Clinical trial NCT00519545: Prayer as a Possible Adjuvant Treatment for Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: breast
cancer
stage
one
four
Lead sponsor: Southwestern Regional Medical Center
Sponsor class: OTHER
Collaborators: name: Gateway for Cancer Research
First posted: 2007-08-22
Enrollment: 15
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: C. Evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America at Southwestern Regional medical Center
state: Oklahoma
Study officials:
affiliation: Cancer Treatment Centers of America
name: Stephen Ray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Treatment Centers of America at Southwestern Regional Medical Center
name: Petra Ketterl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Treatment Centers of America
name: Percy McCray, Rev.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Treatment Centers of America at Southwestern Regional Medical Center
name: Michael Langham, Rev.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Control Center of Charleston
name: Daniel Nixon, MD
role: PRINCIPAL_INVESTIGATOR
References: