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Breathlessness | Improving Management of Breathlessness in Patients With Lung Cancer

Breathlessness research study

What is the primary objective of this study?

Many individuals with lung cancer experience debilitating breathlessness at some point during the course of their illness. Unfortunately, few interventions exist to treat this distressing symptom of cancer. In this study, the investigators plan on recruiting individuals with lung cancer to participate in a behavioral intervention to help relieve breathlessness. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained nurse practitioners in how to deliver the behavioral intervention. The nurse practitioners will meet with patients diagnosed with lung cancer during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. Specifically, the intervention includes education about the relationship between breathlessness and the stress response as well as teaches patients skills for breathing control and relaxation of the body. For this single-group pilot study, the investigators will ask participants to provide feedback about whether they found the intervention acceptable and effective. Participants will also complete questionnaires about their physical and psychological symptoms before and after the intervention in order to measure its effectiveness for treating breathlessness and any distress related to breathlessness. The data from this study will help inform improvements to the intervention in order to make it feasible and effective for treating breathlessness in patients with lung cancer.

Who is eligible to participate?

Inclusion Criteria: - Clinical diagnosis of stage III and IV non-small cell lung cancer (NSCLC) or extensive stage small-cell lung cancer (SCLC) - Must be an adult (age greater than 18 years) - Must receive cancer treatment (radiation or chemotherapy) within the ambulatory clinics of the Massachusetts General Hospital Cancer - Must have an Eastern Cooperative Oncology Performance Status ranging from 0 (asymptomatic) to 2 (symptomatic but in bed less than 50% of time) - Must have moderate breathlessness (i.e., a score of 2 or greater) on the Modified Medical Research Council Dyspnea Scale Exclusion Criteria: - Any untreated major mental illness or neuropsychiatric deficit prohibiting informed consent and/or ability to complete study procedures.

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

Breathlessness

Dyspnea

Lung Cancer

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:Cognitive Behavioral Intervention for BreathlessnessCognitive behavioral intervention for breathlessness, delivered by nurse practitioners during outpatient oncology appointments, in up to 8 patients with advanced lung cancer.

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.

Behavioral Intervention for DyspneaIn the first intervention session, enrolled participants will learn breathing and relaxation exercises designed to relieve breathlessness. The nurse practitioner will also provide handouts with directions for these exercises, an audio-recording with the relaxation exercises, and worksheets for daily home practice. During the second session, participants will again meet with the nurse practitioner to review the study exercises and to address any difficulties participants may have experienced in practicing the skills. All participants will complete questionnaires before and after the study intervention as well as a brief follow-up interview with the research assistant to obtain feedback about ways to improve the intervention to relieve breathlessness in patients with lung cancer.

Study Status

Completed

Start Date: July 2013

Completed Date: November 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Feasibility and acceptability of a nurse practitioner-delivered dyspnea management intervention in patients with advanced lung cancer

Secondary Outcome: Effect of a nurse practitioner-delivered dyspnea management intervention on quality of life in patients with advanced lung cancer

Study sponsors, principal investigator, and references

Principal Investigator: Joseph Greer, Ph.D.

Lead Sponsor: Massachusetts General Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01937637

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