- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01585883
Self-Management Intervention for Breathlessness in Lung Cancer
May 2, 2019 updated by: University Health Network, Toronto
A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Princess Margaret Hospital/University Health Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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).
|
Active Comparator: Standard of care
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived severity of breathlessness
Time Frame: 8 weeks
|
Measured by Numeric Rating Scale for breathlessness intensity.
|
8 weeks
|
Affective distress of breathlessness
Time Frame: 8 weeks
|
Measured by Distress of Breathlessness Numerical Rating Scale.
|
8 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy and mastery for managing breathlessness
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
Measured by Symptom Representation Questionnaire.
|
8 weeks
|
Adherence and Use of Self-Management Strategies
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
Measured by 6-Minute Walk Test.
|
8 weeks
|
Psychological distress
Time Frame: 8 weeks
|
Measured by the Hospital Anxiety and Depression Scale.
|
8 weeks
|
Quality of life
Time Frame: 8 weeks
|
Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.
|
8 weeks
|
Health care utilization
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Doris Howell, RN PhD, Princess Margaret Hospital, University Health Network
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2011
Primary Completion (Actual)
December 30, 2015
Study Completion (Actual)
December 30, 2015
Study Registration Dates
First Submitted
April 20, 2012
First Submitted That Met QC Criteria
April 24, 2012
First Posted (Estimate)
April 26, 2012
Study Record Updates
Last Update Posted (Actual)
May 6, 2019
Last Update Submitted That Met QC Criteria
May 2, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breathlessness Pilot
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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