Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
Study Details
Study Description
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:
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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.
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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.
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To explore the relationship between changes in physiologic health parameter outcomes/PROs and surgical outcomes (postoperative complications, readmissions).
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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
Arms and Interventions
| Arm | 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. |
Procedure: Patient Monitoring
Undergo remote perioperative telemonitoring
Other Names:
Other: Questionnaire Administration
Complete questionnaires
|
Outcome Measures
Primary Outcome Measures
- Overall accrual [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 [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 [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 [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 [Days 2]
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
- Retention [Days 7]
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
- Retention [Days 14]
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
- Retention [Days 30 after discharge]
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
- Attrition rates [Days 2]
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
- Attrition rates [Days 7]
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
- Attrition rates [Days 14]
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
- Attrition rates [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 [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 [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 [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
Secondary Outcome Measures
- Patterns, trajectory, and changes in patient-generated health data (PGHD) [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
- Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups [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
- Changes in PGHD/PROs [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cancer patients diagnosed with GI (esophagus, gastric, colorectal, hepatobiliary) GU (prostate, bladder, renal cell), or GYN (ovarian, endometrial, cervical) cancers
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Patients who are scheduled to undergo major abdominal/pelvic surgery for cancer treatment
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Ability to read and understand English
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We are targeting patients across all stages of disease
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Laleh Melstrom, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19040
- NCI-2020-03377
- 19040
- P30CA033572