Detecting Activity to Support Healing (DASH)

May 21, 2021 updated by: Carissa Low, University of Pittsburgh

Technology to Reduce Sedentary Behavior Before and After Cancer Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Shadyside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Sedentary Behavior
Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor
Device: Bluetooth-enabled activity monitor
Monitoring activity using a Bluetooth-enabled activity monitor
Active Comparator: Monitoring-only group
This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior
Device: Bluetooth-enabled activity monitor
Monitoring activity using a Bluetooth-enabled activity monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: 30 days post-discharge
Percentage of those enrolled who completed the program
30 days post-discharge
Acceptability
Time Frame: 30-days post-discharge
Post-intervention interviews will be conducted to assess acceptability of the program
30-days post-discharge
Adherence
Time Frame: 30-days post-discharge
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
Time Frame: 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
Change from baseline to 30 days post-discharge
Objective physical activity
Time Frame: Change from baseline to 30 days post-discharge
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
Time Frame: Change from baseline to 30 days post-discharge
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
Time Frame: Change from baseline to 30 days post-discharge
Quality of life (FACT)
Change from baseline to 30 days post-discharge
Inflammatory biomarkers
Time Frame: 2 weeks post-discharge
Plasma levels of IL-6 and CRP
2 weeks post-discharge
Morbidity
Time Frame: 30 days post-discharge
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
Time Frame: Change from baseline to 30 days post-discharge
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
Time Frame: Change from baseline to 30 days post-discharge
A Bluetooth enabled activity monitor will be used to estimate maximum daily sedentary bout
Change from baseline to 30 days post-discharge
Readmission
Time Frame: 30 days post-discharge
Readmissions within 30 days after index hospital discharge will be extracted from medical records
30 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2019

Primary Completion (Actual)

May 14, 2021

Study Completion (Actual)

May 14, 2021

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-075
  • K07CA204380 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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