Self-Management Intervention for Breathlessness in Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585883
• Other study ID #: Breathlessness Pilot
• Status: Completed
• Phase: N/A
• Start date: November 30, 2011
• Est. completion date: December 30, 2015

Study information

• Verified date: May 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breathlessness
• Dyspnea
• Lung Cancer
• Lung Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital/University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived severity of breathlessness	Measured by Numeric Rating Scale for breathlessness intensity.	8 weeks
Primary	Affective distress of breathlessness	Measured by Distress of Breathlessness Numerical Rating Scale.	8 weeks
Primary	Dyspnea with activities of daily living and exercise	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.	8 weeks
Secondary	Self-efficacy and mastery for managing breathlessness	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.	8 weeks
Secondary	Beliefs about breathlessness	Measured by Symptom Representation Questionnaire.	8 weeks
Secondary	Adherence and Use of Self-Management Strategies	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	8 weeks
Secondary	Exercise capacity	Measured by 6-Minute Walk Test.	8 weeks
Secondary	Psychological distress	Measured by the Hospital Anxiety and Depression Scale.	8 weeks
Secondary	Quality of life	Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.	8 weeks
Secondary	Health care utilization	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.	8 weeks