NCT05038254

Brief Summary

This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

4.7 years

First QC Date

July 30, 2021

Last Update Submit

August 7, 2025

Conditions

Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Metastatic Colon CarcinomaMetastatic Esophageal CarcinomaMetastatic Gastric CarcinomaMetastatic Liver CarcinomaMetastatic Malignant Digestive System NeoplasmMetastatic Malignant Small Intestinal NeoplasmMetastatic Malignant Thoracic NeoplasmMetastatic Pancreatic CarcinomaMetastatic Rectal CarcinomaPathologic Stage IV Esophageal Adenocarcinoma AJCC v8Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Stage IV Colon Cancer AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IV Pancreatic Cancer AJCC v8Stage IV Rectal Cancer AJCC v8Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8Stage IVA Colon Cancer AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVA Rectal Cancer AJCC v8Stage IVB Colon Cancer AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IVB Rectal Cancer AJCC v8Stage IVC Colon Cancer AJCC v8Stage IVC Rectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Rate of acute care visits

    Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.

    Up to 3 months

Secondary Outcomes (3)

  • Change in health-related quality of life (HRQOL)

    Baseline to 6 months

  • Change in patient engagement

    Baseline to 6 months

  • Change in symptom management

    Baseline to 6 months

Study Arms (3)

Arm I (standard of care)

ACTIVE COMPARATOR

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

Other: Best PracticeOther: Questionnaire Administration

Arm II (standard of care, remote monitoring)

EXPERIMENTAL

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

Other: Best PracticeProcedure: Patient MonitoringOther: Questionnaire Administration

Arm III (standard of care, remote monitoring, biometrics)

EXPERIMENTAL

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

Other: Best PracticeProcedure: Patient MonitoringOther: Questionnaire Administration

Interventions

Best PracticeOTHER

Receive standard of care telemedicine

Also known as: standard of care, standard therapy
Arm I (standard of care)Arm II (standard of care, remote monitoring)Arm III (standard of care, remote monitoring, biometrics)
Patient MonitoringPROCEDURE

Undergo remote monitoring

Also known as: medical monitoring, monitor
Arm II (standard of care, remote monitoring)Arm III (standard of care, remote monitoring, biometrics)
Questionnaire AdministrationOTHER

Ancillary studies

Arm I (standard of care)Arm II (standard of care, remote monitoring)Arm III (standard of care, remote monitoring, biometrics)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥ 18 years)
  • English- and Spanish-fluent participants with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either MDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital
  • Their adult (≥18 years) patient-identified or self-identified primary caregivers (MDACC only)
  • Participants may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers of MDACC participants may participate only if the participant consents.

You may not qualify if:

  • Participants who are receiving investigational new drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements.
  • Participants with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison, nursing homes), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Offodile AC 2nd, Delgado D, Lin YL, Geyen D, Miller CJ, Jain S, Finder JP, Shete S, Fossella FV, Overman MJ, Peterson SK. Integration of Remote Symptom and Biometric Monitoring Into the Care of Adult Patients With Cancer Receiving Chemotherapy-A Decentralized Feasibility Pilot Study. JCO Oncol Pract. 2023 Jun;19(6):e811-e821. doi: 10.1200/OP.22.00676. Epub 2023 Feb 23.

    PMID: 36821818DERIVED

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsEsophageal NeoplasmsStomach NeoplasmsCarcinoma, HepatocellularGastrointestinal NeoplasmsPancreatic NeoplasmsRectal Neoplasms

Interventions

Practice Guidelines as TopicStandard of CareRemote Patient Monitoring

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationQuality Indicators, Health CareTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Ryan W Huey, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

September 9, 2021

Study Start

May 12, 2021

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations

US(1)