Back to resultsPrayer as a Possible Adjuvant Treatment for Breast Cancer
Primary Purpose
Breast Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prayer
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Neoplasms focused on measuring breast, cancer, stage, one, four
Eligibility Criteria
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.
Sites / Locations
- Cancer Treatment Centers of America at Southwestern Regional medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
scripted prayer group (intervention group)
no prayer intervention group (non-intervention group)
Outcomes
Primary Outcome Measures
A. Evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters approximately every three months at the subjects routine oncology visit.
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.
C. Evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires.
Secondary Outcome Measures
Full Information
NCT ID
NCT00519545
First Posted
August 20, 2007
Last Updated
January 23, 2012
Sponsor
Southwestern Regional Medical Center
Collaborators
Gateway for Cancer Research
1. Study Identification
Unique Protocol Identification Number
NCT00519545
Brief Title
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
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Southwestern Regional Medical Center
Collaborators
Gateway for Cancer Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast, cancer, stage, one, four
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
scripted prayer group (intervention group)
Arm Title
2
Arm Type
No Intervention
Arm Description
no prayer intervention group (non-intervention group)
Intervention Type
Behavioral
Intervention Name(s)
Prayer
Intervention Description
Data collection on physiological biomarkers
Primary Outcome Measure Information:
Title
A. Evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters approximately every three months at the subjects routine oncology visit.
Time Frame
2 years
Title
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.
Time Frame
2 years
Title
C. Evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Ray, MD
Organizational Affiliation
Cancer Treatment Centers of America
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petra Ketterl, MD
Organizational Affiliation
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Percy McCray, Rev.
Organizational Affiliation
Cancer Treatment Centers of America
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Langham, Rev.
Organizational Affiliation
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Nixon, MD
Organizational Affiliation
Cancer Control Center of Charleston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Treatment Centers of America at Southwestern Regional medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
12. IPD Sharing Statement
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Prayer as a Possible Adjuvant Treatment for Breast Cancer
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