Detecting Activity to Support Healing

Not Applicable

Completed

• Conditions: Colorectal Cancer; Sedentary Lifestyle; Peritoneal Cancer
• Interventions: Behavioral: Sedentary Behavior; Device: Bluetooth-enabled activity monitor

• Registration Number: NCT03211806
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2019-06-06
• Status Verified: 2021-05
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedentary behavior intervention group	Sedentary Behavior	This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts
Monitoring-only group	Bluetooth-enabled activity monitor	This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior
Sedentary behavior intervention group	Bluetooth-enabled activity monitor	This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts

Primary Outcome Measures

Name	Time	Method
Adherence	30-days post-discharge	Percentages of assessments completed and prompts after which steps were detected
Retention	30 days post-discharge	Percentage of those enrolled who completed the program
Acceptability	30-days post-discharge	Post-intervention interviews will be conducted to assess acceptability of the program

Secondary Outcome Measures

Name	Time	Method
Objective physical activity	Change from baseline to 30 days post-discharge	A Bluetooth enabled activity monitor worn throughout the study will estimate of number of steps/day.
Morbidity	30 days post-discharge	Grade 3-4 surgical complications within 30 days after index hospital discharge will be extracted from medical records
Total objective sedentary behavior	Change from baseline to 30 days post-discharge	A Bluetooth enabled activity monitor worn throughout the study will estimate the total amount of time spent in sedentary behavior per day
Mean sedentary behavior bout	Change from baseline to 30 days post-discharge	A Bluetooth enabled activity monitor will be used to estimate mean daily sedentary bout
Patient-reported quality of life	Change from baseline to 30 days post-discharge	Quality of life (FACT)
Readmission	30 days post-discharge	Readmissions within 30 days after index hospital discharge will be extracted from medical records
Patient-reported symptoms	Change from baseline to 30 days post-discharge	Depressive (CES-D) and physical symptom severity (adapted from the MD Anderson Symptom Inventory)
Inflammatory biomarkers	2 weeks post-discharge	Plasma levels of IL-6 and CRP
Maximum sedentary behavior bout	Change from baseline to 30 days post-discharge	A Bluetooth enabled activity monitor will be used to estimate maximum daily sedentary bout

Trial Locations

Locations (1)

UPMC Shadyside; 🇺🇸 Pittsburgh, Pennsylvania, United States