An interventional study of Best Practice and Cognitive Behavior Therapy in Lung Non-Small Cell Carcinoma and Lung Small Cell Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 46 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Cognitive Behavior Therapy · Other: Questionnaire Administration
Patients receive usual management of dyspnea from the treating physician.
Other: Best Practice · Other: Questionnaire Administration
Receive usual management of dyspnea
Also known as: standard of care, standard therapy
Receive TAB treatment
Also known as: CBT, cognitive therapy, CT
Ancillary studies
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).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 1 month post-treatment
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)
Time frame: 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.
Time frame: 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
Time frame: Up to 1 month post-treatment
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Ohio State University Comprehensive Cancer Center