Back to resultsSelf-Management Intervention for Breathlessness in Lung Cancer
Primary Purpose
Lung Cancer, Breathlessness
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-management Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring Lung cancer, Breathlessness, Self-management
Eligibility Criteria
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.
Sites / Locations
- Princess Margaret Hospital/University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self-management Intervention
Standard of care
Arm Description
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.
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
Outcomes
Primary Outcome Measures
Perceived severity of breathlessness
Measured by Numeric Rating Scale for breathlessness intensity.
Affective distress of breathlessness
Measured by Distress of Breathlessness Numerical Rating Scale.
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.
Secondary Outcome Measures
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.
Beliefs about breathlessness
Measured by Symptom Representation Questionnaire.
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
Exercise capacity
Measured by 6-Minute Walk Test.
Psychological distress
Measured by the Hospital Anxiety and Depression Scale.
Quality of life
Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.
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.
Full Information
NCT ID
NCT01585883
First Posted
April 20, 2012
Last Updated
May 2, 2019
Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01585883
Brief Title
Self-Management Intervention for Breathlessness in Lung Cancer
Official Title
A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2011 (Actual)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
December 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Breathlessness
Keywords
Lung cancer, Breathlessness, Self-management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-management Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
Intervention Type
Behavioral
Intervention Name(s)
Self-management Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Perceived severity of breathlessness
Description
Measured by Numeric Rating Scale for breathlessness intensity.
Time Frame
8 weeks
Title
Affective distress of breathlessness
Description
Measured by Distress of Breathlessness Numerical Rating Scale.
Time Frame
8 weeks
Title
Dyspnea with activities of daily living and exercise
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Self-efficacy and mastery for managing breathlessness
Description
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.
Time Frame
8 weeks
Title
Beliefs about breathlessness
Description
Measured by Symptom Representation Questionnaire.
Time Frame
8 weeks
Title
Adherence and Use of Self-Management Strategies
Description
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
Time Frame
8 weeks
Title
Exercise capacity
Description
Measured by 6-Minute Walk Test.
Time Frame
8 weeks
Title
Psychological distress
Description
Measured by the Hospital Anxiety and Depression Scale.
Time Frame
8 weeks
Title
Quality of life
Description
Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.
Time Frame
8 weeks
Title
Health care utilization
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Howell, RN PhD
Organizational Affiliation
Princess Margaret Hospital, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital/University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
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Self-Management Intervention for Breathlessness in Lung Cancer
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