Clinical trial NCT01585883: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Breathlessness
Keywords: Lung cancer
Breathlessness
Self-management
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-04-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived severity of breathlessness
timeFrame: 8 weeks
measure: Affective distress of breathlessness
timeFrame: 8 weeks
measure: Dyspnea with activities of daily living and exercise
timeFrame: 8 weeks
Secondary outcomes:
measure: Self-efficacy and mastery for managing breathlessness
timeFrame: 8 weeks
measure: Beliefs about breathlessness
timeFrame: 8 weeks
measure: Adherence and Use of Self-Management Strategies
timeFrame: 8 weeks
measure: Exercise capacity
timeFrame: 8 weeks
measure: Psychological distress
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
measure: Health care utilization
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital/University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, University Health Network
name: Doris Howell, RN PhD
role: PRINCIPAL_INVESTIGATOR
References: