Clinical trial NCT03089125: Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Official title: Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Dana-Farber Cancer Institute
First posted: 2017-03-24
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nurse administered dyspnea intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is evaluating a behavioral intervention designed to help people with advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).

Detailed description: Many individuals with advanced 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.

The purpose of this study is to test the efficacy of a brief behavioral intervention may help relieve breathlessness in individuals with advanced lung cancer. Participants will have a 50/50 chance of receiving the behavioral intervention or standard care. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained oncology nurses in how to deliver the behavioral intervention. The oncology nurses will meet with participants during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. This intervention involves no medications but rather teaches patients skills for breathing control and relaxation of the body.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of either NSCLC, SCLC, or mesothelioma, not being treated with curative intent
* Self-reported shortness of breath (a score of 2 or greater on the Modified Medical Research Council Dyspnea Scale)
* Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed \<50% of day)
* The ability to read and respond to questions English
* Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI)
* Age \>18 years

Exclusion Criteria:

* Cognitive or psychiatric conditions prohibiting study consent or participation.
* A treating clinician who reports that the patient is inappropriate for the study

Primary outcomes:
measure: Modified Medical Research Council Dyspnea Scale (mMRCDS)
timeFrame: 8 weeks
measure: Cancer Dyspnoea Scale (CDS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Lung (FACT-L)
timeFrame: 8 weeks
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
timeFrame: 8 weeks
measure: Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
timeFrame: 8 weeks
measure: Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)
timeFrame: 8 weeks
measure: Activity Level (Objective Measure: Actigraphy)
timeFrame: 8 weeks
Other outcomes:
measure: Modified Medical Research Council Dyspnea Scale (mMRCDS)
timeFrame: 24 weeks
measure: Cancer Dyspnoea Scale (CDS)
timeFrame: 24 weeks
measure: Functional Assessment of Cancer Therapy - Lung (FACT-L)
timeFrame: 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
timeFrame: 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
timeFrame: 24 weeks
measure: Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)
timeFrame: 24 weeks
measure: Examine Potential Mediators of Intervention Effects on Patient-reported Outcomes
timeFrame: 24 weeks
measure: Examine Potential Moderators of Intervention Effects on Dyspnea
timeFrame: 24 weeks
measure: Health Service Utilization
timeFrame: 24 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Greer, PhD
role: PRINCIPAL_INVESTIGATOR
References: