Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

NCT03089125 | Completed Results DMC

• 1 other identifier: 16-476
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 2

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).

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Modified Medical Research Council Dyspnea Scale (mMRCDS)

  Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.

  8 weeks

• Cancer Dyspnoea Scale (CDS)

  Compare the difference between study groups in the Cancer Dyspnoea Scale scores at 8 weeks. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea.

  8 weeks

Secondary Outcomes (5)

• Functional Assessment of Cancer Therapy - Lung (FACT-L)

  8 weeks

• Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

  8 weeks

• Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

  8 weeks

• Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)

  8 weeks

• Activity Level (Objective Measure: Actigraphy)

  8 weeks

Other Outcomes (9)

• Modified Medical Research Council Dyspnea Scale (mMRCDS)

  24 weeks

• Cancer Dyspnoea Scale (CDS)

  24 weeks

• Functional Assessment of Cancer Therapy - Lung (FACT-L)

  24 weeks

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians.

Other: Usual Care

Dyspnea Intervention

EXPERIMENTAL

Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness

Behavioral: Dyspnea Intervention; Other: Usual Care

Interventions

Dyspnea Intervention BEHAVIORAL

Dyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness

Dyspnea Intervention

Usual Care OTHER

Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians

Dyspnea Intervention; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Nursing Research (NINR): collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Greer JA, Post KE, Chabria R, Aribindi S, Brennan N, Eche-Ugwu IJ, Halpenny B, Fox E, Lo S, Waldman LP, Pintro K, Rabideau DJ, Pirl WF, Cooley ME, Temel JS. Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer. J Clin Oncol. 2024 Oct 20;42(30):3570-3580. doi: 10.1200/JCO.24.00048. Epub 2024 Aug 1.

  PMID: 39088766 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Joseph A. Greer, Ph.D.
• Organization: Massachusetts General Hospital

jgreer2@mgh.harvard.edu

617-643-2143

Study Officials

• Joseph Greer, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff collecting patient-reported measures will be blind to study assignment group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: Nurse administered dyspnea intervention

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: May 15, 2017
• Primary Completion: October 26, 2022
• Study Completion: April 6, 2023
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)