Ovarian Cancer Clinical Trial
Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
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.
Full 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
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There is 1 Location for this study
Duarte California, 91010, United States
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