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The Cancer Disparities Research Partnership Program Experience in Southern Mississippi. Singing River Hospital System Pascagoula, Mississippi. CDRP Program Elements. Partnership among community hospital and academic institutions TeleSynergy Patient Navigation Community Outreach.
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Singing River Hospital System
W. Sam Dennis, PhD, MD
P.I., Singing River Hospital System
Sharon Spencer, MD
P.I., University of Alabama Comp. CA Center – Birmingham
Vince Herron, MD
P.I., University of Mississippi Medical center -- Jackson
CALGB 49907 – Breast Cancer Study
We would like to provide some very basic information about a clinical trial that your physician has begun to discuss with you. Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. The goal of this research is to find better ways to treat cancer and help cancer patients.
As one of your treatment choices, you are being asked to consider participating in this clinical trial because you are a woman 65 years of age or older with early stagebreastcancer that has been removed by surgery. We believe that you may meet the eligibility requirements for this study.
This trial is being conducted in many locations by the National Cancer Institute through a research group called CALGB. The Singing River Hospital System Regional Cancer Center is conducting the study locally. It is expected that about 600-1,800 people will join this study.
WHY IS THIS RESEARCH STUDY BEING DONE?
The purpose of this study is to compare the safety and effectiveness of adjuvant combination chemotherapy using either cyclophosphamide + methotrexate + 5-flurouracil (CMF), or doxorubicin (also called Adriamycin) + cyclophosphamide (AC), with the chemotherapy drug capecitabine, in women 65 years of age and older. The study will also help gain more information about the effects of each of the treatments on physical and emotional well-being and how well the participants assigned to receive capecitabine follow the treatment plan.
WHAT ARE THE TREATMENT POSSIBILITIES?
You will be “randomized” into one of the treatment groups described below. Randomization means that you are assigned to a group by chance. The treatment group you are assigned to is chosen by a computer. Neither you nor your doctor will choose which group you will be in. You will have an equal chance of being assigned to either group.
If you are assigned to this treatment group, you and your doctor will decide whether you will receive the CMF or the AC standard combination chemotherapy. These treatments are given as outpatient treatment in the clinic.
If you choose CMF, you will be given a prescription for cyclophosphamide tablets, which you will take by mouth, daily for 14 days. You will be given methotrexate and 5-fluorouracil, through a vein, on days 1 and 8. This treatment will be repeated every 28 days. This 28 day period is called a treatment cycle. You will receive 6 cycles of this treatment.
If you choose AC, you will be given doxorubicin and cyclophosphamide through a vein on day 1, every 21 days. This 21 day period is called a treatment cycle. You will receive 4 cycles of this treatment.
If you are assigned to this treatment group you will be given a supply of capecitabine tablets, which you will take at home, by mouth, twice daily for 14 days. This treatment will be repeated every 21 days. This 21 day period is called a treatment cycle. You will receive 6 cycles of this treatment. The study staff will give you additional instructions on how to take the capecitabine.
(con’td – next page)
CALGB 49907 – Breast Cancer Study
All Treatment Groups
After you have completed the study treatment, if your breast cancer is the type that is responsive to hormones your doctor may recommend hormonal therapy with tamoxifen, anastrozole, exemstane or lettozoloe.
WHAT TESTS ARE INVOLVED?
If you take part in this study, you will have the following routine tests and procedures before the study treatment begins: you will be asked to give your medical history and have a physical examination, blood tests, a chest x-ray and a mammogram. If you are going to receive the AC treatment, you will have a MUGA scan or an echocardiogram, which measure your heart’s ability to pump.
During the time that you are receiving the study treatment, a physical examination and blood tests will be done on day 1 of each treatment cycle. If you are receiving the CMF treatment blood tests will also be done on day 8 of each cycle. MUGA scans or echocardiograms will be done as your doctor feels necessary.
After the study treatment has been completed, the physical examinations will be done every 6 months for 2 years, then annually thereafter. The blood tests and mammograms will be done annually.
HOW LONG ARE PARTICIPANTS IN THE STUDY?
We think you will receive study treatment for 3 to 6 months, depending on which treatment group you are assigned to. After the treatment has been completed your doctor will follow your medical condition for up to 15 years to learn about the long-term effects of the study.
Your doctor will discuss your treatment options with you again, including the opportunity to participate in this study. If you are interested and you and your doctor agree that this study would be of potential benefit to you in treating your cancer, the Research Nurse will do further evaluation of your records to make sure you are fully eligible to join the study. If you qualify to join the study, you will be given as much time as needed to ask questions and make an informed decision. We have a research nurse available to help answer your questions.
WHERE CAN YOU GET MORE INFORMATION?
If you are interested in learning more about the opportunity to participate in this research study, please let your doctor know. You may call the Singing River Regional Cancer Center Research Nurse at 228-809-5639 or e-mail M_RECORE@srhshealth.com.
You can call the Cancer Information Service at 1-800-4-CANCER or visit the National Cancer Institute’s Cancer Trials Web Site at http://www.cancer.gov/clinicaltrials for information on clinical trials or http://www.cancer.gov/cancerinformation for information on cancer.
No Study Available: 166 cases
Study Available: 80
Not Eligible (stage; co-morb.) 33
MD Preference to tx off-study 12
Patient Declined 15 Insurance would not cover 12