Prayer as a Possible Adjuvant Treatment for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: Prayer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary histological diagnosis of Stage I-IV breast cancer. Initial diagnosis of breast cancer within 5 year of study enrollment. Not currently receiving chemotherapy or radiation therapy. Hormone therapy is allowed. Life expectancy of at least 12 months. ECOG performance status of 0, 1, or 2. Willing to sign informed consent indicating that they are aware of the investigational nature of the study and the randomized study design. Willing to comply with monthly follow-up phone calls. Willing to complete questionnaires at regular oncology clinic visits. Able to read write & understand English. Exclusion Criteria: Concurrent treatment with chemotherapy or radiation therapy Less than 3 months since last dose of chemotherapy or radiation therapy. Breast cancer diagnosis more than 5 years prior to study enrollment Less than 21 or greater than to 80 years old. Life threatening or severe concurrent non-malignant conditions. Uncontrolled diabetes mellitus. Severe heart disease. Severe liver disease. Severe lung disease. History of smoking within 5 years of study enrollment. Psychological or psychiatric disorder that would interfere with study compliance. History of missed appointments or poor medical compliance. Inability to understand instructions on how to complete a questionnaire. No access to a phone.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>scripted prayer group (intervention group) | Behavioral: Prayer<br>* Data collection on physiological biomarkers<br>|
| No Intervention: 2<br>no prayer intervention group (non-intervention group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, breast, stage, one, four