NCT05304793

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lung Non-Small Cell Carcinoma
• Lung Small Cell Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual management of dyspnea
BEHAVIORAL	Cognitive Behavior Therapy	Receive TAB treatment
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-07-16
• Completion: 2021-07-16
• First posted: 2022-03-31
• Last updated: 2024-10-31

Locations

1 site across 1 country: United States