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Clinical Trials/NCT03211806
NCT03211806
Completed
Not Applicable

Technology to Reduce Sedentary Behavior Before and After Cancer Surgery

University of Pittsburgh1 site in 1 country26 target enrollmentJune 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
University of Pittsburgh
Enrollment
26
Locations
1
Primary Endpoint
Adherence
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2019
End Date
May 14, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carissa Low

Assistant Professor

University of Pittsburgh

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

Outcomes

Primary Outcomes

Adherence

Time Frame: 30-days post-discharge

Percentages of assessments completed and prompts after which steps were detected

Retention

Time Frame: 30 days post-discharge

Percentage of those enrolled who completed the program

Acceptability

Time Frame: 30-days post-discharge

Post-intervention interviews will be conducted to assess acceptability of the program

Secondary Outcomes

  • Objective physical activity(Change from baseline to 30 days post-discharge)
  • Morbidity(30 days post-discharge)
  • Total objective sedentary behavior(Change from baseline to 30 days post-discharge)
  • Mean sedentary behavior bout(Change from baseline to 30 days post-discharge)
  • Patient-reported quality of life(Change from baseline to 30 days post-discharge)
  • Readmission(30 days post-discharge)
  • Patient-reported symptoms(Change from baseline to 30 days post-discharge)
  • Inflammatory biomarkers(2 weeks post-discharge)
  • Maximum sedentary behavior bout(Change from baseline to 30 days post-discharge)

Study Sites (1)

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