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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23NR017208 | U.S. NIH Grant/Contract | View source | |
| RG1004569 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2021-00201 | Registry Identifier | NCI-CTRP |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants will use the recorded hypnosis intervention (RHI) at home for 28 days. |
|
| Attention Control Group | Active Comparator | Participants will use a recorded relaxation intervention at home for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recorded Hypnosis Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- to Post-treatment (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- to Post-treatment (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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.
Exclusion Criteria for Optional EEG Measurement:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Eaton, RN | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60607 | United States | ||
| Seattle Cancer Care Alliance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39284247 | Derived | Eaton LH, Jang MK, Jensen MP, Heitkemper MM, Doorenbos AZ. Perceptions of the effects of recorded hypnosis and relaxation interventions for cancer survivors with chronic pain. Complement Ther Clin Pract. 2024 Nov;57:101907. doi: 10.1016/j.ctcp.2024.101907. Epub 2024 Sep 12. | |
| 36526937 | Derived | Eaton LH, Jang MK, Jensen MP, Pike KC, Heitkemper MM, Doorenbos AZ. Hypnosis and relaxation interventions for chronic pain management in cancer survivors: a randomized controlled trial. Support Care Cancer. 2022 Dec 17;31(1):50. doi: 10.1007/s00520-022-07498-1. |
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The proposed research will include data from adult cancer survivors with chronic pain. The final data set will include (1) qEEG pattern data, and (2) self-reported demographic and behavioral data from questionnaires and interviews. The final data set will be stripped of individual identifiers prior to release for sharing.
8/31/21 - 8/31/24
The data and associated documentation will be made available to users only under a data-sharing agreement that provides for (a) a commitment to using the data only for research purposes and not to identify any individual participant, (b) a commitment to securing the data using appropriate computer technology, and (c) a commitment to destroying or returning the data after analyses are completed. Such a data-use agreement will be executed through the PI. The database can then be accessed via a secure website, in a format that can be used by a variety of statistical software packages.
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Participants were recruited by phone and during cancer survivor or palliative care clinic visits from February 2019 to August 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants will use the recorded hypnosis intervention (RHI) at home for 28 days. Recorded 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. |
| FG001 | Attention Control Group | Participants will use a recorded relaxation intervention at home for 28 days. Recorded 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypnosis | Participants were asked to use the recorded hypnosis intervention for 28 days. |
| BG001 | Relaxation | Participants were asked to use the recorded relaxation intervention for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention). | Posted | Mean | Standard Deviation | score on a scale | Pre- to Post-treatment (4 weeks) |
|
From baseline to post-treatment (4 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Participants are asked to use the recorded hypnosis intervention for 28 days. |
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We were unable to conduct EEGs throughout the study period due to restrictions at the data collection site during the COVID pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Eaton | University of Washington Bothell | 4253523645 | lineaton@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2019 | Aug 18, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized Controlled Trial
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| Recorded Relaxation Intervention | Behavioral | 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). |
|
| 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. | Pre- to Post-treatment (4 weeks) |
| 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. | Pre- to Post-treatment (4 weeks) |
| 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. | Pre- to Post-treatment (4 weeks) |
| 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. | Pre- to Post-treatment (4 weeks) |
| Pre-treatment |
| 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). | Baseline, 2 weeks, 4 weeks |
| Seattle |
| Washington |
| 98109 |
| United States |
| subject could not meet study logistics |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Stanford Hypnotic Clinical Scale for Adults | The Stanford Hypnotic Clinical Scale for Adults involves a standard hypnotic induction followed by five standard hypnotic suggestions delivered by a member of the research team. Participant responses to the suggestions are coded (yes/no) and responses are summed to create the total scale score, which can range from 0 to 5. A higher score indicates a higher level of hypnotic responsivity. | Mean | Standard Deviation | units on a scale |
|
| Tellegen Absorption Scale | The 34-item multi-dimensional scale measures imaginative involvement and the tendency to become mentally absorbed in everyday activities. The minimum score is 0 and the maximum score is 34. A higher score indicates a higher level of mental absorption. | Mean | Standard Deviation | units on a scale |
|
| Credibility Expectancy Questionnaire | The Credibility Expectancy Questionnaire consists of 6 items using the 0 -10 numeric rating scale to measure ratings of beliefs about how well the treatment might reduce pain. Scores range from 0 to 60 with higher scores indicating greater belief in the treatment's effect in reducing their pain. | Mean | Standard Deviation | units on a scale |
|
| PROMIS®, v.1.0, 1a - Pain Intensity | Patient Reported Outcomes Measurement Information System® (PROMIS®) v.1.0, 1a - Pain Intensity: Average pain intensity was assessed by asking participants to rate their pain intensity on average in the past 7 days using the 0-10 numeric rating scale with 0 = "no pain" and 10 = "worst pain imaginable." | Mean | Standard Deviation | units on a scale |
|
| PROMIS®, Pain Interference SF4v1.1 | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS®, Anxiety SF4v1 | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS®, Depression SF4v1 | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS®, Fatigue SF4v1 | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS®, Sleep Disturbance SF4v1 | 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. | Mean | Standard Deviation | units on a scale |
|
Participants who use the recorded relaxation intervention for 28 days.
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| 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. | Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention). | Posted | Mean | Standard Deviation | score on a scale | Pre- to Post-treatment (4 weeks) |
|
|
|
|
| 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. | Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention). | Posted | Mean | Standard Deviation | score on a scale | Pre- to Post-treatment (4 weeks) |
|
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|
|
| 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. | Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention). | Posted | Mean | Standard Deviation | score on a scale | Pre- to Post-treatment (4 weeks) |
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|
|
| 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. | Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention). | Posted | Mean | Standard Deviation | score on a scale | Pre- to Post-treatment (4 weeks) |
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| 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. | Cancer survivors with chronic pain were randomly assigned to the recorded hypnosis intervention group or the attention control group (recorded relaxation intervention). | Posted | Mean | Standard Deviation | score on a scale | Pre- to Post-treatment (4 weeks) |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment |
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| 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). | Not Posted | Baseline, 2 weeks, 4 weeks | Participants |
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Attention Control Group | Participants are asked to use a recorded relaxation intervention for 28 days. | 0 | 54 | 0 | 54 | 0 | 54 |
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