Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
Official Title
Remote Perioperative Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
Acronym
Not provided
Organization
City of Hope Medical CenterOTHER
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 24, 2019Actual
Primary Completion Date
Oct 17, 2025Actual
Completion Date
Oct 17, 2025Actual
First Submitted Date
May 21, 2020
First Submission Date that Met QC Criteria
Aug 3, 2020
First Posted Date
Aug 6, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 3, 2025
Last Update Posted Date
Dec 5, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
City of Hope Medical CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief 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. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.
Detailed Description
PRIMARY OBJECTIVES:
I. 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.
Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.
Procedure: Patient Monitoring
Other: Questionnaire Administration
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Patient Monitoring
Procedure
Undergo remote perioperative telemonitoring
Observational (remote telemonitoring)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall accrual
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
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.
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.
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.
Days 30 after discharge
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 2
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 7
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 14
Retention
Secondary Outcomes
Measure
Description
Time Frame
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
Up to 30 days
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder 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
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 30 after discharge
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Days 2
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Days 7
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Days 14
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
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.
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.
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
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
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.
Up to 30 days after surgery
ID
Term
D005770
Gastrointestinal Neoplasms
D014565
Urogenital Neoplasms
D009369
Neoplasms
D015179
Colorectal Neoplasms
D001749
Urinary Bladder Neoplasms
D002583
Uterine Cervical Neoplasms
D010051
Ovarian Neoplasms
D011471
Prostatic Neoplasms
D002292
Carcinoma, Renal Cell
Ancestor Terms
ID
Term
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications