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Lung Cancer | Self-Management Intervention for Breathlessness in Lung Cancer

Lung Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Lung Cancer

Breathlessness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Self-management InterventionIndividual, 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).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Self-management InterventionIndividual, 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.

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

Study Status

Active, not recruiting

Start Date: May 2012

Completed Date: February 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Perceived severity of breathlessness

Secondary Outcome: Self-efficacy and mastery for managing breathlessness

Study sponsors, principal investigator, and references

Principal Investigator: Doris Howell, RN PhD

Lead Sponsor: University Health Network, Toronto

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT01585883

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