Lung Cancer Clinical Trial
Official title:
A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer
Verified date | May 2019 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | December 30, 2015 |
Est. primary completion date | December 30, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: Eligible participants are women and men with lung cancer (stage I to IV) receiving chemotherapy and/or radiotherapy 1. 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 2. Normal cognitive function as measured by a score of <20 on the Short Orientation Memory Cognitive Test (SOMC) 3. ECOG performance score of 0 to 2 4. Estimated life expectancy of >3 months as per physician 5. Reside within a 45 kilometre driving radius of Princess Margaret Hospital 6. Oxygen saturation >90% at rest on room air or with oxygen 7. Available for 8 consecutive weeks of the study. Exclusion criteria: 1. Patients who have received surgery alone as the primary treatment for lung cancer 2. Unstable acute asthma or left heart failure or coronary artery or valvular heart disease or neuromuscular disease 3. Inability to comply with the study protocol including completion of the questionnaires in English 4. Major psychiatric disorder identified by the physician. |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital/University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived severity of breathlessness | Measured by Numeric Rating Scale for breathlessness intensity. | 8 weeks | |
Primary | Affective distress of breathlessness | Measured by Distress of Breathlessness Numerical Rating Scale. | 8 weeks | |
Primary | 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 | 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 | |
Secondary | Beliefs about breathlessness | Measured by Symptom Representation Questionnaire. | 8 weeks | |
Secondary | 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 | |
Secondary | Exercise capacity | Measured by 6-Minute Walk Test. | 8 weeks | |
Secondary | Psychological distress | Measured by the Hospital Anxiety and Depression Scale. | 8 weeks | |
Secondary | Quality of life | Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire. | 8 weeks | |
Secondary | 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 |
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