Lung CancerNCT01585883
Self-Management Intervention for Breathlessness in Lung Cancer
A study testing Self-management Intervention in people with Lung Cancer and Breathlessness, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Breathlessness
- What is being tested?
- Self-management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2011to 30 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Hospital/University Health Network
Toronto, Ontario
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Breathlessness
- Being tested
- Self-management Intervention
- Keywords
- Lung cancer, Breathlessness, Self-management
- Medical subject headings
- Lung Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Self-management Intervention | Experimental | 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. Receives: Behavioral: Self-management Intervention |
| Standard of care | Active comparator | Patients in this condition will receive usual care as decided by their oncology clinic team or physician. Receives: Behavioral: Self-management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived severity of breathlessness
Measured by Numeric Rating Scale for breathlessness intensity.
Measured: 8 weeks
Affective distress of breathlessness
Measured by Distress of Breathlessness Numerical Rating Scale.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (7)
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.
Measured: 8 weeks
Beliefs about breathlessness
Measured by Symptom Representation Questionnaire.
Measured: 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
Measured: 8 weeks
Exercise capacity
Measured by 6-Minute Walk Test.
Measured: 8 weeks
Psychological distress
Measured by the Hospital Anxiety and Depression Scale.
Measured: 8 weeks
Quality of life
Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study start30 Nov 2011
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Doris Howell, RN PhD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585883
- Sponsor's protocol ID
- Breathlessness Pilot
- Status last verified
- May 2019
- First submitted
- 20 Apr 2012
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer
- ClinicalTrials.gov ID
- NCT01585883
- Acronym / sponsor ID
- Breathlessness Pilot
- Conditions
- Lung Cancer, Breathlessness
- Keywords
- Lung cancer, Breathlessness, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 30 Nov 2011 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management Intervention | Experimental | Behavioral: Self-management InterventionIndividual, 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. |
| Standard of care | Active comparator | Behavioral: Self-management InterventionPatients in this condition will receive usual care as decided by their oncology clinic team or physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management InterventionIndividual, 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). | Behavioural | Self-management Intervention, Standard of care |
Primary outcome
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.
7 secondary outcomes
Self-efficacy and mastery for managing breathlessness
Time frame: 8 weeks
Beliefs about breathlessness
Time frame: 8 weeks
Adherence and Use of Self-Management Strategies
Time frame: 8 weeks
Exercise capacity
Time frame: 8 weeks
Psychological distress
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Health care utilization
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Howell, RN PhD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management Intervention in people with Lung Cancer and Breathlessness, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived severity of breathlessness (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.