Perioperative Telemonitoring to Optimize Cancer Care and Outcomes
NCT ID: NCT04986566
Last Updated: 2025-12-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
134 participants
INTERVENTIONAL
2021-10-19
2026-02-07
Brief Summary
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Detailed Description
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I. To conduct a pilot randomized trial of a remote, perioperative telemonitoring intervention to improve patient-centered outcomes, surgical outcomes, and healthcare resource use in English and Spanish-speaking patients scheduled to undergo major abdominal gastrointestinal (GI) cancer surgery.
Ia. Assess the feasibility, retention, and acceptability of the remote perioperative telemonitoring intervention as measured by the percentage of patients who a) agree to participate; b) complete \>= 70% of the telemonitoring; and c) report satisfaction with the intervention through structured exit interviews.
Ib. Determine the preliminary efficacy of the remote perioperative telemonitoring intervention on surgical outcomes, healthcare utilization, patient-reported outcomes (PROs), and functional recovery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TELEMONITORING): Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx application (app) up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures.
ARM II (ENHANCED USUAL CARE): Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (telemonitoring)
Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures.
Best Practice
Use standard reporting procedures
Health Education
Use Aetonixx app
Medical Device Usage and Evaluation
Wear Vivofit 4
Quality-of-Life Assessment
Complete questionnaires
Arm II (enhanced usual care)
Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems.
Best Practice
Use standard reporting procedures
Health Education
Use Aetonixx app
Medical Device Usage and Evaluation
Wear Vivofit 4
Quality-of-Life Assessment
Complete questionnaires
Interventions
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Best Practice
Use standard reporting procedures
Health Education
Use Aetonixx app
Medical Device Usage and Evaluation
Wear Vivofit 4
Quality-of-Life Assessment
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Ability to read and understand English or Spanish
* We are targeting patients across all stages of disease
* Age criterion for this study is based on the National Institute of Health (NIH)'s age criteria, which defines an adult as individuals aged 18 years and over. There are no restrictions related to performance status or life expectancy
* All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institute of Nursing Research (NINR)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Laleh Melstrom
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2021-03335
Identifier Type: REGISTRY
Identifier Source: secondary_id
20717
Identifier Type: OTHER
Identifier Source: secondary_id
20717
Identifier Type: -
Identifier Source: org_study_id
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