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

This study has been terminated.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01063400
First received: February 3, 2010
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Non Small Cell Lung Cancer
 Other: Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OS09328 Feasibility Study: Comparison of Performance Status With Objective Physical Activity Monitors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Activity monitoring Other: Observation
monitoring of physical activity for 14 days using physical activity monitoring devices along with activity diary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Non-small cell lung cancer patients receiving chemotherapy.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063400

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01063400     History of Changes
Other Study ID Numbers: OS09328
Study First Received: February 3, 2010
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013