Ms. Leslie
Capo
Louisiana State University Health Sciences Center - NO
433 Bolivar St.
New Orleans, LA 70112
Phone: 504-568-4806
Fax:
E-mail: lcapo@lsuhsc.edu
Number of Human Subjects projects reported: 1
| LSUHSC-03-ER63615 | "Cancer Early Detection and Prevention Activities for the Stanley S. Scott Cancer Center, New Orleans, Louisiana" |
"Cancer Early Detection and Prevention Activities for the Stanley S. Scott Cancer Center, New Orleans, Louisiana"
Principal Investigator: Dr. Oliver Sartor, Louisiana State University Health Sciences Center
Project started in: 2003
This project ended in fiscal year 2006.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Louisiana State University Health Sciences Center - New Orleans
Most recent approval: 05/10/05
IRB approval number: 3588
Explanation of IRB approval:
Hurricane Katrina hit on 08/29/2006. The program associated with this study was immediately disbanded and all activity ceased. Therefore, no renewal of IRB approval was requested or given.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 09/01/05 to 08/31/06
Explanation:
These are the dates of the project's annual beginning and ending, rather than fiscal year dates.
Type(s) of Human Subjects Involvement:
Objectives and Methodology:
Partners in Health (PIH) is a community health education intervention, designed to increase the participation of medically underserved women, (particularly African-American women, 40 years and older, of low socioeconomic status and those with limited access to information and services) and at-risk women in breast and cervical health programs. Specific objectives of the program are to change knowledge, facilitate access to preventive health services, and improve compliance with recommended breast and cervical cancer screening and early detection practices among the target population. PIH utilizes community lay health educators from the community to act as community educators and health system "navigators." Services, including physical exams and mammograms, are provided free to the participant.
Risks to Subjects:
Human Subjects Involvement and Characteristics:
Subjects will be African-American, Hispanic, and Caucasian-American females 40 years of age and older. The subjects will be recruited by the Community Lay Health Educators at various community educational presentations, as well as through word of mouth.
Consenting Process:
The Community Lay Health Educators go through the consent form for the Partners in Health Program and explain each component to the participant prior to obtaining a signature.
Sources of Materials:
Participants will be asked to complete pre-tests and post-tests which evaluate their knowledge of breast cancer before and after participating in an educational presentation.
Potential Risks:
Potential risks to the subject undergoing mammography include a negligible amount of radiation exposure and discomfort during breast compression. There are no physical risks relative to the completion of the pre- and post-tests.
Adequacy of Protection Against Risks:
We believe that the combination of existing scientific controls, procedures, and methods, when combined with the work of the professional staff of LSUHSC, provides adequate protection against risks to human subjects. We have approval from LSUHSC's Institutional Review Board, which also ensures protection against risks to human subjects.
Potential Benefits of the Proposed Research to Subjects and Others:
Potential benefits to the participant include early detection of potentially deadly malignancies, as well as enhanced knowledge of cancer screening and a sense of empowerment over one's health status.
Importance of the Knowledge to be Gained:
Sadly, statistics indicate that cancer in Louisiana is frequently diagnosed at advanced and incurable stages. Approximately 180 Louisiana citizens die each week from cancer. Moreover, there is a disproportionate cancer death rate in African-American women, who experience a 1.4 times greater death rate due to breast cancer when compared to women of other races. In addition, African-American women present with their disease are at a more advanced stage. Hispanic women have the second highest rate of mortality (12.6 per 100,000) among minority populations.
Breast cancer is the most common cancer among women living in the New Orleans area and the second leading cause of cancer death among New Orleans women. We estimate that achieving a 10 percent reduction in the cancer death rate by using current early detection methods and current treatments could result in savings of $190,000,000 in medical costs over the next decade in the State of Louisiana.
Additionally, this may lead to the diagnosis of breast cancer in the early stages of disease and trends for a reduction in breast cancer mortality and the elimination of the gap in breast cancer mortality between African-American/Hispanic women and Caucasian-American women.
Inclusion of Women:
Women will be exclusively targeted for participation in the study.
Inclusion of Minorities:
By its very nature, this study will draw extensively from the predominantly African-American, Hispanic, and socioeconomically disadvantaged populations throughout the state.
Inclusion of Children:
Children will not be included in this study.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Louisiana State University Health Sciences Center - New Orleans
Most recent approval: 04/20/05
IRB approval number: 5927
Explanation of IRB approval:
Hurricane Katrina hit on 08/29/05. Immediately thereafter, this program was disbanded and all activity ceased. Therefore, no new IRB approval was sought or approved.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 07/01/05 to 07/31/06
Explanation:
These are the project's annual start and end dates, rather than fiscal year dates.
Type(s) of Human Subjects Involvement:
Objective:
The Louisiana Educational Early Detection (LEED) Program's primary purpose is to provide culturally sensitive community outreach and education to increase participation of traditionally underserved and at-risk men in prostate health programs. The LEED Program attempts to address the alarmingly high rate of cancer mortality in Louisiana, particularly among low-income minority groups.
Risks to the Subjects:
Human Subjects Involvement and Characteristics:
Subjects will be African-American and Caucasian-American males 40 years of age and older. The subjects will be recruited by the Principal Investigator (PI) from the Health Care Services Division hospitals and from the metropolitan New Orleans area.
Consenting Process:
Either the research nurse, project coordinators, or the principal investigator discusses the LEED research program with the potential participant and goes through the consent form item by item. Questions are answered and a signature is obtained, which is witnessed by whoever is obtaining consent.
Sources of Materials:
Participants will be asked to complete the Barriers, Knowledge, Attitudes and Behavior Survey. The surveys will either be completed at home and mailed in or via a telephone interview for those participants who fail to return the survey in a timely manner.
Potential Risks:
Potential risks to the subject undergoing prostate specific antigen (PSA) testing may include pain at the needle insertion site, fainting, bleeding, bruising, infection at the site, and, rarely, nerve damage. There are no physical risks relative to the completion of the survey.
Adequacy of Protection Against Risks:
We believe that the combination of existing scientific controls, procedures, and methods, when combined with the work of the professional staff of LSUHSC, provides adequate protection against risks to human subjects. We have approval from LSUHSC's Institutional Review Board, which also ensures protection against risks to human subjects.
Potential Benefits of the Proposed Research to Subjects and Others:
No direct benefit can be guaranteed to the study participant. The risk of hematoma formation is small.
Importance of the Knowledge to Be Gained:
Prostate cancer is the most common non-skin cancer diagnosed in men and the second leading cause of cancer deaths in men. The incidence of prostate cancer in African-American men is significantly higher than in other ethnic counterparts, and there is often significant loco-regional or metastatic disease present at the time of diagnosis. The proposed research is expected to provide support to the Health Disparity Elimination Model for prostate cancer. As such the research may uncover barriers to participating in health preventive habits for minority and socioeconomically disadvantaged men in Louisiana, as well as identify effective educational strategies or clues to participation in prostate cancer screening. Additionally, this may lead to the diagnosis of prostate cancer in the early stages of disease, and trends for a reduction in prostate cancer mortality and the elimination of the gap in prostate cancer mortality between African-American and Caucasian-American men.
Inclusion of Women:
Women will not be targeted for participation in the study.
Inclusion of Minorities:
By its very nature, this study will draw extensively from the predominantly African-American and socioeconomically disadvantaged populations throughout the state.
Inclusion of Children:
Children will not be included in this study.