Hypnotherapy in Treating Chronic Pain in Cancer Survivors

August 16, 2017 updated by: Fred Hutchinson Cancer Center

Hypnosis for Pain Management With Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group I (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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Hypnotherapy
Undergo hypnotherapy
Other Names:
  • Hypnosis
ACTIVE_COMPARATOR: Group II (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.
Other: Questionnaire Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of hypnotherapy determined by structured phone interviews with participants
Time Frame: At week 8
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
Time Frame: Baseline to up to 8 weeks
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
Time Frame: Baseline to up to 8 weeks
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
Time Frame: Baseline to up to 8 weeks
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
Time Frame: Baseline to up to 8 weeks
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
Time Frame: Up to 8 weeks
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)
Time Frame: Baseline to up to 8 weeks
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
Time Frame: Up to 12 months
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
American Nurses Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2016

Primary Completion (ACTUAL)

February 9, 2017

Study Completion (ACTUAL)

August 3, 2017

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (ESTIMATE)

December 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9445 (Other Identifier: CTEP)
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2015-01868 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • T32NR013456 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Questionnaire Administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe