ACTIVE_NOT_RECRUITING

Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

There Is No Place Like Home- A Pragmatic Effectiveness Trial of Technology-Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

Quick Facts

Study Start:2021-05-12

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05038254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion. * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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 on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion.
* 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.

* 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.

Contacts and Locations

Principal Investigator

Ryan W Huey, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Ryan W Huey, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-12

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2021-05-12

Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IVA Gastric Cancer AJCC v8
Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IVB Gastric Cancer AJCC v8
Metastatic Colon Carcinoma
Metastatic Esophageal Carcinoma
Metastatic Gastric Carcinoma
Metastatic Liver Carcinoma
Metastatic Malignant Digestive System Neoplasm
Metastatic Malignant Small Intestinal Neoplasm
Metastatic Malignant Thoracic Neoplasm
Metastatic Pancreatic Carcinoma
Metastatic Rectal Carcinoma
Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IV Gastric Cancer AJCC v8
Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
Stage IV Colon Cancer AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Stage IV Rectal Cancer AJCC v8
Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8
Stage IVA Colon Cancer AJCC v8
Stage IVA Hepatocellular Carcinoma AJCC v8
Stage IVA Rectal Cancer AJCC v8
Stage IVB Colon Cancer AJCC v8
Stage IVB Hepatocellular Carcinoma AJCC v8
Stage IVB Rectal Cancer AJCC v8
Stage IVC Colon Cancer AJCC v8
Stage IVC Rectal Cancer AJCC v8