Self-Management Intervention for Breathlessness in Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Health Network, Toronto
Sponsor:
Collaborators:
National Lung Cancer Partnership
Oncology Nursing Society Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01585883
First received: April 20, 2012
Last updated: May 15, 2013
Last verified: April 2013

April 20, 2012
May 15, 2013
May 2012
November 2013   (final data collection date for primary outcome measure)
  • Perceived severity of breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measured by Numeric Rating Scale for breathlessness intensity.
  • Affective distress of breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measured by Distress of Breathlessness Numerical Rating Scale.
  • Dyspnea with activities of daily living and exercise [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01585883 on ClinicalTrials.gov Archive Site
  • Self-efficacy and mastery for managing breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Beliefs about breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measured by Symptom Representation Questionnaire.
  • Adherence and Use of Self-Management Strategies [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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
  • Exercise capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measured by 6-Minute Walk Test.
  • Psychological distress [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measured by the Hospital Anxiety and Depression Scale.
  • Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.
  • Health care utilization [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Self-Management Intervention for Breathlessness in Lung Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Lung Cancer
  • Breathlessness
Behavioral: 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. 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).
  • 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.
    Intervention: Behavioral: Self-management Intervention
  • Active Comparator: Standard of care
    Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
    Intervention: Behavioral: Self-management Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Samantha Mayo 416-340-4800 ext 5605 smayo@uhnresearch.ca
Contact: Doris Howell 416-946-4501 ext 3419 doris.howell@uhn.ca
Canada
 
NCT01585883
Breathlessness Pilot
No
University Health Network, Toronto
University Health Network, Toronto
  • National Lung Cancer Partnership
  • Oncology Nursing Society Foundation
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: Doris Howell, RN PhD Princess Margaret Hospital, University Health Network
University Health Network, Toronto
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP