The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Muscle relaxation training
Healing Touch (HT) therapy
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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 6 weeks
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)
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Subjects in all groups will give 4 blood samples during the study
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks