Hypnotherapy in Treating Chronic Pain in Cancer Survivors

Study Overview
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Brief Summary
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This randomized pilot clinical trial studies hypnotherapy in treating chronic pain in cancer survivors. Hypnotherapy is a state of concentration and focused attention which can provide more control over the experience of acute and chronic pain and its impact and may provide comfort, maximize function, and improve quality of life in cancer survivors.

Detailed Description
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PRIMARY OBJECTIVES: I. To test the feasibility (recruitment, attrition, adherence, logistical issues) of delivering the hypnosis (hypnotherapy) intervention to cancer survivors with chronic pain. II. To evaluate the acceptability of the hypnosis intervention among cancer survivors with chronic pain. III. To explore preliminary efficacy (estimate effect size) of hypnosis in relieving pain and improving associated anxiety and functional performance at 4 weeks and 8 weeks compared to a wait-list control. OUTLINE: Participants are randomized to 1 of 2 groups. IMMEDIATE INTERVENTION GROUP: Participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks. WAIT-LIST CONTROL GROUP: At week 5, participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks.

Official Title
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Hypnosis for Pain Management With Cancer Survivors

Conditions
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Anxiety, Cancer Survivor, Chronic Pain, Depression, Sleep Disorder

Intervention / Treatment
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* Procedure: Hypnotherapy
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-report of moderate or higher pain on average during the last week (> 3 on a 0-10 pain intensity numeric scale) Completed active cancer treatment other than maintenance therapy >= 3 months ago Functional fluency in English Mentally and physically able to participate and complete surveys over the phone Exclusion Criteria: Chronic pain is not cancer-related

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (immediate intervention group)<br>Participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks. | Procedure: Hypnotherapy<br>* Undergo hypnotherapy<br>* Other names: Hypnosis;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (wait-list control group)<br>At week 5, participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks. | Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of hypnotherapy determined by structured phone interviews with participants | Transcribed interview data and open-ended responses from the pre- post-Intervention Questionnaire will be organized in ATLAS.ti. Content analysis will be used to understand the hypnosis experience. Consensus on key ideas and concepts will be obtained by the Lead Sub-Investigator and research assistant after reading and coding each transcript separately. | At week 8 | 
| Change in beliefs on how well the treatment might work, as measured by the Credibility/Expectancy Questionnaire | To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for | Baseline to up to 8 weeks | 
| Change in imaginative involvement as measured by the Tellegen Absorption Scale | To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for | Baseline to up to 8 weeks | 
| Change in pain and anxiety, as measured using the patient diary | To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for | Baseline to up to 8 weeks | 
| Change in pain and anxiety, as measured using the Pre- Post-Intervention Questionnaire | To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for | Baseline to up to 8 weeks | 
| Change in pain-associated anxiety, measured using the Pain Catastrophizing Scale | To evaluate effects of intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time and group) & 1 interaction effect (time X group). Interaction between group x time will tell if groups change differentially (whether intervention moderates change in outcome). Within wait-list, O2 & O3 will be compared (paired t-test) to see if wait-list replicates immediate group's results. Within immediate group, sustained effects of post-intervention results will be assessed by testing for change across time to O3. During | Up to 8 weeks | 
| Change in Patient Reported Outcomes Measurement Information System-29 scores (measures function, anxiety, depression, fatigue, sleep, and pain interference and intensity) | To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for | Baseline to up to 8 weeks | 
| Feasibility of delivering hypnotherapy in terms of recruitment, attrition, adherence, and logistical issues | A Consort flow diagram will be maintained to record the number of patients who were invited to participate in the study, number of patients who declined to participate and reasons why, number of patients who did not complete the study and reasons why, and adherence to using the intervention. Descriptive statistics (frequency counts, percentages) will be used to analyze the study recruitment, enrollment, and attrition data. | Up to 12 months | 
| Patient demographics, as measured by the Demographic Questionnaire | Demographic variables will be analyzed using descriptive and inferential statistics. In order to examine variability and estimate effect sizes, the analysis needed in a larger trial will be modeled. Baseline demographic and dependent variables for the immediate and wait-list condition groups will be compared with Chi-square or independent t-tests. | Baseline |