Prayer as a Possible Adjuvant Treatment for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-01-31

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.

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

scripted prayer group (intervention group)

Group Type EXPERIMENTAL

Prayer

Intervention Type BEHAVIORAL

Data collection on physiological biomarkers

2

no prayer intervention group (non-intervention group)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prayer

Data collection on physiological biomarkers

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No