Healing Touch and Relaxation Therapies in Cervical Cancer Patients

NCT ID: NCT00084123

Last Updated: 2009-07-10

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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2007-04-30

Brief Summary

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The purpose of this study is to evaluate the effects of healing touch and relaxation therapy on cervical cancer patients undergoing chemotherapy and radiation treatment.

Detailed Description

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The side effects of chemotherapy and radiation treatment are often severe and can have devastating effects on the mental and physical well-being of cancer patients. This study will determine whether healing touch and relaxation therapy are effective in minimizing the side effects of chemotherapy and radiation treatment in cervical cancer patients.

Participants in this study will receive weekly chemotherapy and daily radiation treatments for 6 weeks. Participants will be randomly assigned to receive either standard care (SC), SC plus relaxation therapy, or SC plus healing touch therapy. The relaxation therapy consists of progressive muscle relaxation and guided imagery. The healing touch therapy involves an energy-based modality in which health care practitioners stimulate the energy fields surrounding the patient. A physician-completed assessment and measures of immune function will be used to assess the well-being and overall quality of life of participants.

Conditions

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Cervix Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healing Touch

Healing Touch Therapy

Group Type EXPERIMENTAL

Healing Touch Therapy

Intervention Type BEHAVIORAL

Relaxation Therapy

Relaxation Therapy

Group Type ACTIVE_COMPARATOR

Relaxation Therapy

Intervention Type BEHAVIORAL

Standard Care

Standard Care

Group Type PLACEBO_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Standard Care

Interventions

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Healing Touch Therapy

Intervention Type BEHAVIORAL

Relaxation Therapy

Intervention Type BEHAVIORAL

Standard Care

Standard Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Stage Ib1-IVa cervical cancer
* Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics

Exclusion Criteria

* Immunosuppressive disorders
* Use of immunosuppressive medications
* Transplant recipient
* Metastatic or recurrent cervical cancer
* History of any other type of cancer
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Susan K Lutgendorf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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P20AT000756-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00065091

Identifier Type: -

Identifier Source: nct_alias

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