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Enhanced Symptom Management for Cancer

N/A

Recruiting

Led By Ryan W Huey, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (>= 18 years) with metastatic thoracic and gastrointestinal (esophagus, stomach, liver, pancreas, small bowel, colon, and rectum) scheduled to initiate outpatient chemotherapy (cycle 1, dose 1) at M D Anderson Cancer Center (MDACC) (Texas Medical Center location)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if providing enhanced symptom management and remote monitoring to patients undergoing chemotherapy can help reduce the number of emergency room visits and hospitalizations.

Who is the study for?

This trial is for adults with metastatic cancers of the thoracic and gastrointestinal regions, starting outpatient chemotherapy at MD Anderson Cancer Center. Caregivers can participate with patient consent. Excluded are those on investigational drugs, in phase 1 trials, requiring inpatient infusion, living in institutions like prisons, or with dementia or disabilities preventing symptom reporting.

What is being tested?

The study tests if enhanced outpatient symptom management using telemedicine and remote monitoring reduces emergency visits due to chemotherapy side effects compared to usual care. It aims for better patient outcomes including quality of life and fewer treatment delays.

What are the potential side effects?

Since this trial focuses on managing symptoms from standard chemotherapy rather than testing new drugs, it doesn't introduce additional side effects beyond those typically expected from chemotherapy such as nausea, fatigue, hair loss, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with cancer in the chest or digestive system starting chemotherapy at MDACC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of acute care visits

Secondary study objectives

Change in health-related quality of life (HRQOL)

Change in patient engagement

Change in symptom management

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (standard of care, remote monitoring, biometrics)Experimental Treatment3 Interventions

Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.

Group II: Arm II (standard of care, remote monitoring)Experimental Treatment3 Interventions

Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.

Group III: Arm I (standard of care)Active Control2 Interventions

Patients receive standard of care consisting of oncology care provided via telemedicine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Monitoring

2019

N/A

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