Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Syndrome

Lymphoma

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Cytokine Release Syndrome

Neurotoxicity Syndromes

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Systemic Inflammatory Response Syndrome

Inflammation

Shock

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)

Participants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit.

Telemedicine visit

Rakhee Vaidya, MBBS

The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. The telemedicine visit will use an electronic tablet with a camera and a microphone that allows participants to communicate with their physicians and nurses. Participants will be provided with the necessary equipment to complete these visits.

Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed per patient)

Secondary Objective(s)

* To determine how many times a telemedicine visit triggered an action (inpatient admission/ outpatient observation status)
* To determine how many patients were detected to have cytokine release syndrome and/or neurotoxicity based on their telemedicine visit

Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis

To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment. Investigators will consider telemedicine feasible in this population if at least 13 of the 15 patients successfully complete 80% of telemedicine visits. A visit will be considered successful if all measurements are recorded OR if the visit is interrupted because the participant needs to come into the CAR-T unit for assessment. If a patient is admitted, then the 80% benchmark will be calculated based on the number of days the patient was outpatient at 11 pm. The proportion meeting the 80% benchmark will be reported along with an exact 95% confidence interval.

To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status

Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.

Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.

Wake Forest University Health Sciences

Digestive System Diseases

Behaviors and Mental Disorders

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Quality of Life

Stomach Cancer

Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.

Patients receive standard nutritional support.

Best Practice

Questionnaire Administration

Telemedicine Visit

Jae Y Kim

This clinical trial test whether taking part in a diet support intervention will help with patients nutrition and quality of life after surgery for esophagus or stomach cancer. The information learned by doing this research study may help patients get more information and/or support on eating after esophagus and stomach cancer surgery.

PRIMARY OBJECTIVES:

I. Assess the feasibility, retention, and satisfaction of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention as measured by the percentage of patients who a) agree to participate; b) complete a majority of the intervention (at least 2 sessions); and c) report satisfaction with the intervention (through structured exit interviews).

II. Assess the preliminary efficacy of TIMES for patient reported outcomes for quality of life (QOL), dietary symptoms, and self-management.

III. Assess the preliminary efficacy of TIMES for objective measures of patient nutrition.

OUTLINE: Patients are randomized in to 1 of 2 arms.

ARM I: Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.

ARM II: Patients receive standard nutritional support.

After completion of study, patients are followed up for 6 months.

Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery

Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery

Feasibility of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention will be measured by the percentage of patients who agree to participate.

Feasibility of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention will be measured by the percentage of patients who completes two sessions.

Measured by the percentage of patients who complete a majority of the intervention (at least 2 sessions).

Measured by the percentage of patients who report satisfaction with the intervention (through structured exit interviews). Satisfaction and engagement will be assessed through the exit interview via qualitative data, content analysis approach.

EORTC-QLQ30 will be assessed with a 30-item instrument for QOL assessment, with subscales/items for function, global health, general symptoms (fatigue, pain, nausea, and vomiting), and financial toxicity.

(EORTC-OG25) will be assessed with a 25-item measure for esophagogastric cancer-specific symptoms and emotional well-being.

Patient Activation Measure (PAM) will be assessed by using a Guttman-like scale that reflects a patient's level of engagement and empowerment in their healthcare.

A General Self-Efficacy Scale developed by Jerusalem and colleagues contains 10 items that assess perceived confidence in self-management.

Items are rated on a 4-point Likert scale.

The Post-Gastrectomy Nutrition Questionnaire is a tool developed by the investigators to assess patient knowledge about diet and nutrition after surgery for GE cancer.

Each item addresses specific content discussed in the telehealth sessions to assess changes in knowledge. Scoring is based on the number of questions answered correctly.

Weight will be recorded at baseline and 6 months to examine the preliminary efficacy of the intervention on objective measures of patient nutrition. Weight will be measured by kg.

Body Mass Index will be calculated and recorded by dividing weight in Kg by height in m\^2 at baseline and 6 months to examine the preliminary efficacy of the intervention on objective measures of patient nutrition.

Serum albumin levels collected as routine follow-up care will be recorded at baseline and 6 months to examine the preliminary efficacy of the intervention on objective measures of patient nutrition. Albumin level will be measured g/dl.

Sarcopenia/skeletal muscle mass will be calculated at baseline and 6 months through CT scans performed as part of routine follow-up for gastroesophageal cancer include cross-sectional images at the level of the third lumbar vertebra (L3). The cross-sectional area of skeletal muscle mass in this region has been found in multiple studies to correlate with total body skeletal muscle mass. Skeletal muscle mass will be quantified using well described techniques applying a predefined Hounsfield unit (HU) threshold of -25 to 150 HU for skeletal muscle mass. Muscle boundaries will be corrected manually when necessary to obtain cross-sectional areas (cm2) for skeletal muscle. Skeletal muscle index (SMI, cm2/m2) is defined as the cross-sectional area of muscle at the L3 level normalized for BMI.

National Cancer Institute (NCI)

City of Hope Medical Center

Participants will receive YESCARTA therapy in the outpatient setting

A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.

Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.

Vital sign measurements

Physical exam and review of all available data

Out-Patient Clinic Visit

Participant and their family take their blood pressure and pulse oximeter

Blood pressure and pulse oximeter

Olalekan Oluwole, MD

We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria

Primary Objectives

* To explore the feasibility of treating subjects with YESCARTA in the outpatient setting and guide the development of a subsequent, larger study that will determine the tolerability and safety profile of YESCARTA in the outpatient setting.
* To determine the time to specific interventions post infusion and the number of subjects who remain outpatient through 72 hours, 7, 14, and 30 days.

Secondary Objectives:

* Identify risk factors that preclude outpatient administration, and to obtain clinical data that will guide the development of guidelines by which YESCARTA treatment in the outpatient setting can be done safely.
* Assess the impact of close monitoring with telemedicine and twice-daily physical exam on specific outcomes including CRS and ICANS in subjects treated with YESCARTA in the outpatient setting.
* Cumulative steroid exposure within 28 days post YESCARTA infusion.
* To calculate the estimated cost of YESCARTA administered in the outpatient setting.

Exploratory Objectives:

* Time from YESCARTA infusion to the following: fever, fever with neutropenia, fever without neutropenia.
* Time from fever to Tocilizumab, fever to ICU admission, fever to low BP, fever to IV Fluid, fever to vasopressor, fever to onset to arrhythmias and fever to hospitalization.
* Calculate modified Neutropenic Fever Symptom Burden (NFSB) score for days 1-3 for each subject. Appendix D
* Obtain subject reported outcomes measured by Subject-Reported Outcomes Measurement Information System (PROMIS; Appendix F) \[16, 17\]
* Feasibility of using wearable devices to monitor vital signs in the outpatient setting. Data collected are for research only

Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

Count of participants that require hospitalization

Measured by the number of Cytokine release syndrome events

Measured by the number of Immune effector cell-associated neurotoxicity syndrome events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity	NCT04503538	Large B-cell Ly... Diffuse Large B... Primary Mediast... High-grade B-ce... Follicular Lymp...	Telemedicine vi...	18 Years -	Wake Forest University Health Sciences
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity	NCT04503538	Large B-cell Ly... Diffuse Large B... Primary Mediast... High-grade B-ce... Follicular Lymp...	Telemedicine vi...	18 Years -	Wake Forest University Health Sciences
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery	NCT05203627	Gastric Carcino... Gastroesophagea...	Best Practice Questionnaire A... Telemedicine Vi...	21 Years -	City of Hope Medical Center
Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting	NCT05108805	Large B-cell Ly... Diffuse Large B...	Telemedicine Vi... Vital sign meas... Out-Patient Cli... Blood pressure ...	18 Years -	Vanderbilt-Ingram Cancer Center
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery	NCT05203627	Gastric Carcino... Gastroesophagea...	Best Practice Questionnaire A... Telemedicine Vi...	21 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for telemedicine visit