NCT03211806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

January 23, 2017

Last Update Submit

May 21, 2021

Conditions

Colorectal CancerPeritoneal CancerSedentary Lifestyle

Outcome Measures

Primary Outcomes (3)

  • Retention

    Percentage of those enrolled who completed the program

    30 days post-discharge

  • Acceptability

    Post-intervention interviews will be conducted to assess acceptability of the program

    30-days post-discharge

  • Adherence

    Percentages of assessments completed and prompts after which steps were detected

    30-days post-discharge

Secondary Outcomes (9)

  • Total objective sedentary behavior

    Change from baseline to 30 days post-discharge

  • Objective physical activity

    Change from baseline to 30 days post-discharge

  • Patient-reported symptoms

    Change from baseline to 30 days post-discharge

  • Patient-reported quality of life

    Change from baseline to 30 days post-discharge

  • Inflammatory biomarkers

    2 weeks post-discharge

  • +4 more secondary outcomes

Study Arms (2)

Sedentary behavior intervention group

EXPERIMENTAL

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

Behavioral: Sedentary BehaviorDevice: Bluetooth-enabled activity monitor

Monitoring-only group

ACTIVE COMPARATOR

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

Device: Bluetooth-enabled activity monitor

Interventions

Sedentary BehaviorBEHAVIORAL

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

Sedentary behavior intervention group
Bluetooth-enabled activity monitorDEVICE

Monitoring activity using a Bluetooth-enabled activity monitor

Monitoring-only groupSedentary behavior intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to read and write in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

  • Low CA, Danko M, Durica KC, Vega J, Li M, Kunta AR, Mulukutla R, Ren Y, Sereika SM, Bartlett DL, Bovbjerg DH, Dey AK, Jakicic JM. A Real-Time Mobile Intervention to Reduce Sedentary Behavior Before and After Cancer Surgery: Pilot Randomized Controlled Trial. JMIR Perioper Med. 2023 Jan 12;6:e41425. doi: 10.2196/41425.

    PMID: 36633893DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsSedentary Behavior

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 23, 2017

First Posted

July 7, 2017

Study Start

June 6, 2019

Primary Completion

May 14, 2021

Study Completion

May 14, 2021

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)