Post-Operative Ambulatory Challenge and Exercise (PACE) Trial

This research study is evaluating the postoperative results in terms of quality of life and functional recovery of elderly patients after cancer surgery.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Mobility Tracker

Detailed Description

This is a pilot study, designed to collect data on steps walked (ambulation) per day of lobectomy patients after surgery. While the investigators know ambulation improves outcomes after surgery, there is no institutional policy, set of patient goals, or method for deciding which patients require further resources, such as physical therapy. Data collected will be used to set up a hospital-wide strategy for patients to achieve post-operative ambulation milestones more readily.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients Aged ≥ 18 years
• Who underwent or who will undergo lung resection at Brigham and Women's Hospital (BWH)
• With diagnosis of malignant or benign disease

Exclusion Criteria:

• Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
• Patients with cognitive deficits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mobility Tracker; Each patient will be provided by the research team staff with a new mobility tracker; The standard pre-operative assessment, surgical procedure and post-operative care will still be done; Measurements of each patient (steps, distance and calories) will be obtained by the research staff	Other: Mobility Tracker; Tracking Patient's movements and calories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Steps Taken	Number of steps taken by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance walked	The distance walked by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.	2 years
Number of Calories Burned	The number of calories burned by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2017
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (ACTUAL): August 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: 17-152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No