Detecting Activity to Support Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2021-05-14

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.

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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.

Conditions

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Colorectal Cancer Peritoneal Cancer Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sedentary behavior intervention group

This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts

Group Type EXPERIMENTAL

Sedentary Behavior

Intervention Type BEHAVIORAL

Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor

Bluetooth-enabled activity monitor

Intervention Type DEVICE

Monitoring activity using a Bluetooth-enabled activity monitor

Monitoring-only group

This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior

Group Type ACTIVE_COMPARATOR

Bluetooth-enabled activity monitor

Intervention Type DEVICE

Monitoring activity using a Bluetooth-enabled activity monitor

Interventions

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Sedentary Behavior

Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor

Intervention Type BEHAVIORAL

Bluetooth-enabled activity monitor

Monitoring activity using a Bluetooth-enabled activity monitor

Intervention Type DEVICE

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