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Clinical Trials/NCT01585883
NCT01585883
Completed
Not Applicable

A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer

University Health Network, Toronto1 site in 1 country56 target enrollmentNovember 30, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
University Health Network, Toronto
Enrollment
56
Locations
1
Primary Endpoint
Perceived severity of breathlessness
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to investigate the suitability and practicality of a coaching and support intervention in helping patients to use daily strategies for managing breathlessness. Also, the investigators will try to understand how useful it is in helping patients to reduce intensity of breathlessness and its impact their quality of life.

Detailed Description

Lung cancer is common worldwide and is a leading cause of death. Breathlessness (dyspnea or shortness of breath) is a highly prevalent clinical problem in lung cancer, developing early in 25-50% of patients due to advanced stage at presentation. It persists in 60% of survivors' post-lung resection and worsens with progressive disease with rates as high as 90% reported in the final months of life. Breathlessness is associated with a high degree of unpleasantness, negatively impacts on daily functioning, and multiple domains of quality of life, triggers fear and anxiety in patients and their family, and contributes to symptom specific and psychological distress. It is also costly to the health system as it contributes to urgent care use and hospitalization. The purpose of this pilot trial is to evaluate feasibility and acceptability of a self-management intervention for breathlessness in lung cancer.

Registry
clinicaltrials.gov
Start Date
November 30, 2011
End Date
December 30, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Perceived severity of breathlessness

Time Frame: 8 weeks

Measured by Numeric Rating Scale for breathlessness intensity.

Affective distress of breathlessness

Time Frame: 8 weeks

Measured by Distress of Breathlessness Numerical Rating Scale.

Dyspnea with activities of daily living and exercise

Time Frame: 8 weeks

Measured by (a) Chronic Respiratory Questionnaire, (b) Medical Research Council Dyspnea Scale, and (c) BORG scale prior to, during, and at the end of the 6-Minute-Walk Test.

Secondary Outcomes

  • Self-efficacy and mastery for managing breathlessness(8 weeks)
  • Beliefs about breathlessness(8 weeks)
  • Adherence and Use of Self-Management Strategies(8 weeks)
  • Exercise capacity(8 weeks)
  • Psychological distress(8 weeks)
  • Quality of life(8 weeks)
  • Health care utilization(8 weeks)

Study Sites (1)

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