Improving outpatient care for patients undergoing chemotherapy
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
NA · M.D. Anderson Cancer Center · NCT05038254
This study is testing if using remote monitoring along with regular telemedicine care can help cancer patients manage their symptoms better and reduce emergency visits during chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | CAR-T, chemotherapy, immunotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05038254 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether enhanced outpatient symptom management using telemedicine and remote monitoring can reduce acute care visits caused by chemotherapy-related adverse events. Patients will be randomized into two groups: one receiving standard oncology care via telemedicine and the other receiving the same care along with remote monitoring. The study aims to evaluate the efficacy of remote patient monitoring on clinical outcomes and assess patient-centered outcomes such as quality of life and treatment delays.
Who should consider this trial
Good fit: Ideal candidates include adults with stage IV thoracic and gastrointestinal cancers who are starting or continuing outpatient chemotherapy and can communicate in English or Spanish.
Not a fit: Patients receiving investigational new drug treatments or those enrolled in a phase 1 clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer emergency room visits and hospitalizations for patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown promising results with telemedicine and remote monitoring in managing cancer treatment, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Ryan W Huey, MD — M.D. Anderson Cancer Center
- Study coordinator: Ryan W Huey, MD
- Email: remotemonitoringprogram@mdanderson.org
- Phone: 713-792-2828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: 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