Malignant Neoplasm Clinical Trial
Official title:
Remote Perioperative Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
| Verified date | April 2024 |
| Source | City of Hope Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 22 |
| Est. completion date | December 24, 2024 |
| Est. primary completion date | December 24, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | City of Hope Medical Center | Duarte | California |
| Lead Sponsor | Collaborator |
|---|---|
| City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall accrual | Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients. | Days 2 | |
| Primary | Overall accrual | Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients. | Days 7 | |
| Primary | Overall accrual | Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients. | Days 14 | |
| Primary | Overall accrual | Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients. | Days 30 after discharge | |
| Primary | Retention | Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study. | Days 2 | |
| Primary | Retention | Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study. | Days 7 | |
| Primary | Retention | Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study. | Days 14 | |
| Primary | Retention | Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study. | Days 30 after discharge | |
| Primary | Attrition rates | All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points. | Days 2 | |
| Primary | Attrition rates | All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points. | Days 7 | |
| Primary | Attrition rates | All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points. | Days 14 | |
| Primary | Attrition rates | All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points. | Days 30 after discharge | |
| Primary | 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. | Up to 30 days | |
| Primary | 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. | Up to 30 days | |
| Primary | 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 | Up to 30 days | |
| Secondary | 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 | Up to 30 days | |
| Secondary | 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 | From pre-surgery to the post-discharge period | |
| Secondary | 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. | Up to 30 days after surgery |
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