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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05304793.
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorBarbara Andersen
