Trial Outcomes & Findings for Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy (NCT NCT02356575)

NCT ID: NCT02356575

Last Updated: 2022-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: At Baseline
• Results posted on: 2022-05-16

Participant Flow

Participant milestones

Measure	Acupuncture Group In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Overall Study STARTED	80	80
Overall Study COMPLETED	80	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy	Total n=160 Participants Total of all reporting groups
Age, Continuous	62.3 years n=5 Participants	60.7 years n=7 Participants	61.5 years n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	32 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	75 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	27 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	52 Participants n=7 Participants	113 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	80 Participants n=5 Participants	80 Participants n=7 Participants	160 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Insomnia Severity Index (ISI) at Baseline	17.6 score on a scale Standard Deviation 4.1	18.5 score on a scale Standard Deviation 4.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks	-8.31 units on a scale Interval -9.36 to -7.26	-10.91 units on a scale Interval -11.97 to -9.85

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks	-8.59 units on a scale Interval -9.65 to -7.55	-11.12 units on a scale Interval -12.19 to -10.06

SECONDARY outcome

Timeframe: Baseline

The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Pittsburgh Sleep Quality Index (PSQI) at Baseline	11.8 units on a scale Standard Deviation 3.2	12.1 units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater negative value represents improvement in symptoms. Please note this is the change in score from baseline at 8 weeks.

The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks	-4.39 units on a scale Interval -5.1 to -3.67	-5.90 units on a scale Interval -6.61 to -5.18

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater negative value represents improvement in symptoms. Please note that this is the change in score from baseline to 20 weeks.

The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a "poor" sleeper. Overall score ranges from 0 to 21.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks	-4.62 units on a scale Interval -5.33 to -3.91	-5.84 units on a scale Interval -6.56 to -5.13

SECONDARY outcome

Timeframe: Baseline

The Consensus Sleep Diary (CSD) will be used to calculate sleep onset at baseline. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Baseline Sleep Onset	32.1 minutes Standard Deviation 29.3	47.1 minutes Standard Deviation 62.1

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 8.

The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8	-10.80 minutes Interval -16.46 to -5.14	-27.13 minutes Interval -33.12 to -21.14

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 20.

The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20	-10.91 minutes Interval -16.7 to -5.13	-24.37 minutes Interval -30.36 to -18.38

SECONDARY outcome

Timeframe: Baseline

The Consensus Sleep Diary (CSD) will be used to calculate wake after sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline	58.0 minutes Standard Error 38.8	53.6 minutes Standard Error 42.1

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 8.

The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8	-26.89 minutes Interval -34.16 to -19.61	-35.83 minutes Interval -43.51 to -28.16

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 20.

The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks	-22.01 minutes Interval -29.45 to -14.58	-29.51 minutes Interval -37.16 to -21.87

SECONDARY outcome

Timeframe: Baseline

The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Baseline Total Sleep Time	346.1 minutes Standard Deviation 82.1	340.8 minutes Standard Deviation 99.2

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 8.

The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8	61.81 minutes Interval 45.79 to 77.84	35.01 minutes Interval 18.12 to 51.91

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 20.

The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20	50.71 minutes Interval 34.39 to 67.03	45.23 minutes Interval 28.33 to 62.12

SECONDARY outcome

Timeframe: Baseline

Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. A higher number indicates better sleep efficiency.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline	73.2 percentage of efficiency Standard Deviation 13.5	72.1 percentage of efficiency Standard Deviation 18.3

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 8.

Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8	0.11 percentage change Interval 0.08 to 0.13	0.16 percentage change Interval 0.13 to 0.18

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 20.

Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20	0.10 percentage change Interval 0.07 to 0.12	0.13 percentage change Interval 0.1 to 0.16

SECONDARY outcome

Timeframe: Baseline

Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Brief Pain Inventory (BPI) at Baseline	2.4 units on a scale Standard Deviation 2.4	2.1 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater negative value represents improvement in symptoms.

Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Brief Pain Inventory (BPI) Change From Baseline at Week 8	-0.49 units on a scale Interval -0.81 to -0.16	0.00 units on a scale Interval -0.33 to 0.33

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater negative value represents improvement in symptoms.

Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
The Brief Pain Inventory (BPI) Change From Baseline at Week 20	-0.46 units on a scale Interval -0.79 to -0.14	-0.35 units on a scale Interval -0.68 to -0.02

SECONDARY outcome

Timeframe: Baseline

The Multidimensional Fatigue Inventory-Short Form (MFSI-SF) is a 30 item self-report measure. Higher scores indicate more fatigue.

A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline	19.8 units on a scale Standard Deviation 21.3	21.9 units on a scale Standard Deviation 22.3

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater negative value represents improvement in symptoms.

A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8	-10.82 units on a scale Interval -13.94 to -7.7	-12.48 units on a scale Interval -15.69 to -9.27

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater negative value represents improvement in symptoms.

A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20	-12.20 score on MFSI-F Interval -15.32 to -9.08	-11.19 score on MFSI-F Interval -14.38 to -8.0

SECONDARY outcome

Timeframe: Baseline

This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinicao; and 11-21 clinically significant depression/anxiety.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline	7.8 units on a scale Standard Deviation 4.0	7.8 units on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater negative value represents improvement in symptoms.

This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8	-2.21 units on a scale Interval -2.82 to -1.6	-1.93 units on a scale Interval -2.56 to -1.3

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater negative value represents improvement in symptoms.

This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20	-1.94 units on a scale Interval -2.55 to -1.33	-1.83 units on a scale Interval -2.46 to -1.2

SECONDARY outcome

Timeframe: Baseline

This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline	4.6 units on a scale Standard Deviation 3.1	5.1 units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater negative value represents improvement in symptoms.

This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8	-1.06 units on a scale Interval -1.57 to -0.55	-1.45 units on a scale Interval -1.98 to -0.92

SECONDARY outcome

Timeframe: 20 weeks

A greater negative value represents improvement in symptoms.

This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20	-0.91 units on a scale Interval -1.42 to -0.4	-1.22 units on a scale Interval -1.75 to -0.69

SECONDARY outcome

Timeframe: Baseline

The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Global Physical Health Scale (PROMIS® Global 10) at Baseline	45.2 units on a scale Standard Deviation 8.4	43.4 units on a scale Standard Deviation 8.7

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater positive value represents improvement in symptoms.

The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8	2.19 units on a scale Interval 0.92 to 3.46	3.73 units on a scale Interval 2.44 to 5.02

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater positive value represents improvement in symptoms.

The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20	3.29 units on a scale Interval 2.02 to 4.56	4.49 units on a scale Interval 3.2 to 5.78

SECONDARY outcome

Timeframe: Baseline

The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Global Mental Health Scale (PROMIS® Global 10) at Baseline	45.0 units on a scale Standard Deviation 8.0	44.1 units on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: 8 weeks from baseline

A greater positive value represents improvement in symptoms.

The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8	3.34 units on a scale Interval 1.99 to 4.69	3.39 units on a scale Interval 2.02 to 4.76

SECONDARY outcome

Timeframe: 20 weeks from baseline

A greater positive value represents improvement in symptoms.

The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20	4.08 units on a scale Interval 2.73 to 5.43	3.29 units on a scale Interval 2.04 to 4.78

SECONDARY outcome

Timeframe: Baseline

A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Treatment Expectancy Scale: Expectancy for CBT-I Treatment	12.8 units on a scale Standard Deviation 3.5	13.2 units on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline

A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.

Outcome measures

Measure	Acupuncture Group n=80 Participants In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 Participants In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
Treatment Expectancy Scale: Expectancy for Acupuncture Treatment	13.3 units on a scale Standard Deviation 4.0	13.2 units on a scale Standard Deviation 3.2

Adverse Events

Acupuncture Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

CBT-I Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acupuncture Group n=80 participants at risk In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks. Acupuncture	CBT-I Group n=80 participants at risk In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks. Cognitive Behavior Therapy
General disorders Soreness at needling site	6.2% 5/80 • 1 year	0.00% 0/80 • 1 year
Nervous system disorders Dizziness	2.5% 2/80 • 1 year	0.00% 0/80 • 1 year
Nervous system disorders Drowsiness	0.00% 0/80 • 1 year	2.5% 2/80 • 1 year
General disorders Fatigue	0.00% 0/80 • 1 year	2.5% 2/80 • 1 year
Injury, poisoning and procedural complications Bruising at needling site	1.2% 1/80 • 1 year	0.00% 0/80 • 1 year
Nervous system disorders Headache	0.00% 0/80 • 1 year	1.2% 1/80 • 1 year
General disorders Itchiness at needling site	1.2% 1/80 • 1 year	0.00% 0/80 • 1 year
General disorders Pain at needling site	1.2% 1/80 • 1 year	0.00% 0/80 • 1 year

Additional Information

Dr. Jun Mao, MD, MSCE

Memorial Sloan Kettering Cancer Center

Phone: 646-888-0866

Email: maoj@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place