Research at St. Francis

 

Research is essential if we are going to improve the healthcare of people today and generations to come.  Our healthcare team is working on cures, treatments to stop threatening illnesses, and ways to prevent diseases.

Clinical research is an important part of our hospital operations and brings superior patient care.  Our patients have an opportunity to access the newest approaches to medicine.  This is what distinguishes us from other community hospitals.

 Understanding Clinical Trials

There are strict scientific and ethical principles used in clinical trials. Researchers must follow the study’s protocol, which is the plan for conducting the trial. The Institutional Review Board (IRB) at St. Francis Medical Center must approve the protocol before the study can start. The board, which includes clergy, consumers and health professionals, ensures that the study will be conducted fairly and that the participants will not likely be harmed. The IRB also conducts ongoing review of the study. The chair of the IRB at St. Francis Medical Center is Dr. J. Michael Smith.

The study is thoroughly explained to potential patients through the Informed consent process. During this process, the researchers discuss the study’s purpose, tests, possible risks and benefits and other procedures and answer any questions that the patient’s may have. Participation in clinical trials is completely voluntary, and the patients always remain anonymous. The informed consent process continues throughout the study. Any new information that arises on benefits, risks, or side effects is given to the participants immediately. Participants are able to withdraw from the study at any time.

Phases of Clinical Trials

Clinical trials are conducted in four phases:

• Phase I studies test a new drug or treatment for the first time in people (20-80) to evaluate its safety, to determine a safe dosage range, and to identify side effects.
• Phase II studies focus on learning whether the new treatment can effect on the disease that the study drug is intended for. These studies involve 100-300 people.
• Phase III studies compare the results of people taking the new treatment with results of people taking the standard treatment.
  Participants are assigned by chance (randomized) into separate groups that compare the different treatments. Neither researchers nor participants can choose which groups they will be placed in. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, no one knows which treatment will be best. Phase III studies include 1000-3000 people.
• Phase IV studies collect more information on a drug or treatment after the FDA approves it, including the best way to use it and its risks and benefits.

 Cancer Protocols

Breast

S0221  A Phase III trial of continuous schedule AC + G vs every 2 week schedule AC, followed by paclitaxel given either every 2 weeks or weekly for 12weeks as post-operative adjuvant therapy in node + or high risk node negative breast cancer.
Principal Investigator: Dr. E. Rosvold

NSABP B-39 A Phase III Study of conventional whole breast irradiation (WBI)
versus partial breast irradiation (PBI) for women with stage 0,1, or II
breast cancer.
Principal Investigator: Dr. Jo Ann Chalal

CALGB 40302 Endocrine Therapy with or without inhibition of EGF and
HER2  growth factor receptors: A randomized double blind placebo
controlled Phase III trial of fulvestrant with or without lapatinib for
postmenopausal women with hormone receptor positive advanced breast cancer.
Principal Investigator: Dr. E. Rosvold

ACOSOG Z1031A A randomized phase III trial comparing 16 to 18 weeks
of neoadjuvant exemestane, letrozole or anastrozole in postmenopausal
women with clinical stage II and III ER + breast cancer.
Principal Investigator: Dr. E. Rosvold

NSABP-B-42 Clinical trial to determine the efficacy of 5 years of Letrozole
compared to placebo in patients completing five years of hormonal therapy
consisting of an armatase inhibitor (AI) or Tamoxifen followed by an AI
in prolonging disease-free survival in postmenopausal women with hormone
receptor positive breast cancer.
Principle Investigator: Dr. E. Rosvold

Gastro-Intestinal

E 5202 A Randomized Phase III Study comparing 5FU, Leucovorin andoxaliplatin vs 5FU, Leucovorin, oxaliplatin and bevacizumab in patients
with stage II colon cancer at high risk for recurrence to determine prospectively the prognostic value of molecular markers. 
Principal Investigator: Dr. E. Rosvold

N0147 A Randomized Phase III Trial of Oxaliplatin, plus 5FU/Leucovorin
with or without Cetuximab after curative resection for patients with
stage III colon cancer.
Principal Investigator: Dr. E. Rosvold

S0600 A Phase III Trial of Irinotecan based chemotherapy plus cetuximab
with or without bevacizumab as second-line therapy for patients
with metastatic colorectal cancer who have progressed on bevacizumab 
with either folfox,optimox or xelox.
Principal Investigator: Dr. E. Rosvold

FER GI-002 A Phase II Study of the combination of cetuximab, capecitabine,
and oxaliplatine with or without bevacizumab as initial therapy for metastatic
colorectal cancer.
Principal Investigator: Dr. E. Rosvold

Genitourinary

RTOG 0126 A Phase III Randomized Study of high dose 3D-CRT/IMRT versus standard dose 3D-CRT/IMRT in patients treated for localized prostate cancer
Principal Investigator: Dr. Jo Ann Chalal

Lung

E1505 A Phase III Study Randomized Trial of adjuvant chemotherapy
with or without bevacizumab for completely resected stage IB-IIIA NSCLC.
Principal Investigator: Dr. E. Rosvold

Prostate Cancer

S0421 Phase III study of Docetaxel and Atrasentan versus Docetaxel
placebo for patients with advanced hormone refractory prostate cancer.
Principle Investigator: Dr. E. Rosvold

 Cardiac

Clinical Evaluation of Remote Notification to Reduce Time to Clinical
Decision (CONNECT).
Principal Investigator: B. Sodowick, MD

Atlantic C-PORT trial
Principal Investigator: A. Wolfe, MD

 Current Studies Enrolling at St. Francis Medical Center

 

 

 Pulmonary Medicine

 

Nursing Research Studies

                 Phenomenological Study Trust in Minority Families
                     The Purpose of this study is to determine a pattern for trust
                     building between African-American prenatal parents and nurses.
                     They want to find out what are the facilitators and deterrents of
                     trust between nurses and African-American prenatal clients.

Principle Investigator: Roseanne Best-Dougherty, BS, RN
Co- Investigators: Jean Hodachok, MA, RN,  Margaret Nucero,RN, MSN, FNP,BC,  Pricilla O’Connor, PhD, APRN, BC.  

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Prevention of Aspiration Pneumonia in Patients with
Acute Ischemic Stroke:
The purpose of this study is to evaluate the effectiveness of a nursing assessment tool to eliminate aspiration pneumonia in patients with acute ischemic stroke and status.

Kathleen M. Messineo, BSN, RN,CCRN, Principle Investigator,
Co-Investigators: Marilyn Greenberg, MA, CCC-SLP, Margaret Nucero, MS, FNP, BC, Rebecca Raymond, RN, Colleen Rudnick, RN, Barbara M. Simonds, MSN, RN, CAN, Priscilla O’Connor, PhD, APRN, BC, Consultant.

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Introduction of Nutrition in Patients with Acute Ischemic Stroke:
The purpose of this study is to determine differences in time that oral nutrition is introduced to patients with acute ischemic
stroke prior to and after the introduction of a dysphagia screening form.

Kathleen M. Messineo, BSN, RN, CCRN, Principle Investigator,
Co-Investigators: Marilyn Greenberg, MA, CCC-SLP, Margaret Nucero, MS, FNP, BC, Rebecca Raymond, RN, Colleen Rudnick, RN, Barbara M. Simonds, MSN, RN, CAN, Priscilla O’Connor, PhD, APRN, BC, Consultant.

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The Influence of Concept Mapping on Critical Thinking: A Quasi-Experimental Study
Purpose: the purpose of this study is to determine if concept mapping influences critical thinking scores on standardized tests in student nurses who have completed a two-year hospital-based diploma program.

Primary Investigator: Margaret Nucero, MSN, CRNP
Co-Investigator: Priscilla O’Connor, PhD, APRN, BC

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Reduction of Injuries in Health Care Workers Proposal
The purpose of this study is to compare the number of injuries
prior and after the use of equipment and an educational
program.

Investigators:Dale Festa, RN, Margaret Nucero, MSN, CRNP, BC,
Priscilla O’Connor, PhD, APRN, BC

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The Effect of Rounding on Patient Satisfaction and Patient Falls
The purpose of this study is to determine the difference in patient
satisfaction scores and patient falls prior to and following the use
of nurse hourly rounding as an intervention.

Investigators:Margaret Nucero, MSN, CRNP, Carol McAloon, MSN, RN, Tina Snyder, BSN, RN, Priscilla O’Connor, PhD, APRN, BC.

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Nurse Empowerment: A Participatory Approach for Licensed Practical Nurses to Develop Their Own Empowerment Program.
The purpose of this study is to define the nurses’ perception of empowerment as well as to clarify the current actions nurses’ use and perception of influence on their professional environment and through a participatory approach of nurses’, to develop an empowerment program that pertains to a magnet hospital environment.

Primary Investigator: Matthew P. Guarno, RN, BSN,
Co-Investigators: Margaret Nucero, RN, MSN, FNP, BC
Pricilla O’Connor,RN,PhD, Connie Wilson, LPN

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Identification of Patients at Risk for Deep Vein Thrombosis
The purpose of this study is to compare the incidence of secondary deep vein thrombosis (DVT) in a group of patients prior to and after the use of a risk assessment tool.

Primary Investigators: Patricia Smith BSN, RN, Francisco Villota, MD
Co-Investigators: Margaret Nucero, MSN, APRN, FNP, BC, Priscilla O’Connor,PhD, RN

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Nursing Research Day
June 12, 2008
11:00am - 3:00pm
SFMC Cafeteria 

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