Clinical trial NCT03211806: Detecting Activity to Support Healing
Official title: Technology to Reduce Sedentary Behavior Before and After Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Peritoneal Cancer
Sedentary Lifestyle
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-07-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research is to develop and test a technology-supported intervention to reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at elevated risk for postoperative complications and readmissions. Sedentary behavior increases markedly after surgery and hospitalization, and reducing sedentary behavior around the time of cancer surgery could reduce risk while also empowering cancer patients to take a more active role in their recovery.

Detailed description: Colorectal or peritoneal cancer patients scheduled for surgical resection (n=60) will be randomized to either the sedentary behavior intervention or monitoring only. The intervention will use a Bluetooth-enabled activity monitor to detect prolonged sedentary bouts, which will prompt a message delivered via smartphone suggesting that patients walk. The intervention will begin at least two weeks prior to scheduled surgery and will continue through the first 30 days at home following hospital discharge. Outcomes will include objective activity and sedentary behavior, patient-reported symptoms and quality of life using standardized instruments, inflammatory biomarkers, and morbidity and hospital readmission 30-days after index discharge.

Eligibility criteria: Inclusion Criteria:

* Scheduled for curative surgical treatment of metastatic colorectal or peritoneal cancer at UPMC Shadyside
* Ability to stand and walk unassisted prior to surgery
* Identified at least two weeks prior to their scheduled surgery date

Exclusion Criteria:

* Unable to read and write in English

Primary outcomes:
measure: Retention
timeFrame: 30 days post-discharge
measure: Acceptability
timeFrame: 30-days post-discharge
measure: Adherence
timeFrame: 30-days post-discharge
Secondary outcomes:
measure: Total objective sedentary behavior
timeFrame: Change from baseline to 30 days post-discharge
measure: Objective physical activity
timeFrame: Change from baseline to 30 days post-discharge
measure: Patient-reported symptoms
timeFrame: Change from baseline to 30 days post-discharge
measure: Patient-reported quality of life
timeFrame: Change from baseline to 30 days post-discharge
measure: Inflammatory biomarkers
timeFrame: 2 weeks post-discharge
measure: Morbidity
timeFrame: 30 days post-discharge
measure: Mean sedentary behavior bout
timeFrame: Change from baseline to 30 days post-discharge
measure: Maximum sedentary behavior bout
timeFrame: Change from baseline to 30 days post-discharge
measure: Readmission
timeFrame: 30 days post-discharge
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
Study officials:
References: