Healing Touch or Guided Imagery In Treating Pain, Fatigue, Nausea, and Anxiety in Patients Undergoing Chemotherapy

NCT ID: NCT01553578

Last Updated: 2018-07-05

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

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

Brief Summary

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This randomized clinical trial studies healing touch or guided imagery in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided imagery may help treat complications caused by chemotherapy. It is not yet known whether healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy

Detailed Description

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PRIMARY OBJECTIVES:

I. To determine if the provision of healing touch or guided imagery during outpatient chemotherapy is associated with decreased pain, fatigue, nausea and anxiety when compared to standard outpatient treatment protocols.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive 30 minutes of healing touch therapy comprising magnetic clearing, pain drains, hands in motion/hands still and mind clearing.

ARM B: Patients listen to guided imagery audiotapes for 30 minutes

ARM C: Patients receive standard of care.

Conditions

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Anxiety Disorder Fatigue Malignant Neoplasm Nausea and Vomiting Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm A (healing touch therapy)

Patients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing.

Group Type EXPERIMENTAL

questionnaire administration

Intervention Type OTHER

Ancillary studies

therapeutic touch

Intervention Type PROCEDURE

Receive healing touch therapy

management of therapy complications

Intervention Type BEHAVIORAL

Receive healing touch therapy

Arm B (guided imagery)

Patients listen to guided imagery audiotapes for 30 minutes.

Group Type EXPERIMENTAL

questionnaire administration

Intervention Type OTHER

Ancillary studies

management of therapy complications

Intervention Type BEHAVIORAL

Receive guided imagery audiotapes

Arm C (standard care)

Patients receive standard of care.

Group Type ACTIVE_COMPARATOR

questionnaire administration

Intervention Type OTHER

Ancillary studies

standard follow-up care

Intervention Type PROCEDURE

Receive standard care

Interventions

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questionnaire administration

Ancillary studies

Intervention Type OTHER

therapeutic touch

Receive healing touch therapy

Intervention Type PROCEDURE

management of therapy complications

Receive healing touch therapy

Intervention Type BEHAVIORAL

management of therapy complications

Receive guided imagery audiotapes

Intervention Type BEHAVIORAL

standard follow-up care

Receive standard care

Intervention Type PROCEDURE

Other Intervention Names

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healing touch complications of therapy, management of complications of therapy, management of

Eligibility Criteria

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Inclusion Criteria

* Adult patients at the outpatient chemotherapy area will be enrolled without consideration for type of cancer or chemotherapeutic agents to be used
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

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Hodges

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2012-00164

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 97511

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00018805

Identifier Type: -

Identifier Source: org_study_id

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