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

Active, not recruiting

Conditions: Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIA Gastric Cancer AJCC v8
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVB Gastric Cancer AJCC v8
Malignant Digestive System Neoplasm
Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8

Interventions: Procedure: Patient Monitoring
Other: Questionnaire Administration

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Observational (remote telemonitoring)	Questionnaire Administration	Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.
Observational (remote telemonitoring)	Patient Monitoring	Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.

Primary Outcome Measures

Name	Time	Method
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.
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.
Attrition rates	Days 30 after discharge	All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
Retention	Days 30 after discharge	Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
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

Name	Time	Method
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.
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

Locations (1): City of Hope Medical Center
🇺🇸
Duarte, California, United States