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Completed

NCT Number: NCT01585883

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.

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Key information

Conditions

Lung Cancer Breathlessness Dyspnea Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Hospital/University Health Network

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-management Intervention

Behavioral

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).

Primary outcomes

  1. Perceived severity of breathlessness

    Time frame: 8 weeks

    Measured by Numeric Rating Scale for breathlessness intensity.

  2. Affective distress of breathlessness

    Time frame: 8 weeks

    Measured by Distress of Breathlessness Numerical Rating Scale.

  3. 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.

Secondary outcomes

  1. 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.

  2. Beliefs about breathlessness

    Time frame: 8 weeks

    Measured by Symptom Representation Questionnaire.

  3. 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

  4. Exercise capacity

    Time frame: 8 weeks

    Measured by 6-Minute Walk Test.

  5. Psychological distress

    Time frame: 8 weeks

    Measured by the Hospital Anxiety and Depression Scale.

  6. Quality of life

    Time frame: 8 weeks

    Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.

  7. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 26, 2012
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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