Chronic Pain
Conditions
Brief summary
Cancer survivors who suffer from chronic pain would benefit from a low-cost, self-management intervention they can use at home. This study will evaluate the efficacy of a recorded hypnosis intervention in reducing chronic pain among cancer survivors and will explore its biological and psychological mechanisms.
Detailed description
The purpose of this randomized controlled trial is to evaluate if a 4-week recorded hypnosis intervention (RHI) works for reducing chronic pain in 100 adult cancer survivors who have completed active treatment. The RHI will be compared to an attention control condition (relaxation recording). qEEG measurement will be obtained while listening to the RHI at weeks 0, 2, and 4 to explore if brain states are related to hypnotic analgesia during the 4-week study period in 20 study participants. The study has the following specific aims: Aim 1: Does the RHI work? Evaluate the efficacy of RHI in reducing self-reported pain intensity (primary outcome), pain interference, anxiety, depression, fatigue and sleep disturbance (secondary outcomes) at 4 weeks compared to the attention control condition (relaxation recording). Hypothesis: RHI will significantly reduce pain intensity, pain interference, anxiety, depression, fatigue, and sleep disturbance at 4 weeks. Aim 2: For whom does the RHI work? Examine if psychological factors (hypnotic suggestibility, mental absorption, treatment outcome expectancy, fear of cancer recurrence, resilience, self-efficacy) influence the relationship between RHI and pain intensity at weeks 0, 2, and 4. Aim 3: How does the RHI work? a. Compare brain activity as measured by electroencephalogram (EEG) in cancer survivors with chronic pain (n=30) receiving the RHI relative to the attention control condition (relaxation recording) at weeks 0, 2, and 4. b. Explore the effects of brain activity on pain intensity at weeks 0, 2, and 4. In addition, structured interviews will be conducted with participants to understand facilitators and barriers associated with undergoing EEG at three time points and perceptions on how the intervention works to reduce pain.
Interventions
BEHAVIORALRecorded Hypnosis Intervention
The RHI consists of four digital recordings developed by the investigator using standardized hypnosis scripts for pain reduction and uploaded to a MP3 player. The scripts were developed for patients with chronic pain and tested by a psychologist who is an expert in hypnosis research. Participants will listen to the recordings daily for 28 days in the prescribed order (4 recordings for 3 days each, and then any recording for the remaining 16 days). The script includes an induction, suggestions for how to access inner resources and manage pain, and post-hypnotic suggestions for permanence of hypnosis benefits and self-hypnosis practice.
BEHAVIORALRecorded Relaxation Intervention
The recorded relaxation intervention consists of four digital recordings developed by the investigator using standardized relaxation scripts and uploaded to a MP3 player. Participants will listen to the recordings daily for 28 days in the prescribed order (4 recordings for 3 days each, and then any recording for the remaining 16 days).
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* self-reporting moderate or higher pain on average during the last week (\> 3 on a 0-10 pain intensity numeric scale) * self-reporting experiencing pain at least half of the days in the past 4 weeks * self-reporting chronic pain related to cancer or its treatment * completed active cancer treatment other than maintenance therapy * being \> 18 years of age * functional fluency in English * mentally and physically able to participate and complete surveys
Exclusion criteria
• has a psychiatric condition or symptoms (i.e., diagnosis of paranoid schizophrenia or active paranoid delusional thoughts, as determined via a telephone or in-person screening assessment) that would interfere with study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | Pre- to Post-treatment (4 weeks) | The Patient Reported Outcomes Measurement Information System® (PROMIS®) v.1.0, 1a - Pain Intensity; minimum value 0, maximum value 10; a lower score indicates a better outcome. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference | Pre- to Post-treatment (4 weeks) | The Patient Reported Outcomes Measurement Information System® (PROMIS®) Pain Interference Short Form 4v1.1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less pain interference. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported. |
| Change in Anxiety | Pre- to Post-treatment (4 weeks) | The Patient Reported Outcomes Measurement Information System® (PROMIS®) Anxiety Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less anxiety. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported. |
| Change in Depression | Pre- to Post-treatment (4 weeks) | The Patient Reported Outcomes Measurement Information System® (PROMIS®) Depression Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less depression. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported. |
| Change in Fatigue | Pre- to Post-treatment (4 weeks) | The Patient Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less fatigue. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported. |
| Change in Sleep Disturbance | Pre- to Post-treatment (4 weeks) | The Patient Reported Outcomes Measurement Information System® (PROMIS®) Sleep Disturbance Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less sleep disturbance. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Credibility and Expectancy | Pre-treatment | Credibility and Expectancy Questionnaire; minimum score = 0, maximum score = 60; a higher score indicates a better outcome. Pre-treatment (baseline) scores were calculated for hypnosis participants with a clinically meaningful improvement in pain intensity (change from pre-treatment to post-treatment of at least 2 points) and for hypnosis participants who did not have a clinically meaningful improvement in pain intensity. |
| Change in Brain Activity | Baseline, 2 weeks, 4 weeks | EEG measurement; measures brain activity while using study intervention. Participants underwent an EEG while listening to the assigned study intervention at three time points: pre-treatment (baseline), mid-treatment (2 weeks), and post-treatment (4 weeks). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited by phone and during cancer survivor or palliative care clinic visits from February 2019 to August 2021.
Participants by arm
| Arm | Count |
|---|---|
| Hypnosis Participants were asked to use the recorded hypnosis intervention for 28 days. | 55 |
| Relaxation Participants were asked to use the recorded relaxation intervention for 28 days. | 54 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | subject could not meet study logistics | 3 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Relaxation | Total | Hypnosis |
|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 12.2 | 55.62 years STANDARD_DEVIATION 12.9 | 54.5 years STANDARD_DEVIATION 13.6 |
| Credibility Expectancy Questionnaire | 55.33 units on a scale STANDARD_DEVIATION 22.01 | 50.54 units on a scale STANDARD_DEVIATION 23.69 | 45.96 units on a scale STANDARD_DEVIATION 24.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 76 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 26 Participants | 11 Participants |
| PROMIS®, Anxiety SF4v1 | 58.71 units on a scale STANDARD_DEVIATION 9.53 | 59.13 units on a scale STANDARD_DEVIATION 8.88 | 59.53 units on a scale STANDARD_DEVIATION 8.26 |
| PROMIS®, Depression SF4v1 | 53.76 units on a scale STANDARD_DEVIATION 8.9 | 53.82 units on a scale STANDARD_DEVIATION 8.68 | 53.89 units on a scale STANDARD_DEVIATION 8.54 |
| PROMIS®, Fatigue SF4v1 | 58.36 units on a scale STANDARD_DEVIATION 9.44 | 58.18 units on a scale STANDARD_DEVIATION 8.98 | 58.01 units on a scale STANDARD_DEVIATION 8.58 |
| PROMIS®, Pain Interference SF4v1.1 | 62.16 units on a scale STANDARD_DEVIATION 6.58 | 61.89 units on a scale STANDARD_DEVIATION 6.51 | 61.62 units on a scale STANDARD_DEVIATION 6.49 |
| PROMIS®, Sleep Disturbance SF4v1 | 54.36 units on a scale STANDARD_DEVIATION 9.51 | 54.99 units on a scale STANDARD_DEVIATION 8.55 | 55.61 units on a scale STANDARD_DEVIATION 7.52 |
| PROMIS®, v.1.0, 1a - Pain Intensity | 6.02 units on a scale STANDARD_DEVIATION 1.86 | 6.04 units on a scale STANDARD_DEVIATION 1.84 | 6.05 units on a scale STANDARD_DEVIATION 1.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 24 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 35 Participants | 70 Participants | 35 Participants |
| Sex: Female, Male Female | 43 Participants | 89 Participants | 46 Participants |
| Sex: Female, Male Male | 11 Participants | 20 Participants | 9 Participants |
| Stanford Hypnotic Clinical Scale for Adults | 2.81 units on a scale STANDARD_DEVIATION 1.39 | 2.80 units on a scale STANDARD_DEVIATION 1.4 | 2.78 units on a scale STANDARD_DEVIATION 1.44 |
| Tellegen Absorption Scale | 14.52 units on a scale STANDARD_DEVIATION 8.6 | 15.10 units on a scale STANDARD_DEVIATION 8.18 | 15.67 units on a scale STANDARD_DEVIATION 7.78 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
Primary
Change in Pain Intensity
The Patient Reported Outcomes Measurement Information System® (PROMIS®) v.1.0, 1a - Pain Intensity; minimum value 0, maximum value 10; a lower score indicates a better outcome. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Time frame: Pre- to Post-treatment (4 weeks)
Population: Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Pain Intensity | -1.61 score on a scale | Standard Deviation 1.88 |
| Attention Control Group | Change in Pain Intensity | -1.35 score on a scale | Standard Deviation 1.54 |
Comparison: Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain intensity than cancer survivors assigned to the relaxation intervention.p-value: 0.809ANCOVA
Secondary
Change in Anxiety
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Anxiety Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less anxiety. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Time frame: Pre- to Post-treatment (4 weeks)
Population: Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Anxiety | -3.07 score on a scale | Standard Deviation 6.11 |
| Attention Control Group | Change in Anxiety | -3.61 score on a scale | Standard Deviation 6.8 |
Comparison: Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in anxiety than cancer survivors assigned to the relaxation intervention.p-value: 0.029ANCOVA
Secondary
Change in Depression
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Depression Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less depression. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Time frame: Pre- to Post-treatment (4 weeks)
Population: Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Depression | -1.75 score on a scale | Standard Deviation 5.35 |
| Attention Control Group | Change in Depression | -2.74 score on a scale | Standard Deviation 6.81 |
Comparison: Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in depression than cancer survivors assigned to the relaxation intervention.p-value: 0.236ANCOVA
Secondary
Change in Fatigue
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less fatigue. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Time frame: Pre- to Post-treatment (4 weeks)
Population: Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Fatigue | -2.66 score on a scale | Standard Deviation 5.65 |
| Attention Control Group | Change in Fatigue | -2.67 score on a scale | Standard Deviation 7.39 |
Comparison: Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in fatigue than cancer survivors assigned to the relaxation intervention.p-value: 0.904ANCOVA
Secondary
Change in Pain Interference
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Pain Interference Short Form 4v1.1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less pain interference. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Time frame: Pre- to Post-treatment (4 weeks)
Population: Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Pain Interference | -3.75 score on a scale | Standard Deviation 5.38 |
| Attention Control Group | Change in Pain Interference | -3.03 score on a scale | Standard Deviation 6.81 |
Comparison: Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain interference than cancer survivors assigned to the relaxation intervention.p-value: 0.369ANCOVA
Secondary
Change in Sleep Disturbance
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Sleep Disturbance Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less sleep disturbance. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Time frame: Pre- to Post-treatment (4 weeks)
Population: Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Sleep Disturbance | -3.96 score on a scale | Standard Deviation 7.34 |
| Attention Control Group | Change in Sleep Disturbance | -3.31 score on a scale | Standard Deviation 9.49 |
Comparison: Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in sleep disturbance than cancer survivors assigned to the relaxation intervention.p-value: 0.936ANCOVA
Other Pre-specified
Change in Brain Activity
EEG measurement; measures brain activity while using study intervention. Participants underwent an EEG while listening to the assigned study intervention at three time points: pre-treatment (baseline), mid-treatment (2 weeks), and post-treatment (4 weeks).
Time frame: Baseline, 2 weeks, 4 weeks
Other Pre-specified
Treatment Credibility and Expectancy
Credibility and Expectancy Questionnaire; minimum score = 0, maximum score = 60; a higher score indicates a better outcome. Pre-treatment (baseline) scores were calculated for hypnosis participants with a clinically meaningful improvement in pain intensity (change from pre-treatment to post-treatment of at least 2 points) and for hypnosis participants who did not have a clinically meaningful improvement in pain intensity.
Time frame: Pre-treatment
Population: Cancer survivors with chronic pain who use the recorded hypnosis intervention for 28 days. Participants in the Attention Control Group were not assessed for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Treatment Credibility and Expectancy | 53.81 score on a scale | Standard Deviation 23.55 |
| Attention Control Group | Treatment Credibility and Expectancy | 36 score on a scale | Standard Deviation 24.7 |
Comparison: Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention who experience a clinically meaningful improvement in pain intensity will not have a significantly higher pre-treatment treatment credibility and expectancy score than non-improvers.p-value: 0.02t-test, 2 sided