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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014