NCT01078883

Brief Summary

The purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 10, 2011

Status Verified

December 1, 2010

Enrollment Period

1 year

First QC Date

February 28, 2010

Last Update Submit

January 6, 2011

Conditions

Lung Cancer

Keywords

Lung cancerRespiratory muscle strengthDyspneaFunctional capacity

Outcome Measures

Primary Outcomes (1)

  • 1-year respiratory morbidity rate and 1-year mortality rate

    1 year

Secondary Outcomes (1)

  • respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom

    1-2 days

Study Arms (1)

Lung cancer

Patients with primary stage IIIb and IV lung cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary stage IIIb and IV lung cancer

You may qualify if:

  • Clinical diagnosis of stage IIIb/V lung cancer
  • Normal cognition (a Mini Mental State Examination score of more than/equal to 24 points)
  • Able to finish all tests

You may not qualify if:

  • A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsDyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chung-Chun Lai, MS.

    Physical Thaerapy Center, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung-Chun Lai, MS.

CONTACT

886-2-23123456r95428009@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2010

First Posted

March 2, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 10, 2011

Record last verified: 2010-12

Locations

TW(1)