Prayer as a Possible Adjuvant Treatment for Breast Cancer

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519545
• Other study ID #: CTCA 05-04
• Status: Completed
• Phase: N/A
• First received: August 20, 2007
• Last updated: January 23, 2012
• Start date: March 2006
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Southwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Prayer
Data collection on physiological biomarkers

Locations

Country	Name	City	State
United States	Cancer Treatment Centers of America at Southwestern Regional medical Center	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Southwestern Regional Medical Center	Gateway for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A. Evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters approximately every three months at the subjects routine oncology visit.		2 years	No
Primary	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.		2 years	No
Primary	C. Evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires.		2 years	No

External Links

•   Click here for more information about this study.