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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


N/A
21 Years
80 Years
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Stephen Ray, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Treatment Centers of America

Authority:

United States: Institutional Review Board

Study ID:

CTCA 05-04

NCT ID:

NCT00519545

Start Date:

March 2006

Completion Date:

January 2012

Related Keywords:

  • Breast Neoplasms
  • breast
  • cancer
  • stage
  • one
  • four
  • Breast Neoplasms
  • Neoplasms

Name

Location

Cancer Treatment Centers of America at Southwestern Regional Medical CenterTulsa, Oklahoma  74133-4564