Self-Management Intervention for Breathlessness in Lung Cancer

NCT ID: NCT01585883

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-12-30

Brief 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.

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.

Conditions

Lung Cancer; Breathlessness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-management Intervention

Intervention Type: 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).

Standard of care

Patients in this condition will receive usual care as decided by their oncology clinic team or physician.

Group Type: ACTIVE_COMPARATOR

Self-management Intervention

Intervention Type: 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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doris Howell, RN PhD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, University Health Network

Locations

Princess Margaret Hospital/University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Breathlessness Pilot

Identifier Type: -

Identifier Source: org_study_id