Breast NeoplasmsNCT00519545
Prayer as a Possible Adjuvant Treatment for Breast Cancer
A study testing Prayer in people with Breast Neoplasms, run by Southwestern Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Prayer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Willing to comply with monthly follow-up phone calls.
- Willing to complete questionnaires at regular oncology clinic visits.
- Able to read write \& understand English.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Centers of America at Southwestern Regional medical Center
Tulsa, Oklahoma, 74133
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Prayer
- Keywords
- breast, cancer, stage, one, four
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrayerBehavioural
Data collection on physiological biomarkers
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | scripted prayer group (intervention group) Receives: Behavioral: Prayer |
| 2 | No intervention | no prayer intervention group (non-intervention group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A. Evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters approximately every three months at the subjects routine oncology visit.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startMar 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gateway for Cancer Research
- Investigators
- Stephen Ray, MD, Principal investigator, Cancer Treatment Centers of AmericaPetra Ketterl, MD, Principal investigator, Cancer Treatment Centers of America at Southwestern Regional Medical CenterPercy McCray, Rev., Principal investigator, Cancer Treatment Centers of AmericaMichael Langham, Rev., Principal investigator, Cancer Treatment Centers of America at Southwestern Regional Medical CenterDaniel Nixon, MD, Principal investigator, Cancer Control Center of Charleston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519545
- Sponsor's protocol ID
- CTCA 05-04
- Status last verified
- Jan 2012
- First submitted
- 20 Aug 2007
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00519545
- Acronym / sponsor ID
- CTCA 05-04
- Conditions
- Breast Neoplasms
- Keywords
- breast, cancer, stage, one, four
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Southwestern Regional Medical CenterUniversity, hospital or other
- Collaborators
- Gateway for Cancer Research
- Study start
- Mar 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Prayerscripted prayer group (intervention group) |
| 2 | No intervention | –no prayer intervention group (non-intervention group) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrayerData collection on physiological biomarkers | Behavioural | 1 |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Ray, MD principal investigator
Cancer Treatment Centers of America
Petra Ketterl, MD principal investigator
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Percy McCray, Rev. principal investigator
Cancer Treatment Centers of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prayer in people with Breast Neoplasms, run by Southwestern Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.