Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan
Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@musc.edu

A multicenter, multinational, randomized, double-blind, pharmacokinetic and pharmacodynamic (PK/PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Save

Date Added
July 25th, 2017
PRO Number
Pro00067181
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with cancer and are receiving chemotherapy. The investigational drugs in this study are netupitant and palonosetron. The purpose of this study is to learn more about how well the combination of oral netupitant and oral palonosetron works in preventing nausea and vomiting associated with chemotherapy in children. Participation in the study will last for a maximum of 31 days, which includes a screening period up to 14 days before randomization (up to 7 days for patients aged less than 2 years), the day of enrollment/randomization, administration of study drugs and chemotherapy (Study Day 1), and the control visits (Study Days 2 to 5).

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III NSCLC Save

Date Added
July 18th, 2017
PRO Number
Pro00065494
Researcher
Joanna Metzner-sadurski
Keywords
Cancer, Cancer/Lung
Summary

This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.

Patients will be randomized to 1 of 4 treatment arms. After completion of study treatment, patients are followed up at 1 and 2 months, 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer Save

Date Added
June 27th, 2017
PRO Number
Pro00065422
Researcher
John Wrangle
Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with extensive-stage small cell lung cancer (SCLC). This study is being conducted to test whether or not rovalpituzumab tesirine (SC16LD6.5) combined with nivolumab alone or with nivolumab and ipilimumab are useful treatments for small cell lung cancer, after at least one prior treatment has failed.The investigational drugs in this study are Rovalpituzumab Tesirine (SC16LD6.5), Nivolumab (BMS-936558, MDX1106, ONO-4538, Opdivo®), and Ipilimumab (MDX-010, Yervoy®) . If participants agree to take part in this study, their involvement will last for as long as their study doctor confirms their cancer is not getting worse and there have been no significant side effects. There is no limit to the number of cycles of study treatment participants can receive.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer, ONC-LN-04 Save

Date Added
June 5th, 2017
PRO Number
Pro00061266
Researcher
Gerard Silvestri
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The primary objective of this study is to develop a blood-based gene expression signature, known as the ONC-LN-04 Lung Test, to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected. We intend to enroll volunteers who are being evaluated by a Medical University of South Carolina (MUSC) pulmonologist as part of their standard medical care. Participants will be current or former smokers, who have either (a) radiologic evidence of lung nodules, or (b) a confirmed diagnosis of non-small cell lung cancer (NSCLC) and has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy. A single blood sample will be obtained from willing participants, then stored and analyzed for measurement of gene expression and development of the ONC-LN-04 test. Active participation in this study will be over once a blood sample is obtained; however, we may need access to participants' medical records post-enrollment and sample collection in order to monitor medical outcomes. Review of participants' medical records will occur until up to approximately 2,500 subjects have been enrolled and have provided clinical information and a blood sample.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program Save

Date Added
May 1st, 2017
PRO Number
Pro00064511
Researcher
Gerard Silvestri
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to better understand the biomarkers of patients who are candidates for lung cancer screening. Biomarkers are biologic substances found in the blood and may be related to lung disease risk and detection. We intend to enroll volunteers who are participating in a lung cancer screening program at the Medical University of South Carolina and are being seen by a pulmonologist as part of their standard medical care. A single blood sample will be obtained, then stored and analyzed to better understand the biomarkers found in blood and to help develop and test blood based screening or diagnostic tests. Active participation in this study will be over once a blood sample is obtained. However, we may conduct medical chart reviews of some participants for up to 27 months in order to look at their medical outcomes.

Institution
MUSC
Recruitment Contact
Lindsey Owens
(843) 792-8233
owensli@musc.edu

AN OPEN-LABEL PHASE 2 STUDY OF DENINTUZUMAB MAFODOTIN (SGN-CD19A) IN COMBINATION WITH RCHOP (RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE) OR RCHP (RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE) COMPARED WITH RCHOP ALONE AS FRONTLINE THERAPY IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) OR FOLLICULAR LYMPHOMA (FL) GRADE 3B Save

Date Added
April 11th, 2017
PRO Number
Pro00064390
Researcher
Valeriy Sedov
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma that has never been treated. The investigational drug in this study is denintuzumab mafodotin. The purpose of this study is to find out what the side effects are and whether it is more or less effective when it is given together with other drugs that are a standard approved treatment for use in patients with lymphoma (DLBCL or FL3B). Participants can expect to be in the study for 4 years or until the study is closed or until they stop taking part.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Prospective Cohort Study of Body Image Disturbance in Patients with Surgically-Managed Head and Neck Cancer Save

Date Added
March 29th, 2017
PRO Number
Pro00065006
Researcher
Evan Graboyes
Keywords
Cancer, Cancer/Head & Neck
Summary

Arising in cosmetically and functionally critical areas, head and neck cancer (HNC) and its treatment cause commonly causes life-altering changes in appearance, swallowing, and speaking with resultant functional and social impairment and decreased quality of life. Concern about body image is a common problem with negative consequences in patients with HNC. Despite its importance, there is little data about body image disturbance in patients with HNC.

The objective of this study is to examine the how body image concerns in patients with head and neck cancer change over time and to identify which patients are at risk for developing concerns about body image. This study will provide preliminary data to inform future studies with the long-term goal of improving patient care by preventing and treating concerns about body image in patients with head and neck cancer.

Institution
MUSC
Recruitment Contact
Megan Scallion
843-876-2438
scallion@musc.edu

Prospective Study of the Relationship Between Patient Functional and Survival Priorities and Patient-Reported Outcomes of Function and Quality of Life in Patients with Head and Neck Cancer Save

Date Added
March 29th, 2017
PRO Number
Pro00063014
Researcher
Evan Graboyes
Keywords
Cancer, Cancer/Head & Neck
Summary

Patient-centered oncology care guided by patient-reported outcomes (PROs) is highly prioritized by the American Cancer Society and the National Cancer Institute. Routine use of PROs in cancer care is associated with improved processes of care, patient outcomes (including overall survival), and shared decision making. Shared decision making is critical for patients with HNSCC, because HNSCC occurs in cosmetically and functionally critical areas. Thus, patients with HNSCC are often forced to prioritize amongst potential treatment-related morbidities and functional outcomes related to appearance, swallowing, and speaking. Understanding how HNSCC patients prioritize functional outcomes in relation to one another would facilitate patient-centered head and neck oncology care. Unfortunately, there is a paucity of data on this topic. To date, there is minimal data about the temporal stability of patient priorities and it remains unknown how patient priorities relate to patient function or health-related quality of life (HRQOL) over time. These gaps in understanding prevent the delivery of optimal patient-centered cancer care that matches patient needs over time. This study will address how patients prioritize functional outcomes in relation to one another and what factors underpin those priorities.

The long-term goal of the research is to develop comprehensive patient-centered strategies for HNSCC patients based on knowledge of functional domain prioritization so that counseling, treatment, and supportive care can be patient-centered. The overall objective of this proposal is to use PRO measures to provide preliminary data examining how patient priorities relate to function and HRQOL over time. The central hypothesis is that patient functional priorities change over time such that patients more highly prioritize the functional domains in which they have decrements in function and de-prioritize the functional domains in which they maintain high function. Confirmation of this hypothesis will promote the development of patient-centric interventions at different points along the treatment spectrum to improve patient care. Our hypothesis will be tested by completing the following Specific Aims:

Specific Aim 1: To characterize how patient functional priorities change over time. Prior work has characterized functional priorities for patients with HNSCC in a cross-sectional manner. However, it remains unknown whether patient priorities change over time. In this study, patients will rate their functional outcome priorities using the Chicago Priority Scale before, during, and up to 9 months after treatment. Characterizing temporal changes in functional priorities will address this knowledge gap.

Specific Aim 2: To use PRO measures to examine the relationship between patient functional priorities and patient function and HRQOL over time. Prior work has addressed the relationship between patient priorities and function in a cross-sectional fashion, but it is unknown whether changes in function over time affect changes in priorities over time. In this study, reliable, validated PRO measures of swallowing, voice, body image, and HRQOL will be used to assess function and HRQOL before, during, and up to 9 months post-treatment. Longitudinal data about patient priorities, function, and HRQOL will be analyzed to examine how patient priorities relate to changes in function and HRQOL over time. Examining the relationship between patient priorities and function and HRQOL over time will address this critical knowledge gap.

Successful completion of these aims will yield the following expected outcomes. For Aim 1, it is expected that patient priorities will change over time and head and neck specific priorities will be less highly prioritized prior to treatment and more highly prioritized after treatment. For Aim 2, it is expected that patients will more highly prioritize the areas in which they have decrements in function over time and de-prioritize the areas in which they maintain high function. This pilot study will provide preliminary data to inform future studies with the long-term goal of improving patient care by 1) facilitating pre-treatment counseling via provision of information about expected prioritized functional outcomes, 2) guiding treatment decision-making to focus on treatment paradigms that minimize morbidity in a patient-centric way, and 3) directing provision of patient-centered supportive care resources for the right need for the right patient at the right time.

Future directions following this pilot study include: 1) scaling up the pilot study into an appropriately powered multi-site study, 2) extending into the survivorship period to assess the long-term relationship between priorities and function over time, and 3) synthesizing patient priority and patient function data to create patient-centric PRO performance measures.

Institution
MUSC
Recruitment Contact
Megan Scallion
843-876-2438
scallion@musc.edu

Can Diet and Physical Activity Modulate Ovarian Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival? Save

Date Added
March 16th, 2017
PRO Number
Pro00064952
Researcher
Carlton Schwab
Keywords
Cancer, Cancer/Gynecological, Exercise
Summary

The purpose of this study is to find out if a change in diet and exercise in women with ovarian, fallopian tube, and primary peritoneal of cancer has an effect on the length of time you are cancer free following your initial treatment.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

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