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Prayer as a Possible Adjuvant Treatment for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Gateway for Cancer Research
Information provided by:
Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT00519545
First received: August 20, 2007
Last updated: January 23, 2012
Last verified: January 2012
History of Changes

August 20, 2007
January 23, 2012
March 2006
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00519545 on ClinicalTrials.gov Archive Site
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Prayer as a Possible Adjuvant Treatment for Breast Cancer
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

The goal of this study is to help determine the biochemical mechanisms underlying previously demonstrated health benefits of prayer, and to track humoral changes in various prayer activities.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Breast Neoplasms
Behavioral: Prayer
Data collection on physiological biomarkers
  • Experimental: 1
    scripted prayer group (intervention group)
    Intervention: Behavioral: Prayer
  • No Intervention: 2
    no prayer intervention group (non-intervention group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Primary histological diagnosis of Stage I-IV breast cancer.
  2. Initial diagnosis of breast cancer within 5 year of study enrollment.
  3. Not currently receiving chemotherapy or radiation therapy. Hormone therapy is allowed.
  4. Life expectancy of at least 12 months.
  5. ECOG performance status of 0, 1, or 2.
  6. Willing to sign informed consent indicating that they are aware of the investigational nature of the study and the randomized study design.
  7. Willing to comply with monthly follow-up phone calls.
  8. Willing to complete questionnaires at regular oncology clinic visits.
  9. Able to read write & understand English.

Exclusion Criteria:

  1. Concurrent treatment with chemotherapy or radiation therapy
  2. Less than 3 months since last dose of chemotherapy or radiation therapy.
  3. Breast cancer diagnosis more than 5 years prior to study enrollment
  4. Less than 21 or greater than to 80 years old.
  5. Life threatening or severe concurrent non-malignant conditions.
  6. Uncontrolled diabetes mellitus.
  7. Severe heart disease.
  8. Severe liver disease. Severe lung disease.
  9. History of smoking within 5 years of study enrollment.
  10. Psychological or psychiatric disorder that would interfere with study compliance.
  11. History of missed appointments or poor medical compliance.
  12. Inability to understand instructions on how to complete a questionnaire.
  13. No access to a phone.
Female
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519545
CTCA 05-04
No
Dan Nixon, M.D., Cancer Control Center of Charleston, Charleston South Carolina
Southwestern Regional Medical Center
Gateway for Cancer Research
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
Southwestern Regional Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP