DASH: Detecting Activity to Support Healing
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- Adherence [30-days post-discharge]
Percentages of assessments completed and prompts after which steps were detected
Secondary Outcome Measures
- 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
- 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.
- 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)
- Patient-reported quality of life [Change from baseline to 30 days post-discharge]
Quality of life (FACT)
- Inflammatory biomarkers [2 weeks post-discharge]
Plasma levels of IL-6 and CRP
- Morbidity [30 days post-discharge]
Grade 3-4 surgical complications within 30 days after index hospital discharge will be extracted from medical records
- 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
- 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
- Readmission [30 days post-discharge]
Readmissions within 30 days after index hospital discharge will be extracted from medical records
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Shadyside | Pittsburgh | Pennsylvania | United States | 15232 |
Sponsors and Collaborators
- University of Pittsburgh
- National Cancer Institute (NCI)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-075
- K07CA204380