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Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dyspnea Intervention
Usual Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of stage IV NSCLC or extensive stage SCLC
  • 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

Sites / Locations

  • Massachusetts General Hospital
  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Dyspnea Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Assessment of Cancer Treatment - Lung (FACT-L)
Compare the change between study groups in FACT-L from baseline to 8 weeks
Hospital Anxiety and Depression Scale (HADS)
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)
Compare the change between study groups in self-reported leisure time physical activity score from baseline to 8 weeks
Activity Level (objective measures)
Compare the change between study groups in the percentage of time spend immobile but awake on actigraphy

Full Information

First Posted
March 20, 2017
Last Updated
April 25, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03089125
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Nurse administered dyspnea intervention
Masking
Outcomes Assessor
Masking Description
Research staff collecting patient-reported measures will be blind to study assignment group
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians.
Arm Title
Dyspnea Intervention
Arm Type
Experimental
Arm Description
Dyspnea intervention will be administered over two sessions Patients will receive: Psychoeducation Relaxation training for reducing physiological stress Behavioral techniques for managing acute breathlessness
Intervention Type
Behavioral
Intervention Name(s)
Dyspnea Intervention
Intervention Description
Dyspnea intervention will be administered over two sessions Patients will receive: Psychoeducation Relaxation training for reducing physiological stress Behavioral techniques for managing acute breathlessness
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians
Primary Outcome Measure Information:
Title
Modified Medical Research Council Dyspnea Scale (MMRCDS)
Description
Compare the change between study groups in MMRCDS severity score from baseline to 8 weeks
Time Frame
8 weeks
Title
Cancer Dyspnoea Scale (CDS)
Description
Compare the change between study groups in the CDS score from baseline to 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Treatment - Lung (FACT-L)
Description
Compare the change between study groups in FACT-L from baseline to 8 weeks
Time Frame
8 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Compare the change between study groups in anxiety and depression symptoms from baseline to 8 weeks
Time Frame
8 weeks
Title
Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)
Description
Compare the change between study groups in self-reported leisure time physical activity score from baseline to 8 weeks
Time Frame
8 weeks
Title
Activity Level (objective measures)
Description
Compare the change between study groups in the percentage of time spend immobile but awake on actigraphy
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Modified Medical Research Council Dyspnea Scale (MMRCDS)
Description
Compare changes in the MMRCDS scores between study groups over the 24-week study period
Time Frame
24 weeks
Title
Cancer Dyspnoea Scale (CDS)
Description
Compare changes in the CDS scores between study groups over the 24-week study period
Time Frame
24 weeks
Title
Functional Assessment of Cancer Treatment - Lung (FACT-L)
Description
Compare changes in the FACT-L scores between study groups over the 24-week study period
Time Frame
24 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Compare changes in anxiety and depression symptoms between study groups over the 24-week study period
Time Frame
24 weeks
Title
Activity Level (self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)
Description
Compare changes in self-reported leisure time physical activity score between study groups over the 24-week study period
Time Frame
24 weeks
Title
Examine potential mediators of intervention effects on patient-reported outcomes
Description
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)
Time Frame
24 weeks
Title
Examine potential moderators of intervention effects on dyspnea
Description
Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors
Time Frame
24 weeks
Title
Health service utilization
Description
Examine differences between study groups in rates of emergency department and hospitalizations
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Greer, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

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