Healing Touch and Relaxation Therapies in Cervical Cancer Patients

Study Overview
=================
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.

Official Title
-----------------
Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms

Conditions
-----------------
Cervix Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Healing Touch Therapy
* Behavioral: Relaxation Therapy
* Behavioral: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healing Touch<br>Healing Touch Therapy | Behavioral: Healing Touch Therapy<br> <br> |
| Active Comparator: Relaxation Therapy<br>Relaxation Therapy | Behavioral: Relaxation Therapy<br> <br> |
| Placebo Comparator: Standard Care<br>Standard Care | Behavioral: Standard Care<br>* Standard Care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| natural killer cell cytotoxicity |  | Baseline to week 6 | 
| T-cell counts |  | Baseline to week 6 | 
| side effects |  | Baseline to week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relaxation Techniques, Radiation, Drug Therapy, Healing Touch