Quality of Life Interventions During Cervical Cancer Treatment

Cervical Cancer Clinical Trial

Official title:

Quality of Life Interventions During Cervical Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905576
• Other study ID #: 200105058
• Status: Completed
• Phase: N/A
• Start date: June 4, 2001
• Est. completion date: July 2014

Study information

• Verified date: May 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: March 15, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Relaxation training
Muscle relaxation training
• Therapeutic touch
Healing Touch (HT) therapy

Other:
• Questionnaire administration

• Ancillary studies
Subjects in all groups will give 4 blood samples during the study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

References & Publications (2)

Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525. — View Citation

Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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