A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Perceived severity of breathlessness
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Self-management Intervention
Individual, face-to-face 7-session self-management intervention delivered by a specialist oncology nurse/clinical case manager as a home-based approach using a manual for each session.
Intervention: Self-management Intervention (Behavioral)
Standard of care
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
Intervention: Self-management Intervention (Behavioral)
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)