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

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ClinicalTrials.gov Identifier: NCT01063400
Recruitment Status : Terminated (lack of funding)
First Posted : February 5, 2010
Last Update Posted : February 14, 2012
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Other: Observation

Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OS09328 Feasibility Study: Comparison of Performance Status With Objective Physical Activity Monitors
Study Start Date : January 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-small cell lung cancer patients receiving chemotherapy.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063400

United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Toby Campbell, MD UW Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01063400     History of Changes
Other Study ID Numbers: OS09328
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases