Hypnotherapy in Treating Chronic Pain in Cancer Survivors

NCT ID: NCT02637297

Last Updated: 2017-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-08

Study Completion Date

2017-08-03

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.

Conditions

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Anxiety Cancer Survivor Chronic Pain Depression Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Study Groups

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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.

Group Type EXPERIMENTAL

Hypnotherapy

Intervention Type PROCEDURE

Undergo hypnotherapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Hypnotherapy

Undergo hypnotherapy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Hypnosis

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

American Nurses Foundation

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Shannon Dorcy

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-01868

Identifier Type: REGISTRY

Identifier Source: secondary_id

9445

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

T32NR013456

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9445

Identifier Type: -

Identifier Source: org_study_id

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