Clinical Stage IV Esophageal Adenocarcinoma AJCC v8NCT05038254
Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
A study testing Best Practice, Patient Monitoring and Questionnaire Administration in people with Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 and Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8
- What is being tested?
- Best Practice, Patient Monitoring and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 31 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the efficacy of remote patient monitoring (RPM) on improving clinical outcomes.
SECONDARY OBJECTIVE:
- Evaluate the following patient-centered outcomes: treatment delays, health-related quality-of-life (HRQOL), patient activation, and family caregiver-experience.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care consisting of oncology care provided via telemedicine.
ARM II: Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
- 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
- Being tested
- Best Practice, Patient Monitoring, Questionnaire Administration
- Medical subject headings
- Colonic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Gastrointestinal Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care telemedicine
Patient MonitoringProcedure or surgery
Also called medical monitoring, monitor
Undergo remote monitoring
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care) | Active comparator | Patients receive standard of care consisting of oncology care provided via telemedicine. Receives: Other: Best Practice; Other: 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. Receives: Other: Best Practice; Procedure: Patient Monitoring; Other: 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. Receives: Other: Best Practice; Procedure: Patient Monitoring; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (3)
Change in health-related quality of life (HRQOL)
HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1.
Measured: Baseline to 6 months
Change in patient engagement
Patient engagement will be evaluated with the 13-item Patient Activation Measure (PAM), which assesses knowledge, skill, and self-efficacy for self-management of health
Measured: Baseline to 6 months
Change in symptom management
Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start12 May 2021
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan W Huey, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038254
- Sponsor's protocol ID
- 2020-0702
- Other IDs
- NCI-2021-07464, 2020-0702
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36821818