NCT00519545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

Enrollment Period

5.8 years

First QC Date

August 20, 2007

Last Update Submit

January 23, 2012

Conditions

Breast Neoplasms

Keywords

breastcancerstageonefour

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

scripted prayer group (intervention group)

Behavioral: Prayer

2

NO INTERVENTION

no prayer intervention group (non-intervention group)

Interventions

PrayerBEHAVIORAL

Data collection on physiological biomarkers

1

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Treatment Centers of America at Southwestern Regional medical Center

Tulsa, Oklahoma, 74133, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Faith Healing

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Stephen Ray, MD

    Cancer Treatment Centers of America

    PRINCIPAL INVESTIGATOR

  • Petra Ketterl, MD

    Cancer Treatment Centers of America at Southwestern Regional Medical Center

    PRINCIPAL INVESTIGATOR

  • Percy McCray, Rev.

    Cancer Treatment Centers of America

    PRINCIPAL INVESTIGATOR

  • Michael Langham, Rev.

    Cancer Treatment Centers of America at Southwestern Regional Medical Center

    PRINCIPAL INVESTIGATOR

  • Daniel Nixon, MD

    Cancer Control Center of Charleston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

March 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations

US(1)