Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8NCT04501913
Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
An observational study of Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8 and Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage 0 Gastric Cancer AJCC v8
- What is being tested?
- Patient Monitoring and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 17 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Cancer patients diagnosed with gastrointestinal, genitourinary, or gynecological cancers who are scheduled to undergo abdominal/pelvic surgery at the City of Hope National Medical Center
Who may be able to join
- Cancer patients diagnosed with GI (esophagus, gastric, colorectal, hepatobiliary) GU (prostate, bladder, renal cell), or GYN (ovarian, endometrial, cervical) cancers
- Patients who are scheduled to undergo major abdominal/pelvic surgery for cancer treatment
- Ability to read and understand English
- We are targeting patients across all stages of disease
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Who cannot join
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Remote Perioperative Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
This study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and acceptability of remote perioperative monitoring in solid tumor cancer patients scheduled for gastrointestinal (GI), genitourinary (GU), gynecological (GYN) cancer surgery.
II. To explore patterns, trajectory, and changes in physiologic health parameter outcomes (weight, temperature, oxygen saturation, heart rate, blood pressure, daily steps) and patient-reported outcomes (PROs) (symptoms, quality of life [QOL]) from pre-surgery to the post-discharge period.
III. To explore the relationship between changes in physiologic health parameter outcomes/PROs and surgical outcomes (postoperative complications, readmissions).
IV. To explore changes in physiologic health parameters and PROs by open surgery versus minimally invasive (laparoscopic or robotic) surgery.
OUTLINE:
Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.
After completion of study, patients are followed up for 2 months.
- Conditions
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
- Being tested
- Patient Monitoring, Questionnaire Administration
- Medical subject headings
- Gastrointestinal Neoplasms, Urogenital Neoplasms, Neoplasms, Colorectal Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient MonitoringProcedure or surgery
Also called medical monitoring, monitor
Undergo remote perioperative telemonitoring
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (remote telemonitoring) | Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge. Receives: Procedure: Patient Monitoring; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall accrual
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Measured: Days 2
Overall accrual
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Measured: Days 7
Overall accrual
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Measured: Days 14
Overall accrual
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Measured: Days 30 after discharge
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Measured: Days 2
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Measured: Days 7
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Measured: Days 14
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Measured: Days 30 after discharge
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Measured: Days 2
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Measured: Days 7
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Measured: Days 14
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Measured: Days 30 after discharge
Patient's ability to use the remote perioperative monitoring equipment
At least 75% of patients will be able to wear the wristband pedometer for at least 1 week post-operatively, and at least 75% of the patients will be able to use at least 2 out of 4 physiologic devices (scale, pulse/heart monitor, blood pressure cuff, and thermometer) at least once a week.
Measured: Up to 30 days
Staff ability to identify threshold healthcare parameters
Staff will be alerted through a workflow guided by the threshold healthcare parameters. The number of alerts of data outside parameters will be recorded as well as the initiated response to each alert.
Measured: Up to 30 days
Staff ability to act on identified threshold healthcare parameters
The number of alerts and resolved alerts will be captured in response to threshold parameters in addition to a nurse debriefing form to summarize the response
Measured: Up to 30 days
Secondary outcomes (3)
Patterns, trajectory, and changes in patient-generated health data (PGHD)
After discharge, all patient-generated physiologic data will be repeated at day 7,14,,and day 30 to measure any differences in weight, temperature, oxygen saturation, heart rate, blood pressure and functional activity using the Aetonix devices and Vivofit watches
Measured: Up to 30 days
Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups
Quality of Life will be measured through the EQ-5D-5L and PROMIS 4 QOL measurement tools
Measured: From pre-surgery to the post-discharge period
Changes in PGHD/PROs
Distributions of PGHD/PROs will be generated. Means, standard deviations, and ranges will be calculated for continuous variables, and frequencies and percentages for categorical variables. All PROs will be scored according to instructions. Analysis of variance (ANOVA) will be used to study patterns of change over time in PROs administered at multiple time points.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start11 Aug 2020
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laleh Melstrom, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501913
- Sponsor's protocol ID
- 19040
- Other IDs
- NCI-2020-03377, 19040, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 21 May 2020
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Perioperative Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT04501913
- Acronym / sponsor ID
- 19040
- Conditions
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 6 Aug 2020 (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 study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and acceptability of remote perioperative monitoring in solid tumor cancer patients scheduled for gastrointestinal (GI), genitourinary (GU), gynecological (GYN) cancer surgery.
II. To explore patterns, trajectory, and changes in physiologic health parameter outcomes (weight, temperature, oxygen saturation, heart rate, blood pressure, daily steps) and patient-reported outcomes (PROs) (symptoms, quality of life [QOL]) from pre-surgery to the post-discharge period.
III. To explore the relationship between changes in physiologic health parameter outcomes/PROs and surgical outcomes (postoperative complications, readmissions).
IV. To explore changes in physiologic health parameters and PROs by open surgery versus minimally invasive (laparoscopic or robotic) surgery.
OUTLINE:
Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.
After completion of study, patients are followed up for 2 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (remote telemonitoring) | – | Procedure: Patient Monitoring, Other: Questionnaire AdministrationPatients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients diagnosed with gastrointestinal, genitourinary, or gynecological cancers who are scheduled to undergo abdominal/pelvic surgery at the City of Hope National Medical Center
Key inclusion criteria (5 listed)
- Cancer patients diagnosed with GI (esophagus, gastric, colorectal, hepatobiliary) GU (prostate, bladder, renal cell), or GYN (ovarian, endometrial, cervical) cancers
- Patients who are scheduled to undergo major abdominal/pelvic surgery for cancer treatment
- Ability to read and understand English
- We are targeting patients across all stages of disease
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (1 listed)
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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 |
|---|---|---|
| Patient MonitoringAlso: medical monitoring, monitorUndergo remote perioperative telemonitoring | Procedure or surgery | Observational (remote telemonitoring) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (remote telemonitoring) |
Primary outcome
Overall accrual
Time frame: Days 2
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Overall accrual
Time frame: Days 7
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Overall accrual
Time frame: Days 14
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Overall accrual
Time frame: Days 30 after discharge
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Retention
Time frame: Days 2
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Retention
Time frame: Days 7
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Retention
Time frame: Days 14
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Retention
Time frame: Days 30 after discharge
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Attrition rates
Time frame: Days 2
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Attrition rates
Time frame: Days 7
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Attrition rates
Time frame: Days 14
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Attrition rates
Time frame: Days 30 after discharge
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Patient's ability to use the remote perioperative monitoring equipment
Time frame: Up to 30 days
At least 75% of patients will be able to wear the wristband pedometer for at least 1 week post-operatively, and at least 75% of the patients will be able to use at least 2 out of 4 physiologic devices (scale, pulse/heart monitor, blood pressure cuff, and thermometer) at least once a week.
Staff ability to identify threshold healthcare parameters
Time frame: Up to 30 days
Staff will be alerted through a workflow guided by the threshold healthcare parameters. The number of alerts of data outside parameters will be recorded as well as the initiated response to each alert.
Staff ability to act on identified threshold healthcare parameters
Time frame: Up to 30 days
The number of alerts and resolved alerts will be captured in response to threshold parameters in addition to a nurse debriefing form to summarize the response
3 secondary outcomes
Patterns, trajectory, and changes in patient-generated health data (PGHD)
Time frame: Up to 30 days
Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups
Time frame: From pre-surgery to the post-discharge period
Changes in PGHD/PROs
Time frame: Up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
Laleh Melstrom principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8 and Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, run by City of Hope Medical 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 1 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: finished, as of the sponsor's last update on 14 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall accrual (time frame: Days 2). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.