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Prayer as a Possible Adjuvant Treatment for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00519545
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : January 24, 2012
Sponsor:
Collaborator:
Gateway for Cancer Research
Information provided by:
Southwestern Regional Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Prayer Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Study Start Date : March 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
scripted prayer group (intervention group)
Behavioral: Prayer
Data collection on physiological biomarkers
No Intervention: 2
no prayer intervention group (non-intervention group)



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519545


Locations
United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional medical Center
Tulsa, Oklahoma, United States, 74133
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: Dan Nixon, M.D., Cancer Control Center of Charleston, Charleston South Carolina
ClinicalTrials.gov Identifier: NCT00519545     History of Changes
Other Study ID Numbers: CTCA 05-04
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

Keywords provided by Southwestern Regional Medical Center:
breast
cancer
stage
one
four

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases