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

The Ohio State University

Status: Completed

Conditions: Lung Small Cell Carcinoma; Lung Non-Small Cell Carcinoma

Treatments: Behavioral: Cognitive Behavior Therapy; Other: Questionnaire Administration; Other: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT05304793

OSU-20089

NCI-2020-08108 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Arm I (TAB)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Behavioral: Cognitive Behavior Therapy

Arm II (usual care)

Active Comparator group

Description:

Patients receive usual management of dyspnea from the treating physician.

Treatment:

Other: Best Practice

Other: Questionnaire Administration