Quality of Life Interventions During Cervical Cancer Treatment

Study Overview
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Brief Summary
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The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Detailed Description
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Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Official Title
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Quality of Life Interventions During Cervical Cancer Treatment

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Relaxation training
* Behavioral: Therapeutic touch
* Other: Questionnaire administration
* Other: Ancillary studies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy. Exclusion Criteria: Greater than Stage IVa cervical cancer Metastatic or recurrent cervical cancer Patients receiving only chemotherapy or only radiation therapy History of cancer of any site History of a transplant Diagnosed with any immunosupressive disorder (HIV, AIDS).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to relaxation, healing touch, or standard care arms of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relaxation training following daily radiation<br>All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery | Behavioral: Relaxation training<br>* Muscle relaxation training<br>* Other names: Relaxation;Other: Questionnaire administration<br> <br> Other: Ancillary studies<br>* Subjects in all groups will give 4 blood samples during the study<br>* Other names: Blood draw;|
| Experimental: Healing touch therapy following daily radiation<br>All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body. | Behavioral: Therapeutic touch<br>* Healing Touch (HT) therapy<br>* Other names: Healing touch;Other: Questionnaire administration<br> <br> Other: Ancillary studies<br>* Subjects in all groups will give 4 blood samples during the study<br>* Other names: Blood draw;|
| Active Comparator: No intervention<br>The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals. | Other: Questionnaire administration<br> <br> Other: Ancillary studies<br>* Subjects in all groups will give 4 blood samples during the study<br>* Other names: Blood draw;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in natural killer cell cytotoxicity (NKCC) | Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay. | 6 weeks | 
| Number of chemoradiation-related toxicities | Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0 | 6 weeks | 
| Number of days of treatment delay due to chemoradiation-related toxicities | Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care | 6 weeks | 
| Change in participant reports of depression | Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participant reports of anxiety | Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28) | 6 weeks | 
| Change in white blood cell counts | Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. | 6 weeks | 
| Change in red blood cell counts | Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. | 6 weeks | 
| Change in participant reports of quality of life | Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT). Higher scores indicate better quality of life. Range= (0-136). | 6 weeks | 
| Change in participant reports of fatigue | Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI). Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration. | 6 weeks | 
| Change in metabolomic measures | Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care. Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc. For any specific metabolite, higher levels indicates greater presence of the metabolite. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, healing touch, healing touch therapy