Overview

This trial is active, not recruiting.

Conditions lung cancer, breathlessness
Treatment self-management intervention
Sponsor University Health Network, Toronto
Collaborator Canadian Institutes of Health Research (CIHR)
Start date May 2012
End date February 2017
Trial size 56 participants
Trial identifier NCT01585883, Breathlessness Pilot

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
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)
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
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).

Primary Outcomes

Measure
Perceived severity of breathlessness
time frame: 8 weeks
Affective distress of breathlessness
time frame: 8 weeks
Dyspnea with activities of daily living and exercise
time frame: 8 weeks

Secondary Outcomes

Measure
Self-efficacy and mastery for managing breathlessness
time frame: 8 weeks
Beliefs about breathlessness
time frame: 8 weeks
Adherence and Use of Self-Management Strategies
time frame: 8 weeks
Exercise capacity
time frame: 8 weeks
Psychological distress
time frame: 8 weeks
Quality of life
time frame: 8 weeks
Health care utilization
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer
Principal investigator Doris Howell, RN PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.