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Self-Management Interventions for Chronic Pain Relief With Cancer Survivors
NA trial testing Recorded Hypnosis Intervention in Chronic Pain in 109 participants. Completed in 31 August 2021.
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 109 |
| Start date | 21 February 2019 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 2 locations across United States |
University of Washington
Adults 18 to 90, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | -1.61 | ± 1.88 |
| Attention Control Group | -1.35 | ± 1.54 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | -3.75 | ± 5.38 |
| Attention Control Group | -3.03 | ± 6.81 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | -3.07 | ± 6.11 |
| Attention Control Group | -3.61 | ± 6.80 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | -1.75 | ± 5.35 |
| Attention Control Group | -2.74 | ± 6.81 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | -2.66 | ± 5.65 |
| Attention Control Group | -2.67 | ± 7.39 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | -3.96 | ± 7.34 |
| Attention Control Group | -3.31 | ± 9.49 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Hypnosis Improvers | 53.81 | ± 23.55 |
| Hypnosis Non-Improvers | 36 | ± 24.7 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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