Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes

April 4, 2024 updated by: City of Hope Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Questionnaire Administration
Complete questionnaires
Procedure: Patient Monitoring
Undergo remote perioperative telemonitoring
Other Names:
  • monitor
  • medical monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Days 2
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.
Days 7
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.
Days 14
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.
Days 30 after discharge
Retention
Time Frame: Days 2
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 2
Retention
Time Frame: Days 7
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 7
Retention
Time Frame: Days 14
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 14
Retention
Time Frame: Days 30 after discharge
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Days 30 after discharge
Attrition rates
Time Frame: Days 2
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Days 2
Attrition rates
Time Frame: Days 7
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Days 7
Attrition rates
Time Frame: Days 14
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Days 14
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.
Days 30 after discharge
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.
Up to 30 days
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.
Up to 30 days
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
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns, trajectory, and changes in patient-generated health data (PGHD)
Time Frame: Up to 30 days
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
Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups
Time Frame: From pre-surgery to the post-discharge period
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
Time Frame: Up to 30 days after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Laleh Melstrom, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2019

Primary Completion (Estimated)

December 24, 2024

Study Completion (Estimated)

December 24, 2024

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19040 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2020-03377 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage IV Prostate Cancer AJCC v8

Clinical Trials on Questionnaire Administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe