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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Behavioral: Prayer

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
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Cancer Treatment Centers of America at Southwestern Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Southwestern Regional Medical Center
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: August 20, 2007
• First Submitted That Met QC Criteria: August 20, 2007
• First Posted (Estimate): August 22, 2007

Study Record Updates

• Last Update Posted (Estimate): January 24, 2012
• Last Update Submitted That Met QC Criteria: January 23, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: cancer; breast; stage; one; four
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CTCA 05-04