pain Inventory (BPI) Change From Baseline at Week 20 |
-0.46; -0.35 | — |
| SECONDARY Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline |
19.8; 21.9 | — |
| SECONDARY Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8 |
-10.82; -12.48 | — |
| SECONDARY Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20 |
-12.20; -11.19 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline |
7.8; 7.8 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8 |
-2.21; -1.93 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20 |
-1.94; -1.83 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline |
4.6; 5.1 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8 |
-1.06; -1.45 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20 |
-0.91; -1.22 | — |
| SECONDARY Global Physical Health Scale (PROMIS® Global 10) at Baseline |
45.2; 43.4 | — |
| SECONDARY Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 |
2.19; 3.73 | — |
| SECONDARY Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 |
3.29; 4.49 | — |
| SECONDARY Global Mental Health Scale (PROMIS® Global 10) at Baseline |
45.0; 44.1 | — |
| SECONDARY Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 |
3.34; 3.39 | — |
| SECONDARY Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 |
4.08; 3.29 | — |
| SECONDARY Treatment Expectancy Scale: Expectancy for CBT-I Treatment |
12.8; 13.2 | — |
| SECONDARY Treatment Expectancy Scale: Expectancy for Acupuncture Treatment |
13.3; 13.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02356575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.