IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Detecting Activity to Support Healing (DASH)
This study is not yet open for participant recruitment.
Verified July 2017 by Carissa Low, University of Pittsburgh
Sponsor:
University of Pittsburgh
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carissa Low, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03211806
First received: January 23, 2017
Last updated: July 5, 2017
Last verified: July 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
| Colorectal Cancer Peritoneal Cancer Sedentary Lifestyle | Behavioral: Sedentary Behavior Device: Bluetooth-enabled activity monitor |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group Masking: No maskingPrimary Purpose: Supportive Care |
| Official Title: | Technology to Reduce Sedentary Behavior Before and After Cancer Surgery |
Resource links provided by NLM:
Further study details as provided by Carissa Low, University of Pittsburgh:
Primary Outcome Measures:
- Retention [ Time Frame: 30 days post-discharge ]Percentage of those enrolled who completed the program
- Acceptability [ Time Frame: 30-days post-discharge ]Post-intervention interviews will be conducted to assess acceptability of the program
- Adherence [ Time Frame: 30-days post-discharge ]Percentages of assessments completed and prompts after which steps were detected
Secondary Outcome Measures:
- 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
- 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.
- 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)
- Patient-reported quality of life [ Time Frame: Change from baseline to 30 days post-discharge ]Quality of life (FACT)
- Inflammatory biomarkers [ Time Frame: 2 weeks post-discharge ]Plasma levels of IL-6 and CRP
- 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
- 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
- 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
- Readmission [ Time Frame: 30 days post-discharge ]Readmissions within 30 days after index hospital discharge will be extracted from medical records
| Estimated Enrollment: | 60 |
| Anticipated Study Start Date: | July 2017 |
| Estimated Study Completion Date: | July 2019 |
| Estimated Primary Completion Date: | July 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211806
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211806
Contacts
| Contact: Carissa A Low, PhD | (412) 623-5973 | lowca@upmc.edu |
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
More Information
| Responsible Party: | Carissa Low, Assistant Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT03211806 History of Changes |
| Other Study ID Numbers: |
16060549 |
| Study First Received: | January 23, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on July 11, 2017