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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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

Other trials in United States

About this study

Official title: Remote Perioperative Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes

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 groups in NCT04501913
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.

11 Aug 202017 Oct 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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