Detecting Activity to Support Healing

Colorectal Cancer Clinical Trial

— DASH  

Official title:

Technology to Reduce Sedentary Behavior Before and After Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211806
• Other study ID #: 16-075
• Secondary ID: K07CA204380
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: May 14, 2021

Study information

• Verified date: May 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Peritoneal Cancer
• Sedentary Lifestyle

Intervention

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

Locations

Country	Name	City	State
United States	UPMC Shadyside	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Percentage of those enrolled who completed the program	30 days post-discharge
Primary	Acceptability	Post-intervention interviews will be conducted to assess acceptability of the program	30-days post-discharge
Primary	Adherence	Percentages of assessments completed and prompts after which steps were detected	30-days post-discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient-reported quality of life	Quality of life (FACT)	Change from baseline to 30 days post-discharge
Secondary	Inflammatory biomarkers	Plasma levels of IL-6 and CRP	2 weeks post-discharge
Secondary	Morbidity	Grade 3-4 surgical complications within 30 days after index hospital discharge will be extracted from medical records	30 days post-discharge
Secondary	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
Secondary	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
Secondary	Readmission	Readmissions within 30 days after index hospital discharge will be extracted from medical records	30 days post-discharge