Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Recurrence

Head and Neck Neoplasms

Quality of Life

Patients will receive one EMA (Ecologic Momentary Assessment) per day for approximately 75 days, through the provided smart phone application.

EMA enables measurement of phenomena in real-time, natural settings.

EMA data will be used to identify moments of high distress, assess cancer treatment side effects, and assess barriers to care.

The EMA methodology used in this study will ask about current emotional, physical, behavioral, and social states.

The EMAs will consist of time-based sampling (i.e. a daily dairy), which will be prompted and initiated by the phone.

Ecologic Momentary Assessment (EMA)

SCC IIT Office

Lead Nurse

Christina Henson, MD

The purpose of this study is to examine the uses of a mobile health-based assessment and symptom monitoring platform.

This study will involve patients who have been diagnosed with neck or head cancer and are receiving radiation treatments via the QUAD shot regimen. It is a single arm pilot trial designed to provide information on the ease of use, feasibility, and perceived usefulness of a smartphone application to monitor symptoms and quality of life during cancer treatment, as well as assess barriers to care and perceptions of the smartphone app.

Patients will download the study app onto their personal smartphone, if the phone is compatible with the app, or a study smartphone will be loaned to them. The smartphone app will first ask patients to complete the 15-25 minute baseline survey, followed by one daily brief survey that ask about symptoms, quality of life, and barriers for 75 days. At the end of this period, the smartphone app will prompt the patient to complete a final survey, followed by a brief in-person or telephone interview to assess opinions about the app. Patients' symptoms, treatment effects, medication adherence, pain, quality of life, and general barriers to care will be assessed with questionnaires to measure the impacts of the mobile health-based assessment platform. Results from this study will be for research only and will not impact treatment decisions.

Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer

Quality of Life Assessment of Hypofractionated Radiotherapy in Recurrent Head and Neck Cancer: CPC-CT Pilot

Proportion of patients satisfied with the mHealth app. Patient satisfaction will be collected during the follow-up qualitative interview, and data will be analyzed using qualitative methods. The intervention will be deemed feasible if at least 75% of patients report that the app is easy to use and useful. Specifically, we will describe how often the app is used to measure symptoms, treatment effects, medication adherence, and pain, as well as HR-QOL and barriers to care.

Proportion of patients who deem the mHealth app easy to use and useful. To gauge patient perception of mHealth platform with feedback from qualitative interview and app based EMAs. The final survey asks questions on the patients' thoughts, feelings, and opinions about the intervention they received over the course of the study.

Proportion of patients who complete the phone-based surveys. Feasibility of the study will be determined by the proportion of participants who complete \>/=75% of phone-based assessments. The app allows for the completion rate to be quantified.

Proportion of patients who report barriers to care as indicated by feedback from qualitative interview and app based EMAs.

Proportion of changes in weekly FACT-HN scores over time as indicated by feedback from qualitative interview and app based EMAs.

Proportion of daily questionnaires completed as indicated by EMA completion rate.

University of Oklahoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Combination Treatment

* Pembrolizumab by IV once on day 1 of 21 day cycle, begin 7 days before the first round of QUAD SHOT radiotherapy.
* QUAD SHOT radiotherapy twice a day for two days, begin 7 days after the first dose of pembrolizumab; repeat every 28 days for up to 3 rounds.

Maintenance Treatment

* Pembrolizumab by IV once on day 1 of 21 day cycle
* On day 21, if the medical oncologist feels that the patient may safely continue treatment, patient will receive a new 21 days cycle of treatment with pebrolizumab.

Treatment will consist of "QUAD SHOT" radiotherapy combined with pembrolizumab.

Pebrolizumab + QUADSHOT Radiotherapy

Lead Oncology Nurse

Christina Henson, MS

The purpose of this study is to test the safety of palliative "QUAD SHOT" radiotherapy combined with pembrolizumab and evaluate the effects of the combination treatment patients with recurrent cancer of head and neck.

During this study, patients will receive infusions of pembrolizumab with radiotherapy (palliative QUADSHOT regimen). The patient will receive treatment of pembrolizumab once every 3 weeks and palliative "QUAD SHOT" radiotherapy every 4 weeks. These 28 day period of time is called a cycle. The cycle will be repeated 3 times. Each cycle is numbered in order. The patient will be treated for up to 3 cycles followed by pembrolizumab single drug until unacceptable toxicity or tumor progression.

The patient will also complete a survey.

Total duration of the study is up to two years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer	NCT05850663	Head and Neck C...	Ecologic Moment...	18 Years -	University of Oklahoma
Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer	NCT05850663	Head and Neck C...	Ecologic Moment...	18 Years -	University of Oklahoma
"QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer	NCT04373642	Head and Neck C...	Pebrolizumab + ...	18 Years -	University of Oklahoma

Spots Global Cancer Trial Database for quadshot

Every month we try and update this database with for quadshot cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for quadshot

Every month we try and update this database with for quadshot cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for quadshot cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.