Testing a Cognitive Behavioral Model for Reducing Dyspnea in Patients With Lung Cancer

A Pilot Study to Test a Cognitive-Behavioral Model for Dyspnea in Patients With Lung Cancer

This trial studies the effect of a form of cognitive-behavioral therapy, Take a Breath, on reducing the intensity and frequency of dyspnea (difficulty breathing) in patients with lung cancer. Take a Breath consists of individual therapy sessions that educate patients on dyspnea and provides coping strategies.

Study Overview

• Status: Completed
• Conditions: Lung Non-Small Cell Carcinoma; Lung Small Cell Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Cognitive Behavior Therapy; Other: Best Practice

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the acceptability (based on patient satisfaction), tolerability (based on rate of symptom exacerbation from pre- to post-treatment), and feasibility (based on number of patients agreeing to be participate, adherence rate, and retention rate of treatment) of Take a Breath (TAB), a skills-based cognitive-behavioral treatment lasting 4 weekly hour-long sessions targeting dyspnea and related distress and impairment, in adults with lung cancer (N=40).

SECONDARY OBJECTIVES:

I. To provide preliminary data on the effectiveness of TAB on dyspnea and related distress and impairment.

II. To test cognitive-behavioral variables (physical symptoms, thoughts, behaviors, and emotions) as predictors of dyspnea severity and anxiety sensitivity as a moderator.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in 4 weekly TAB in-person or video conference sessions over 1 hour each that provide them with skills to cope with their dyspnea. Patients also receive treatment handouts, a compact disk (CD) with an audio file with instructions for progressive muscle relaxation, and a pulse oximeter. Patients may receive additional support calls over 10-15 minutes from the TAB provider within 1 week following each session.

ARM II: Patients receive usual management of dyspnea from the treating physician.

After completion of study, patients are followed up at 1 month.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
• Currently experiencing dyspnea as defined by a score >= 1 on the American Thoracic Society (ATS) Dyspnea Questionnaire within 3 weeks of enrollment
• Seeking medical oncology care and treatment at the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
• Ability to understand and willingness to sign an informed consent document

Exclusion Criteria:

• Presence of other serious comorbidities that would interfere with patients' study participation (e.g., serious mental illness, heart disease) as determined by the treating oncologist
• Life expectancy < 2 months
• History of surgery for lung cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (TAB); Patients participate in 4 weekly TAB in-person or video conference sessions over 1 hour each that provide them with skills to cope with their dyspnea. Patients also receive treatment handouts, a CD with an audio file with instructions for progressive muscle relaxation, and a pulse oximeter. Patients may receive additional support calls over 10-15 minutes from the TAB provider within 1 week following each session.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Cognitive Behavior Therapy; Receive TAB treatment; Other Names: CT; CBT; cognitive therapy
Active Comparator: Arm II (usual care); Patients receive usual management of dyspnea from the treating physician.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual management of dyspnea; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in acceptability of Take a Breath (TAB)	Will be based on patient satisfaction scores using the Client Satisfaction Questionnaire, and will be determined to be acceptable if patient satisfaction scores at least "moderately" satisfied. To determine change over time in TAB, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), and time (random). To determine a differential rate of change in outcomes between TAB and treatment as usual (TAU), each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), time (random), condition (fixed) and the fixed interaction between time and condition (time x condition).	Baseline up to 1 month post-treatment
Change in tolerability of TAB	Will be based on the change in dyspnea symptoms from pre- to post-treatment, and determined to be tolerable if there is not a significant increase in dyspnea symptoms at post-treatment. To determine change over time in TAB, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), and time (random). To determine a differential rate of change in outcomes between TAB and TAU, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), time (random), condition (fixed) and the fixed interaction between time and condition (time x condition).	Baseline up to 1 month post-treatment
Feasibility of TAB	Based on patient enrollment (% of eligible patients enrolled to the study) and treatment adherence (% of patients retained in the study)	Up to 1 month post-treatment
Change in dyspnea severity using the American Thoracic Society Dyspnea Questionnaire	Will be assessed per the American Thoracic Society (ATS) Dyspnea Questionnaire. The ATS Dyspnea Questionnaire is a 5-item self-report measure of dyspnea with higher scores indicating greater severity. This scale was developed for epidemiological research and is a common, brief clinical measure of dyspnea. Items are summed with scores ranging from 0-5. Responses of 0 indicate no dyspnea while responses ≥1 indicate experiences of dyspnea.	Baseline up to 1 month post-treatment
Change in shortness of breath	Will be assessed per the Shortness of Breath Questionnaire. The BCS is a 13-item self-report measure of catastrophic thoughts regarding breathlessness[59]. Patients rate "the degree to which you have these thoughts and feelings when you are experiencing breathlessness" (e.g., "I feel I can't go on"). Each item is rated on a 5-point Likert scale (0=not at all to 4=all the time). The BCS is a reliable measure and was originally validated in patients with severe COPD.	Baseline up to 1 month post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood disturbance	The POMS-SF is a 37-item self-report measure of psychological distress. Patients are asked to indicate the degree to which each item, a moodrelated adjective (e.g., tense), describes themselves on a 5-point Likert scale (0=not at all to 4=extremely). The POMS-SF provides an overall Total Mood Disturbance score as well as scores for each of the six subscales (tension-anxiety, depression, anger-hostility, vigor-activity, fatigue, and confusion-bewilderment)	Up to 1 month post-treatment
Catastrophic thoughts related to dyspnea	e BCS is a 13-item self-report measure of catastrophic thoughts regarding breathlessness[59]. Patients rate "the degree to which you have these thoughts and feelings when you are experiencing breathlessness" (e.g., "I feel I can't go on"). Each item is rated on a 5-point Likert scale (0=not at all to 4=all the time). The BCS is a reliable measure and was originally validated in patients with severe COPD.	Up to 1 month post-treatment
Physical activity using International Physical Activity Questionnaire (IPAQ)	The IPAQ is a 7-item measure of physical activity conducted over the previous week. Participants are asked to list the amount of time they engaged in each of the listed activities (e.g. During the last 7 days, how much time did you spend sitting on a week day?). Extensive reliability and validity testing undertaken across 12 countries indicates that this measure demonstrates strong psychometric properties	Up to 1 month post-treatment

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Barbara Andersen, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): July 16, 2021

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Respiration Disorders; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Signs and Symptoms, Respiratory; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Dyspnea
• Other Study ID Numbers: OSU-20089; NCI-2020-08108 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No