Active — Not RecruitingNot Applicable

Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

United States134 participantsStarted 2021-10-19

Plain-language summary

This study aims to see whether an at-home monitoring program that collects health, symptoms, and quality of life data in real-time can be included as part of the care of surgery patients in order to provide better recovery. Patient-generated health data (weight, temperature, oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4 watch) and smart device applications are used more and more to measure value and quality in cancer care. However, measuring patient-generated health data is not currently part of standard care following cancer surgery. An at-home monitoring program may improve the care of patients after hospital discharge from surgery and may help reduce complications by identifying issues early.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cancer patients scheduled to undergo major abdominal surgery for gastrointestinal (GI) malignancies. GI procedures include esophagectomy, gastrectomy, colectomy, abdominoperineal resection/low anterior resection, hepatectomy, pancreatectomy (distal or pancreaticoduodenectomy), and cytoreductive surgery for peritoneal carcinomatosis. We will include patients scheduled for an ostomy (colostomy or diverting ileostomy) * 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: * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

What they're measuring

Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)

Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

Number of Participants Who Completed >= 70% of the Study

Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

Number of Participants Who Reported Intervention Acceptability

Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

Trial details

NCT IDNCT04986566

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

Results submitted2025-08-14

View on ClinicalTrials.gov More Malignant Digestive System Neoplasm trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)

Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

Number of Participants Who Completed >= 70% of the Study

Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

Number of Participants Who Reported Intervention Acceptability

Timeframe: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).