Patient Monitoring for Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma+49 MorePatient Monitoring - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Esophageal Squamous Cell Carcinoma (Stage IV)
  • Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma, Stage IVB
  • Esophageal Squamous Cell Carcinoma (Stage IVA)
  • Esophageal Squamous Cell Carcinoma (Stage IVB)
  • Esophageal Adenocarcinoma
  • Stage IV Colon Cancer
  • Stage IV Gastric Cancer
  • Esophageal Cancer (Stage IV)
  • Esophageal Cancer
  • Stage IVA Gastric Cancer
  • Stomach Cancer
  • Metastatic Malignant Digestive System Cancer
  • Esophageal Squamous Cell Carcinoma Stage IVA
  • Esophageal Squamous Cell Carcinoma Post-Neoadjuvant Therapy Stage IV
  • Stage IV Liver Cancer
  • Stage IV Rectal Cancer
  • Stage IVB Gastric Cancer
  • Postneoadjuvant Therapy Stage IV Gastric Cancer
  • Stage IVB Colon Cancer
  • Lung Cancer
  • Stage IVC Colon Cancer
  • Stage IV Pancreatic Cancer
  • Stage IV Gastrointestinal Stromal Tumor (GIST)
  • Stage IVB Rectal Cancer
  • Colon Cancer
  • Esophageal Adenocarcinoma Postneoadjuvant Therapy Stage IVA AJCC v8
  • Esophageal Squamous Cell Carcinoma
  • Stage IVA Colon Cancer
  • Stage IVA Hepatocellular Carcinoma
  • Metastatic Rectal Cancer
  • Metastatic Pancreatic Endocrine Carcinoma
  • Stage IVA Rectal Cancer
  • Stage IVB Hepatocellular Carcinoma
  • Metastatic Malignant Small Intestinal Cancer
  • Metastatic Liver Cancer
  • Stage IVC Rectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline to 6 months

Baseline to 6 months
Change in health-related quality of life (HRQOL)
Change in patient engagement
Change in symptom management
Up to 3 months
Rate of acute care visits

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm I (standard of care)
1 of 2
Arm II (standard of care, remote monitoring)
1 of 2

Active Control

Experimental Treatment

600 Total Participants · 2 Treatment Groups

Primary Treatment: Patient Monitoring · No Placebo Group · N/A

Arm II (standard of care, remote monitoring)Experimental Group · 3 Interventions: Questionnaire Administration, Patient Monitoring, Best Practice · Intervention Types: Other, Procedure, Other
Arm I (standard of care)ActiveComparator Group · 2 Interventions: Questionnaire Administration, Best Practice · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Monitoring
2019
N/A
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,789,779 Total Patients Enrolled
Anaeze OffodilePrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
600 Total Patients Enrolled
Anaeze Offodile, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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