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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05038254
- Acronym / sponsor ID
- 2020-0702
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive standard of care consisting of oncology care provided via telemedicine. |
| Arm II (standard of care, remote monitoring) | Experimental | Other: Best Practice, Procedure: Patient Monitoring, Other: Questionnaire AdministrationPatients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring. |
| Arm III (standard of care, remote monitoring, biometrics) | Experimental | Other: Best Practice, Procedure: Patient Monitoring, Other: Questionnaire AdministrationPatient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care telemedicine | Other | Arm I (standard of care), Arm II (standard of care, remote monitoring), Arm III (standard of care, remote monitoring, biometrics) |
| Patient MonitoringAlso: medical monitoring, monitorUndergo remote monitoring | Procedure or surgery | Arm II (standard of care, remote monitoring), Arm III (standard of care, remote monitoring, biometrics) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard of care), Arm II (standard of care, remote monitoring), Arm III (standard of care, remote monitoring, biometrics) |
Primary outcome
Rate of acute care visits
Time frame: Up to 3 months
Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.
3 secondary outcomes
Change in health-related quality of life (HRQOL)
Time frame: Baseline to 6 months
Change in patient engagement
Time frame: Baseline to 6 months
Change in symptom management
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Derived from this study: PubMed 36821818Offodile 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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan W Huey, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute care visits (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.