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

Lung Non-Small Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304793
• Other study ID #: OSU-20089
• Secondary ID: NCI-2020-08108
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 16, 2021

Study information

• Verified date: October 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Small Cell
• Dyspnea
• Lung Non-Small Cell Carcinoma
• Lung Small Cell Carcinoma
• Small Cell Lung Carcinoma

Intervention

Other:
• Best Practice
Receive usual management of dyspnea

Behavioral:
• Cognitive Behavior Therapy
Receive TAB treatment

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

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