Healing Touch and Relaxation Therapies in Cervical Cancer Patients

Phase 2

Completed

• Conditions: Cervix Neoplasms
• Interventions: Behavioral: Healing Touch Therapy; Behavioral: Relaxation Therapy; Behavioral: Standard Care

• Registration Number: NCT00084123
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2004-06-07
• Study First Submitted QC: 2004-06-07
• Study First Posted: 2004-06-08
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-09
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healing Touch	Healing Touch Therapy	Healing Touch Therapy
Relaxation Therapy	Relaxation Therapy	Relaxation Therapy
Standard Care	Standard Care	Standard Care

Primary Outcome Measures

Name	Time	Method
natural killer cell cytotoxicity	Baseline to week 6
T-cell counts	Baseline to week 6
side effects	Baseline to week 6

Secondary Outcome Measures

Name	Time	Method
distress	Baseline to week 6
WBC and RBC	Baseline to week 6
days of treatment delay	Baseline to week 6
salivary cortisol	Baseline to post-treatment

Trial Locations

Locations (1)

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States