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Prayer as a Possible Adjuvant Treatment for Breast Cancer

S

Southwestern Regional Medical Center

Status

Completed

Conditions

Breast Neoplasms

Treatments

Behavioral: Prayer

Study type

Interventional

Funder types

Other

Identifiers

NCT00519545
CTCA 05-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Female

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

15 participants in 2 patient groups

1
Experimental group
Description:
scripted prayer group (intervention group)
Treatment:
Behavioral: Prayer
2
No Intervention group
Description:
no prayer intervention group (non-intervention group)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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