Self-Management Intervention for Breathlessness in Lung Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer, Breathlessness

Intervention / Treatment
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* Behavioral: Self-management Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Eligible participants are women and men with lung cancer (stage I to IV) receiving chemotherapy and/or radiotherapy Report breathlessness occurrence (any score >=3) on a Numerical Rating Scale (0-no breathlessness; 10 - worst breathlessness) during standardized routine distress screening and/or report breathlessness as a symptom to their health care provider Normal cognitive function as measured by a score of <20 on the Short Orientation Memory Cognitive Test (SOMC) ECOG performance score of 0 to 2 Estimated life expectancy of >3 months as per physician Reside within a 45 kilometre driving radius of Princess Margaret Hospital Oxygen saturation >90% at rest on room air or with oxygen Available for 8 consecutive weeks of the study. Exclusion criteria: Patients who have received surgery alone as the primary treatment for lung cancer Unstable acute asthma or left heart failure or coronary artery or valvular heart disease or neuromuscular disease Inability to comply with the study protocol including completion of the questionnaires in English Major psychiatric disorder identified by the physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-management Intervention<br>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. | Behavioral: Self-management Intervention<br>* 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. The intervention is delivered through scheduled home visits (7 sessions about one-hour in length), telephone coaching (2 sessions/week to reinforce use of strategies and for symptom monitoring: 15 minutes), and nurse moderated online peer chat or chat that is self-initiated at other times (7 weekly sessions about one hour in length).<br>|
| Active Comparator: Standard of care<br>Patients in this condition will receive usual care as decided by their oncology clinic team or physician. | Behavioral: Self-management Intervention<br>* 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. The intervention is delivered through scheduled home visits (7 sessions about one-hour in length), telephone coaching (2 sessions/week to reinforce use of strategies and for symptom monitoring: 15 minutes), and nurse moderated online peer chat or chat that is self-initiated at other times (7 weekly sessions about one hour in length).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived severity of breathlessness | Measured by Numeric Rating Scale for breathlessness intensity. | 8 weeks | 
| Affective distress of breathlessness | Measured by Distress of Breathlessness Numerical Rating Scale. | 8 weeks | 
| Dyspnea with activities of daily living and exercise | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy and mastery for managing breathlessness | Measured by (a) individual self-report items for self-efficacy for managing shortness of breath and self-efficacy for exercise from the toolkit of Stanford measures; (b) Chronic Respiratory Questionnaire - Mastery subscale; (c) adapted COPD Self-Efficacy Scale developed for this study. | 8 weeks | 
| Beliefs about breathlessness | Measured by Symptom Representation Questionnaire. | 8 weeks | 
| Adherence and Use of Self-Management Strategies | Measured using (1) Daily activity log of physical activity;(2)Seven-Day Physical Activity Recall tool (7-day PAR);(3) Cognitive Symptom Management Scale;(4) Daily tracking log of self-management strategies | 8 weeks | 
| Exercise capacity | Measured by 6-Minute Walk Test. | 8 weeks | 
| Psychological distress | Measured by the Hospital Anxiety and Depression Scale. | 8 weeks | 
| Quality of life | Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire. | 8 weeks | 
| Health care utilization | Measured by three questions derived from the Stanford Self-Management Program Toolkit of Measures, regarding number of hospital days, emergency room visits, and visits to physicians related to their breathlessness. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Breathlessness, Self-management