Cervical Cancer
Conditions
Keywords
cervical cancer, healing touch, healing touch therapy
Brief summary
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.
Detailed description
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.
Interventions
BEHAVIORALRelaxation training
Muscle relaxation training
BEHAVIORALTherapeutic touch
Healing Touch (HT) therapy
OTHERQuestionnaire administration
OTHERAncillary studies
Subjects in all groups will give 4 blood samples during the study
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients are randomized to relaxation, healing touch, or standard care arms of the study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in natural killer cell cytotoxicity (NKCC) | 6 weeks | 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. |
| Number of chemoradiation-related toxicities | 6 weeks | 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 |
| Number of days of treatment delay due to chemoradiation-related toxicities | 6 weeks | 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 |
| Change in participant reports of depression | 6 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in participant reports of fatigue | 6 weeks | 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. |
| Change in participant reports of anxiety | 6 weeks | 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) |
| Change in metabolomic measures | 6 weeks | 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. |
| Change in white blood cell counts | 6 weeks | 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. |
| Change in red blood cell counts | 6 weeks | 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. |
| Change in participant reports of quality of life | 6 weeks | 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). |
Outcome results
None listed