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
  Purpose

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 Intervention
Breast Neoplasms
Behavioral: Prayer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


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 ]

Enrollment: 15
Study Start Date: March 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
scripted prayer group (intervention group)
Behavioral: Prayer
Data collection on physiological biomarkers
No Intervention: 2
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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: August 20, 2007
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014