Detecting Activity to Support Healing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Technology to Reduce Sedentary Behavior Before and After Cancer Surgery

Conditions
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Colorectal Cancer, Peritoneal Cancer, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Sedentary Behavior
* Device: Bluetooth-enabled activity monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedentary behavior intervention group<br>This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts | Behavioral: Sedentary Behavior<br>* Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor<br>Device: Bluetooth-enabled activity monitor<br>* Monitoring activity using a Bluetooth-enabled activity monitor<br>|
| Active Comparator: Monitoring-only group<br>This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior | Device: Bluetooth-enabled activity monitor<br>* Monitoring activity using a Bluetooth-enabled activity monitor<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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