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

NCT01063400 | Terminated DMC

• 1 other identifier: OS09328
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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.

  14 days

Secondary Outcomes (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.

  14 days

Study Arms (1)

Activity monitoring

Other: Observation

Interventions

Observation OTHER

monitoring of physical activity for 14 days using physical activity monitoring devices along with activity diary

Activity monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-small cell lung cancer patients receiving chemotherapy.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Toby Campbell, MD

  UW Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)