Self-Management Intervention for Breathlessness in Lung Cancer

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention
Lung Cancer
Breathlessness
Behavioral: Self-management Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 56
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
Active Comparator: Standard of care
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585883

Contacts
Contact: Samantha Mayo 416-340-4800 ext 5605 smayo@uhnresearch.ca
Contact: Doris Howell 416-946-4501 ext 3419 doris.howell@uhn.ca

Locations
Canada, Ontario
Princess Margaret Hospital/University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Samantha Mayo    416-340-4800 ext 5605    smayo@uhnresearch.ca   
Sponsors and Collaborators
University Health Network, Toronto
National Lung Cancer Partnership
Oncology Nursing Society Foundation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Doris Howell, RN PhD Princess Margaret Hospital, University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01585883     History of Changes
Other Study ID Numbers: Breathlessness Pilot
Study First Received: April 20, 2012
Last Updated: May 15, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Lung cancer
Breathlessness
Self-management

Additional relevant MeSH terms:
Dyspnea
Lung Neoplasms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on April 17, 2014