Quality of Life Interventions During Cervical Cancer Treatment
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2001
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedMay 27, 2021
May 1, 2021
6.8 years
May 20, 2021
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
Change in participant reports of anxiety
6 weeks
Change in white blood cell counts
6 weeks
Change in red blood cell counts
6 weeks
Change in participant reports of quality of life
6 weeks
Change in participant reports of fatigue
6 weeks
- +1 more secondary outcomes
Study Arms (3)
Relaxation training following daily radiation
EXPERIMENTALAll 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
Healing touch therapy following daily radiation
EXPERIMENTALAll 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.
No intervention
ACTIVE COMPARATORThe 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.
Interventions
Muscle relaxation training
Healing Touch (HT) therapy
Subjects in all groups will give 4 blood samples during the study
Eligibility Criteria
You may qualify if:
- Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 20600809BACKGROUNDHart 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.
PMID: 21951738BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Lutgendorf, PhD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 27, 2021
Study Start
June 4, 2001
Primary Completion
March 15, 2008
Study Completion
July 1, 2014
Last Updated
May 27, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share