Trial Outcomes & Findings for Self-Management Interventions for Chronic Pain Relief With Cancer Survivors (NCT NCT03867760)
NCT ID: NCT03867760
Last Updated: 2022-11-17
Results Overview
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.
COMPLETED
NA
109 participants
Pre- to Post-treatment (4 weeks)
2022-11-17
Participant Flow
Participants were recruited by phone and during cancer survivor or palliative care clinic visits from February 2019 to August 2021.
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
|
Overall Study
COMPLETED
|
49
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
subject could not meet study logistics
|
3
|
3
|
Baseline Characteristics
Self-Management Interventions for Chronic Pain Relief With Cancer Survivors
Baseline characteristics by cohort
| Measure |
Hypnosis
n=55 Participants
Participants were asked to use the recorded hypnosis intervention for 28 days.
|
Relaxation
n=54 Participants
Participants were asked to use the recorded relaxation intervention for 28 days.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
55.62 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 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
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Stanford Hypnotic Clinical Scale for Adults
|
2.78 units on a scale
STANDARD_DEVIATION 1.44 • n=5 Participants
|
2.81 units on a scale
STANDARD_DEVIATION 1.39 • n=7 Participants
|
2.80 units on a scale
STANDARD_DEVIATION 1.40 • n=5 Participants
|
|
Tellegen Absorption Scale
|
15.67 units on a scale
STANDARD_DEVIATION 7.78 • n=5 Participants
|
14.52 units on a scale
STANDARD_DEVIATION 8.60 • n=7 Participants
|
15.10 units on a scale
STANDARD_DEVIATION 8.18 • n=5 Participants
|
|
Credibility Expectancy Questionnaire
|
45.96 units on a scale
STANDARD_DEVIATION 24.55 • n=5 Participants
|
55.33 units on a scale
STANDARD_DEVIATION 22.01 • n=7 Participants
|
50.54 units on a scale
STANDARD_DEVIATION 23.69 • n=5 Participants
|
|
PROMIS®, v.1.0, 1a - Pain Intensity
|
6.05 units on a scale
STANDARD_DEVIATION 1.83 • n=5 Participants
|
6.02 units on a scale
STANDARD_DEVIATION 1.86 • n=7 Participants
|
6.04 units on a scale
STANDARD_DEVIATION 1.84 • n=5 Participants
|
|
PROMIS®, Pain Interference SF4v1.1
|
61.62 units on a scale
STANDARD_DEVIATION 6.49 • n=5 Participants
|
62.16 units on a scale
STANDARD_DEVIATION 6.58 • n=7 Participants
|
61.89 units on a scale
STANDARD_DEVIATION 6.51 • n=5 Participants
|
|
PROMIS®, Anxiety SF4v1
|
59.53 units on a scale
STANDARD_DEVIATION 8.26 • n=5 Participants
|
58.71 units on a scale
STANDARD_DEVIATION 9.53 • n=7 Participants
|
59.13 units on a scale
STANDARD_DEVIATION 8.88 • n=5 Participants
|
|
PROMIS®, Depression SF4v1
|
53.89 units on a scale
STANDARD_DEVIATION 8.54 • n=5 Participants
|
53.76 units on a scale
STANDARD_DEVIATION 8.90 • n=7 Participants
|
53.82 units on a scale
STANDARD_DEVIATION 8.68 • n=5 Participants
|
|
PROMIS®, Fatigue SF4v1
|
58.01 units on a scale
STANDARD_DEVIATION 8.58 • n=5 Participants
|
58.36 units on a scale
STANDARD_DEVIATION 9.44 • n=7 Participants
|
58.18 units on a scale
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
PROMIS®, Sleep Disturbance SF4v1
|
55.61 units on a scale
STANDARD_DEVIATION 7.52 • n=5 Participants
|
54.36 units on a scale
STANDARD_DEVIATION 9.51 • n=7 Participants
|
54.99 units on a scale
STANDARD_DEVIATION 8.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Intervention Group
n=49 Participants
Participants who use the recorded hypnosis intervention for 28 days.
|
Attention Control Group
n=46 Participants
Participants who use the recorded relaxation intervention for 28 days.
|
|---|---|---|
|
Change in Pain Intensity
|
-1.61 score on a scale
Standard Deviation 1.88
|
-1.35 score on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Intervention Group
n=49 Participants
Participants who use the recorded hypnosis intervention for 28 days.
|
Attention Control Group
n=46 Participants
Participants who use the recorded relaxation intervention for 28 days.
|
|---|---|---|
|
Change in Pain Interference
|
-3.75 score on a scale
Standard Deviation 5.38
|
-3.03 score on a scale
Standard Deviation 6.81
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Intervention Group
n=49 Participants
Participants who use the recorded hypnosis intervention for 28 days.
|
Attention Control Group
n=46 Participants
Participants who use the recorded relaxation intervention for 28 days.
|
|---|---|---|
|
Change in Anxiety
|
-3.07 score on a scale
Standard Deviation 6.11
|
-3.61 score on a scale
Standard Deviation 6.80
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Intervention Group
n=49 Participants
Participants who use the recorded hypnosis intervention for 28 days.
|
Attention Control Group
n=46 Participants
Participants who use the recorded relaxation intervention for 28 days.
|
|---|---|---|
|
Change in Depression
|
-1.75 score on a scale
Standard Deviation 5.35
|
-2.74 score on a scale
Standard Deviation 6.81
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Intervention Group
n=49 Participants
Participants who use the recorded hypnosis intervention for 28 days.
|
Attention Control Group
n=46 Participants
Participants who use the recorded relaxation intervention for 28 days.
|
|---|---|---|
|
Change in Fatigue
|
-2.66 score on a scale
Standard Deviation 5.65
|
-2.67 score on a scale
Standard Deviation 7.39
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Intervention Group
n=49 Participants
Participants who use the recorded hypnosis intervention for 28 days.
|
Attention Control Group
n=46 Participants
Participants who use the recorded relaxation intervention for 28 days.
|
|---|---|---|
|
Change in Sleep Disturbance
|
-3.96 score on a scale
Standard Deviation 7.34
|
-3.31 score on a scale
Standard Deviation 9.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=27 Participants
Participants who use the recorded hypnosis intervention for 28 days.
|
Attention Control Group
n=22 Participants
Participants who use the recorded relaxation intervention for 28 days.
|
|---|---|---|
|
Treatment Credibility and Expectancy
|
53.81 score on a scale
Standard Deviation 23.55
|
36 score on a scale
Standard Deviation 24.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2 weeks, 4 weeksEEG 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).
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group
Attention Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place