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.
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
22
Undergo remote perioperative telemonitoring
Complete questionnaires
City of Hope Medical Center
Duarte, California, United States
Overall accrual
Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 30 after discharge
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Time frame: Days 2
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Time frame: Days 7
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Time frame: Days 14
Retention
Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
Time frame: Days 30 after discharge
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Time frame: Days 2
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Time frame: Days 7
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Time frame: Days 14
Attrition rates
All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 30 days
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
Time frame: 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
Time frame: 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.
Time frame: Up to 30 days after surgery
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