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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01063400
• Other study ID #: OS09328
• Status: Terminated
• Phase: N/A
• First received: February 3, 2010
• Last updated: February 10, 2012
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Other:
• Observation
monitoring of physical activity for 14 days using physical activity monitoring devices along with activity diary

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of examining physical activity (through objective measurement devices) and performance status in a 14-day study of lung cancer patients.		14 days	No
Secondary	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.		14 days	No