A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer Save

Date Added
August 20th, 2017
PRO Number
Pro00066211
Researcher
Katherine Sterba
Keywords
Cancer/Head & Neck, Nutrition
Summary

This research will develop and test a nutrition-focused mobile-support program for head and neck cancer patients and their caregivers at the end of treatment.

Phase I: To guide system development, we will conduct interviews with 15 individuals with head and neck cancer and their caregivers to understand the nutritional challenges faced at the end of treatment. We will also recruit 35 oncology dietitians to complete online surveys to identify key caregiver nutritional support tasks and caregiver demands.
Phase II: After system development, we will recruit 33 head and neck cancer patients and their main supporters to pretest our nutrition support system. Participants will be asked to complete two surveys and a one-time clinic session. The clinic session will include information and resources about symptoms and concerns and after the visit, the program will provide follow-up resources and support online for one month. Lastly, we we will conduct individual/small group interviews with 10 head and neck health care providers to evaluate feasibility and recommendations for future system development.

The information from this study may help us to improve supportive care programs in the future to help others as they complete head and neck cancer treatment.

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

Pembrolizumab In Combination With Anti-platelet Therapy For Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck Save

Date Added
August 15th, 2017
PRO Number
Pro00069442
Researcher
Carolyn Britten
Keywords
Cancer/Head & Neck
Summary

This is a study that looks at the use of anti-platelet therapy and chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC). Anti-platelet therapy is the use of drugs that reduce the blood?s ability to form clots. The overall goal of this study is to see if this therapy combination can increase the body?s ability to fight the disease.

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

A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Save

Date Added
June 13th, 2017
PRO Number
Pro00064826
Researcher
Terrence Day
Keywords
Cancer/Head & Neck, Drug Studies
Summary

This is a phase 1b/2, open-label, multicenter trial designed to look at the safety and efficacy of a study drug called SD 101 when injected into a tumor and used in combination with intravenous (IV) pembrolizumab in subjects with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The Medical University of South Carolina will only participate in phase 2 of this study and will include up to 10 subjects. Participation in this study will include up to 40 visits to the research center over approximately 110 weeks.

Institution
MUSC
Recruitment Contact
Lauren Card
843-792-5935
cardl@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

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
Courtney Marsh
843-792-0719
marshch@musc.edu

Phase II Trial of Nivolumab, a Anti-PD-1 Monoclonal Antibody, As a Novel Neoadjuvant Pre-surgical Therapy for Locally Advanced Oral Cavity Cancer Save

Date Added
January 24th, 2017
PRO Number
Pro00062193
Researcher
David Neskey
Keywords
Cancer/Head & Neck
Summary

This is for adults diagnosed with locally advanced oral cavity cancer.The purpose of this study is to look at the effectiveness of nivolumab in patients with oral cavity cancer that is amendable to surgery. Patients will have screening tests to determine eligibility. If eligible, subjects will have three to four doses of nivolumab prior to undergoing surgery. After surgery, subjects will enter a follow up period.

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

Phase II Investigation of Adjuvant Combined Cisplatin and Radiation with Pembrolizumab in Resected HNSCC Save

Date Added
October 25th, 2016
PRO Number
Pro00053781
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for participants who have been diagnosed with head and neck cancer that requires surgery as well as post-operative radiation and possibly cisplatin. The investigational drug in this study is Pembrolizumab. Pembrolizumab is a medication that is currently being tested in multiple cancers. It works by turning on your immune system to recognize and fight your cancer. The purpose of this study is to test the safety and the benefit of adding pembrolizumab to treatment that participants will already be getting for their cancer. Participants can be expected to be in this study for up to 3 years.

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

Phase 2, Multi-center, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients with Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy Save

Date Added
September 22nd, 2015
PRO Number
Pro00046620
Researcher
Anand Sharma
Keywords
Cancer, Cancer/Head & Neck, Drug Studies
Summary

This study is for subjects who have been diagnosed with head and neck cancer and are being treated with radiation therapy and chemotherapy. This treatment is expected to irritate the mouth and throat and cause a condition called oral mucositis, which may cause pain and difficulty swallowing. The investigational drug in this study is an oral rinse called BRILACIDIN. It is being studied to see if it can prevent or decrease the occurrence of oral mucositis. The purpose of this study is to see if BRILACIDIN can prevent or decrease the occurrence of oral mucositis. Participants can expect to be in this study for 14-15 weeks.

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

RNA Biomarkers in the Progression of Oropharyngeal Squamous Cell Carcinoma: A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina Save

Date Added
January 6th, 2015
PRO Number
Pro00033992
Researcher
Terrence Day
Keywords
Cancer, Cancer/Head & Neck
Summary

This study seeks to assess the evolving biomarkers identifiied in head and neck cancers including smoking related and human papillomavirus related markers and their correlation with clinical outcomes, quality of life, survivorship and cancer control.

Head and neck cancer patients will be offered the opportunity to participate in HeadNOG which includes survey information about cancer diagnosis, signs and symptoms, demographics, cancer site, stage and histology and long term outcomes.

This analysis will then assess RNA/DNA biomarkers and lipid profiles, and their role in the etiopathogenesis, treatment and outcomes for head and neck cancer.

It is the goal of HeadNOG to provide a date resource that results in strategies for personalized care of head and neck cancer patients in South Carolina for the future.

Ultimately, it is hoped that biomarkers will direct patient care and improve quality of life and cancer control.

Institution
MUSC
Recruitment Contact
Terrence Day
843=792-0719
dayt@musc.edu

Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer Save

Date Added
July 1st, 2014
PRO Number
Pro00033852
Researcher
Terrence Day
Keywords
Cancer, Cancer/Head & Neck, Surgery
Summary

This study is for adult male and female patients with a virus associated with head and neck cancer. The purpose of this study is to study the effects, good and/or bad of performing surgery through your mouth (what is referred to as transoral surgery) followed by treatment that is selected based on studying your cancer under a microscope by a doctor (called a pathologist), on you and your human papillomavirus associated oropharynx cancer. The study is being done because we think that the results of studying your cancer under the microscope can help us be more careful about how much extra treatment needs to be given after surgery.

Institution
MUSC
Recruitment Contact
Kristina Godwin
843-792-6349
woodrufk@musc.edu

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