Skip to main content
OpenTrials
Completed

NCT Number: NCT03211806

Detecting Activity to Support Healing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Peritoneal Cancer Rectal Diseases Sedentary Behavior Sedentary Lifestyle

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedentary Behavior

Behavioral

Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor

Bluetooth-enabled activity monitor

Device

Monitoring activity using a Bluetooth-enabled activity monitor

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Technology to Reduce Sedentary Behavior Before and After Cancer Surgery

Acronym: DASH

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2017
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.