Feasibility Study: Comparison of Performance Status With Objective Physical Activity Monitors

February 10, 2012 updated by: University of Wisconsin, Madison

OS09328 Feasibility Study: Comparison of Performance Status With Objective Physical Activity Monitors

The purpose of this research is to examine the relationship between performance status rating and the actual amount of physical activity a subject does when it is measured by an activity monitor.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-small cell lung cancer patients receiving chemotherapy.

Description

Inclusion Criteria:

  • Worst Daily Pain rating of < 4/10
  • ECOG Performance Status of 0, 1, or 2
  • Prior malignancy is allowed as long as it is inactive or well-controlled without current anti-tumor therapy required

Exclusion Criteria:

  • Known brain metastasis
  • Use of assistive devices (cane, crutch)
  • No concurrent radiotherapy: all radiotherapy must be completed 4 weeks prior to enrollment in this study
  • Patients receiving only targeted therapy are not eligible(e.g.erlotinib)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Activity monitoring
Other: Observation
monitoring of physical activity for 14 days using physical activity monitoring devices along with activity diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the feasibility of examining physical activity (through objective measurement devices) and performance status in a 14-day study of lung cancer patients.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the number of days of monitoring necessary to reliably estimate energy expenditure (steps/day, and % of time spent sedentary) in lung cancer patients undergoing chemotherapy.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Toby Campbell, MD, UW Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 10, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS09328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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