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Completed

NCT Number: NCT00519545

Prayer as a Possible Adjuvant Treatment for Breast Cancer

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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Key information

Age range

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Treatment Centers of America at Southwestern Regional medical Center

Tulsa, Oklahoma, 74133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prayer

Behavioral

Data collection on physiological biomarkers

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Southwestern Regional Medical Center

Other

Collaborators

  • Gateway for Cancer Research

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Aug 22, 2007
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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