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A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer

18 Years
Open (Enrolling)
Lung Cancer, Breathlessness

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Trial Information

A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer

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.

Inclusion 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Perceived severity of breathlessness

Outcome Description:

Measured by Numeric Rating Scale for breathlessness intensity.

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Doris Howell, RN PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, University Health Network


Canada: Ethics Review Committee

Study ID:

Breathlessness Pilot



Start Date:

May 2012

Completion Date:

November 2013

Related Keywords:

  • Lung Cancer
  • Breathlessness
  • Lung cancer
  • Breathlessness
  • Self-management
  • Dyspnea
  • Lung Neoplasms