Clinical trial NCT04501913: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8
Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage 0 Gastric Cancer AJCC v8
Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage I Gastric Cancer AJCC v8
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage II Gastric Cancer AJCC v8
Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIA Gastric Cancer AJCC v8
Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIB Gastric Cancer AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage III Gastric Cancer AJCC v8
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IVA Gastric Cancer AJCC v8
Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IVB Gastric Cancer AJCC v8
Hepatobiliary Neoplasm
Malignant Digestive System Neoplasm
Malignant Female Reproductive System Neoplasm
Malignant Genitourinary System Neoplasm
Malignant Neoplasm
Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8
Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage 0 Gastric Cancer AJCC v8
Pathologic Stage I Esophageal Adenocarcinoma AJCC v8
Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage I Gastric Cancer AJCC v8
Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IA Gastric Cancer AJCC v8
Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IB Gastric Cancer AJCC v8
Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8
Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage II Gastric Cancer AJCC v8
Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IIA Gastric Cancer AJCC v8
Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IIB Gastric Cancer AJCC v8
Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage III Gastric Cancer AJCC v8
Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IIIA Gastric Cancer AJCC v8
Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IIIB Gastric Cancer AJCC v8
Pathologic Stage IIIC Gastric Cancer AJCC v8
Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IV Gastric Cancer AJCC v8
Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
Stage 0 Colorectal Cancer AJCC v8
Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
Stage I Cervical Cancer AJCC v8
Stage I Colorectal Cancer AJCC v8
Stage I Ovarian Cancer AJCC v8
Stage I Prostate Cancer AJCC v8
Stage I Renal Cell Cancer AJCC v8
Stage I Uterine Corpus Cancer AJCC v8
Stage IA Cervical Cancer AJCC v8
Stage IA Ovarian Cancer AJCC v8
Stage IA Uterine Corpus Cancer AJCC v8
Stage IA1 Cervical Cancer AJCC v8
Stage IA2 Cervical Cancer AJCC v8
Stage IB Cervical Cancer AJCC v8
Stage IB Ovarian Cancer AJCC v8
Stage IB Uterine Corpus Cancer AJCC v8
Stage IB1 Cervical Cancer AJCC v8
Stage IB2 Cervical Cancer AJCC v8
Stage IC Ovarian Cancer AJCC v8
Stage II Bladder Cancer AJCC v8
Stage II Cervical Cancer AJCC v8
Stage II Colorectal Cancer AJCC v8
Stage II Ovarian Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage II Renal Cell Cancer AJCC v8
Stage II Uterine Corpus Cancer AJCC v8
Stage IIA Cervical Cancer AJCC v8
Stage IIA Colorectal Cancer AJCC v8
Stage IIA Ovarian Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIA1 Cervical Cancer AJCC v8
Stage IIA2 Cervical Cancer AJCC v8
Stage IIB Cervical Cancer AJCC v8
Stage IIB Colorectal Cancer AJCC v8
Stage IIB Ovarian Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
Stage IIC Colorectal Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Bladder Cancer AJCC v8
Stage III Cervical Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage III Renal Cell Cancer AJCC v8
Stage III Uterine Corpus Cancer AJCC v8
Stage IIIA Bladder Cancer AJCC v8
Stage IIIA Cervical Cancer AJCC v8
Stage IIIA Colorectal Cancer AJCC v8
Stage IIIA Ovarian Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIA Uterine Corpus Cancer AJCC v8
Stage IIIA1 Ovarian Cancer AJCC v8
Stage IIIA2 Ovarian Cancer AJCC v8
Stage IIIB Bladder Cancer AJCC v8
Stage IIIB Cervical Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Stage IIIB Ovarian Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIB Uterine Corpus Cancer AJCC v8
Stage IIIC Colorectal Cancer AJCC v8
Stage IIIC Ovarian Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Stage IIIC Uterine Corpus Cancer AJCC v8
Stage IIIC1 Uterine Corpus Cancer AJCC v8
Stage IIIC2 Uterine Corpus Cancer AJCC v8
Stage IV Bladder Cancer AJCC v8
Stage IV Cervical Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Stage IV Uterine Corpus Cancer AJCC v8
Stage IVA Bladder Cancer AJCC v8
Stage IVA Cervical Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVA Ovarian Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVA Uterine Corpus Cancer AJCC v8
Stage IVB Bladder Cancer AJCC v8
Stage IVB Cervical Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVB Ovarian Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Stage IVB Uterine Corpus Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Overall accrual
timeFrame: Days 2
measure: Overall accrual
timeFrame: Days 7
measure: Overall accrual
timeFrame: Days 14
measure: Overall accrual
timeFrame: Days 30 after discharge
measure: Retention
timeFrame: Days 2
measure: Retention
timeFrame: Days 7
measure: Retention
timeFrame: Days 14
measure: Retention
timeFrame: Days 30 after discharge
measure: Attrition rates
timeFrame: Days 2
measure: Attrition rates
timeFrame: Days 7
measure: Attrition rates
timeFrame: Days 14
measure: Attrition rates
timeFrame: Days 30 after discharge
measure: Patient's ability to use the remote perioperative monitoring equipment
timeFrame: Up to 30 days
measure: Staff ability to identify threshold healthcare parameters
timeFrame: Up to 30 days
measure: Staff ability to act on identified threshold healthcare parameters
timeFrame: Up to 30 days
Secondary outcomes:
measure: Patterns, trajectory, and changes in patient-generated health data (PGHD)
timeFrame: Up to 30 days
measure: Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups
timeFrame: From pre-surgery to the post-discharge period
measure: Changes in PGHD/PROs
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Laleh Melstrom
role: PRINCIPAL_INVESTIGATOR
References: