This trial studies how well a Bluetooth-enabled activity monitor works in reducing sedentary behavior before and after surgery in participants with colorectal or peritoneal cancer that has spread to other places in the body. Bluetooth-enabled activity monitors work by detecting prolonged sedentary behavior and may contribute to better postoperative recovery and quality of life following cancer surgery in participants with colorectal or peritoneal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03211806.
PRIMARY OBJECTIVES:
I. Field test and refine a mobile technology-supported real-time sedentary behavior intervention for perioperative cancer patients.
II. Conduct a pilot randomized clinical trial to evaluate the feasibility and acceptability of the mobile technology sedentary behavior intervention in patients scheduled for curative surgical resection of metastatic colorectal or peritoneal cancer, relative to a control group.
III. Examine preliminary effects of the sedentary behavior intervention on (a) objective measures of sedentary behavior and physical activity, (b) patient-reported symptoms and quality of life, (c) circulating inflammatory biomarkers, and (d) 30-day postoperative clinical outcomes (i.e., morbidity and readmission), relative to a monitoring-only control condition.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (SEDENTARY INTERVENTION): Participants wear Bluetooth-enabled activity monitor (LG watch) and are given a smartphone application from two weeks prior to surgery up to 30 days post-discharge. Participants are instructed to complete walking exercise when prolonged sedentary behavior is detected via the Bluetooth-enabled activity monitor. Participants also complete questionnaires over 15-25 minutes and an interview over 5-15 minutes.
GROUP II (MONITORING ONLY): Participants wear Bluetooth-enabled activity monitor and complete questionnaires and interview as in Group I, however participants are not instructed to change sedentary behavior.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorCarissa Low