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Detecting Activity to Support Healing (DASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211806
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carissa Low, University of Pittsburgh

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
Colorectal Cancer Peritoneal Cancer Sedentary Lifestyle Behavioral: Sedentary Behavior Device: Bluetooth-enabled activity monitor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Technology to Reduce Sedentary Behavior Before and After Cancer Surgery
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Retention [ Time Frame: 30 days post-discharge ]
    Percentage of those enrolled who completed the program

  2. Acceptability [ Time Frame: 30-days post-discharge ]
    Post-intervention interviews will be conducted to assess acceptability of the program

  3. Adherence [ Time Frame: 30-days post-discharge ]
    Percentages of assessments completed and prompts after which steps were detected


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. Patient-reported quality of life [ Time Frame: Change from baseline to 30 days post-discharge ]
    Quality of life (FACT)

  5. Inflammatory biomarkers [ Time Frame: 2 weeks post-discharge ]
    Plasma levels of IL-6 and CRP

  6. 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

  7. 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

  8. 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

  9. Readmission [ Time Frame: 30 days post-discharge ]
    Readmissions within 30 days after index hospital discharge will be extracted from medical records



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211806


Contacts
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Contact: Carissa A Low, PhD (412) 623-5973 lowca@upmc.edu
Contact: Krina C Durica, MA 412-623-7799 duricak@upmc.edu

Locations
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United States, Pennsylvania
UPMC Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Project Manager    412-423-8885    upci.dash@gmail.com   
Principal Investigator: Carissa A Low, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
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Responsible Party: Carissa Low, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03211806    
Other Study ID Numbers: 16-075
K07CA204380 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases