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Detecting Activity to Support Healing (DASH)

Primary Purpose

Colorectal Cancer, Peritoneal Cancer, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sedentary Behavior
Bluetooth-enabled activity monitor
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Shadyside

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sedentary behavior intervention group

Monitoring-only group

Arm Description

This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts

This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior

Outcomes

Primary Outcome Measures

Retention
Percentage of those enrolled who completed the program
Acceptability
Post-intervention interviews will be conducted to assess acceptability of the program
Adherence
Percentages of assessments completed and prompts after which steps were detected

Secondary Outcome Measures

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
Objective physical activity
A Bluetooth enabled activity monitor worn throughout the study will estimate of number of steps/day.
Patient-reported symptoms
Depressive (CES-D) and physical symptom severity (adapted from the MD Anderson Symptom Inventory)
Patient-reported quality of life
Quality of life (FACT)
Inflammatory biomarkers
Plasma levels of IL-6 and CRP
Morbidity
Grade 3-4 surgical complications within 30 days after index hospital discharge will be extracted from medical records
Mean sedentary behavior bout
A Bluetooth enabled activity monitor will be used to estimate mean daily sedentary bout
Maximum sedentary behavior bout
A Bluetooth enabled activity monitor will be used to estimate maximum daily sedentary bout
Readmission
Readmissions within 30 days after index hospital discharge will be extracted from medical records

Full Information

First Posted
January 23, 2017
Last Updated
May 21, 2021
Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03211806
Brief Title
Detecting Activity to Support Healing
Acronym
DASH
Official Title
Technology to Reduce Sedentary Behavior Before and After Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Peritoneal Cancer, Sedentary Lifestyle

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedentary behavior intervention group
Arm Type
Experimental
Arm Description
This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts
Arm Title
Monitoring-only group
Arm Type
Active Comparator
Arm Description
This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior
Intervention Type
Behavioral
Intervention Name(s)
Sedentary Behavior
Intervention Description
Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor
Intervention Type
Device
Intervention Name(s)
Bluetooth-enabled activity monitor
Intervention Description
Monitoring activity using a Bluetooth-enabled activity monitor
Primary Outcome Measure Information:
Title
Retention
Description
Percentage of those enrolled who completed the program
Time Frame
30 days post-discharge
Title
Acceptability
Description
Post-intervention interviews will be conducted to assess acceptability of the program
Time Frame
30-days post-discharge
Title
Adherence
Description
Percentages of assessments completed and prompts after which steps were detected
Time Frame
30-days post-discharge
Secondary Outcome Measure Information:
Title
Total objective sedentary behavior
Description
A Bluetooth enabled activity monitor worn throughout the study will estimate the total amount of time spent in sedentary behavior per day
Time Frame
Change from baseline to 30 days post-discharge
Title
Objective physical activity
Description
A Bluetooth enabled activity monitor worn throughout the study will estimate of number of steps/day.
Time Frame
Change from baseline to 30 days post-discharge
Title
Patient-reported symptoms
Description
Depressive (CES-D) and physical symptom severity (adapted from the MD Anderson Symptom Inventory)
Time Frame
Change from baseline to 30 days post-discharge
Title
Patient-reported quality of life
Description
Quality of life (FACT)
Time Frame
Change from baseline to 30 days post-discharge
Title
Inflammatory biomarkers
Description
Plasma levels of IL-6 and CRP
Time Frame
2 weeks post-discharge
Title
Morbidity
Description
Grade 3-4 surgical complications within 30 days after index hospital discharge will be extracted from medical records
Time Frame
30 days post-discharge
Title
Mean sedentary behavior bout
Description
A Bluetooth enabled activity monitor will be used to estimate mean daily sedentary bout
Time Frame
Change from baseline to 30 days post-discharge
Title
Maximum sedentary behavior bout
Description
A Bluetooth enabled activity monitor will be used to estimate maximum daily sedentary bout
Time Frame
Change from baseline to 30 days post-discharge
Title
Readmission
Description
Readmissions within 30 days after index hospital discharge will be extracted from medical records
Time Frame
30 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Detecting Activity to Support Healing

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