Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

• ClinicalTrials.gov Identifier: NCT03089125
• Recruitment Status: Completed
• First Posted: March 24, 2017
• Last Update Posted: April 26, 2023
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Joseph A. Greer, Ph.D., Massachusetts General Hospital

Tracking Information

• First Submitted Date: March 20, 2017
• First Posted Date: March 24, 2017
• Last Update Posted Date: April 26, 2023
• Actual Study Start Date: May 15, 2017
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2017)

• Modified Medical Research Council Dyspnea Scale (MMRCDS) [ Time Frame: 8 weeks ]
  Compare the change between study groups in MMRCDS severity score from baseline to 8 weeks
• Cancer Dyspnoea Scale (CDS) [ Time Frame: 8 weeks ]
  Compare the change between study groups in the CDS score from baseline to 8 weeks

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 20, 2017)

• Functional Assessment of Cancer Treatment - Lung (FACT-L) [ Time Frame: 8 weeks ]
  Compare the change between study groups in FACT-L from baseline to 8 weeks
• Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 8 weeks ]
  Compare the change between study groups in anxiety and depression symptoms from baseline to 8 weeks
• Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) [ Time Frame: 8 weeks ]
  Compare the change between study groups in self-reported leisure time physical activity score from baseline to 8 weeks
• Activity Level (objective measures) [ Time Frame: 8 weeks ]
  Compare the change between study groups in the percentage of time spend immobile but awake on actigraphy

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 20, 2017)

• Modified Medical Research Council Dyspnea Scale (MMRCDS) [ Time Frame: 24 weeks ]
  Compare changes in the MMRCDS scores between study groups over the 24-week study period
• Cancer Dyspnoea Scale (CDS) [ Time Frame: 24 weeks ]
  Compare changes in the CDS scores between study groups over the 24-week study period
• Functional Assessment of Cancer Treatment - Lung (FACT-L) [ Time Frame: 24 weeks ]
  Compare changes in the FACT-L scores between study groups over the 24-week study period
• Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 24 weeks ]
  Compare changes in anxiety and depression symptoms between study groups over the 24-week study period
• Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire) [ Time Frame: 24 weeks ]
  Compare changes in self-reported leisure time physical activity score between study groups over the 24-week study period
• Examine potential mediators of intervention effects on patient-reported outcomes [ Time Frame: 24 weeks ]
  Examine the degree to which intervention effects on patient reported outcomes are mediated by improved mastery in managing breathlessness (as measured by the Chronic Respiratory Disease Questionnaire)
• Examine potential moderators of intervention effects on dyspnea [ Time Frame: 24 weeks ]
  Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors
• Health service utilization [ Time Frame: 24 weeks ]
  Examine differences between study groups in rates of emergency department and hospitalizations

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
• Official Title: Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Nurse administered dyspnea intervention

Masking: Single (Outcomes Assessor)
Masking Description:

Research staff collecting patient-reported measures will be blind to study assignment group

Primary Purpose: Supportive Care

• Condition: Lung Cancer

Intervention

• Behavioral: Dyspnea Intervention

  Dyspnea intervention will be administered over two sessions

  Patients will receive:

  • Psychoeducation
  • Relaxation training for reducing physiological stress
  • Behavioral techniques for managing acute breathlessness
• Other: Usual Care
  Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians

Study Arms

• Active Comparator: Usual Care
  Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians.
  Intervention: Other: Usual Care
• Experimental: Dyspnea Intervention

  Dyspnea intervention will be administered over two sessions

  Patients will receive:

  • Psychoeducation
  • Relaxation training for reducing physiological stress
  • Behavioral techniques for managing acute breathlessness
  Interventions:

  • Behavioral: Dyspnea Intervention
  • Other: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 25, 2023): 250
• Original Estimated Enrollment (submitted: March 20, 2017): 200
• Actual Study Completion Date: April 6, 2023
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03089125
• Other Study ID Numbers: 16-476
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Joseph A. Greer, Ph.D., Massachusetts General Hospital
• Original Responsible Party: Joseph A. Greer, Ph.D., Massachusetts General Hospital, Assistant Professor of Psychology
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joseph Greer, PhD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: April 2023