U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Single Blind (Subject), Historical Control, Single Group Assignment, Efficacy Study
Official Title: Prayer as a Possible Adjuvant Treatment for Breast Cancer - A Randomized Partially Blinded Controlled Clinical Trial Evaluating the Effect of Prayer on Humoral and Biochemical Parameters in Stage I-IV Breast Cancer
Further study details as provided by Southwestern Regional Medical Center:
Primary Outcome Measures:
A. Evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters approximately every three months at the subjects routine oncology visit. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
B. Monitor changes in cancer- related biomarkers, and evaluate these changes in relation to the participants' prayer activities as recorded since the previous oncology visit. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
C. Evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: March 2006
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
scripted prayer group (intervention group) Behavioral: Prayer
Data collection on physiological biomarkers
2: No Intervention
no prayer intervention group (non-intervention group)
Detailed Description:
The purpose of this pilot study is to investigate certain biological mechanisms that may underlie the beneficial effects seen among cancer patients who pray. It will evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters, monitor changes in cancer related biomarkers and evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires.
Eligibility
Ages Eligible for Study: 21 Years to 80 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria Inclusion Criteria:
Primary histological diagnosis of Stage I-IV breast cancer.
Initial diagnosis of breast cancer within 5 year of study enrollment.
Not currently receiving chemotherapy or radiation therapy. Hormone therapy is allowed.
Life expectancy of at least 12 months.
ECOG performance status of 0, 1, or 2.
Willing to sign informed consent indicating that they are aware of the investigational nature of the study and the randomized study design.
Willing to comply with monthly follow-up phone calls.
Willing to complete questionnaires at regular oncology clinic visits.
Able to read write & understand English.
Exclusion Criteria:
Concurrent treatment with chemotherapy or radiation therapy
Less than 3 months since last dose of chemotherapy or radiation therapy.
Breast cancer diagnosis more than 5 years prior to study enrollment
Less than 21 or greater than to 80 years old.
Life threatening or severe concurrent non-malignant conditions.
Uncontrolled diabetes mellitus.
Severe heart disease.
Severe liver disease. Severe lung disease.
History of smoking within 5 years of study enrollment.
Psychological or psychiatric disorder that would interfere with study compliance.
History of missed appointments or poor medical compliance.
Inability to understand instructions on how to complete a questionnaire.
No access to a phone.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519545
Contacts
Contact: JJ Stark, BS 1-877-896-3698 jj.stark@ctca-hope.com
Contact: Carol Goetz, RN 1-877-896-3698 carol.goetz@ctca-hope.com
Locations
United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional medical Center Recruiting
Tulsa, Oklahoma, United States, 74133
Principal Investigator: Petra Ketterl, MD
Sponsors and Collaborators
Southwestern Regional Medical Center
Gateway for Cancer Research
Investigators
Principal Investigator: Stephen Ray, MD Cancer Treatment Centers of America
Principal Investigator: Petra Ketterl, MD Cancer Treatment Centers of America at Southwestern Regional Medical Center
Principal Investigator: Percy McCray, Rev. Cancer Treatment Centers of America
Principal Investigator: Michael Langham, Rev. Cancer Treatment Centers of America at Southwestern Regional Medical Center
Principal Investigator: Daniel Nixon, MD Cancer Control Center of Charleston
Responsible Party: Cancer Control Center of Charleston, Charleston South Carolina ( Dan Nixon, M.D. )
Study ID Numbers: CTCA 05-04
Study First Received: August 20, 2007
Last Updated: April 22, 2009
ClinicalTrials.gov Identifier: NCT00519545 History of Changes
Health Authority: United States: Institutional Review Board
Keywords provided by Southwestern Regional Medical Center:
breast
cancer
stage
one
four
Study placed in the following topic categories:
Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms
Breast Diseases
Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases
ClinicalTrials.gov processed this record on June 08, 2009
