Clinical trial NCT05304793: Testing a Cognitive Behavioral Model for Reducing Dyspnea in Patients With Lung Cancer
Official title: A Pilot Study to Test a Cognitive-Behavioral Model for Dyspnea in Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Non-Small Cell Carcinoma
Lung Small Cell Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in acceptability of Take a Breath (TAB)
timeFrame: Baseline up to 1 month post-treatment
measure: Change in tolerability of TAB
timeFrame: Baseline up to 1 month post-treatment
measure: Feasibility of TAB
timeFrame: Up to 1 month post-treatment
measure: Change in dyspnea severity using the American Thoracic Society Dyspnea Questionnaire
timeFrame: Baseline up to 1 month post-treatment
measure: Change in shortness of breath
timeFrame: Baseline up to 1 month post-treatment
Secondary outcomes:
measure: Mood disturbance
timeFrame: Up to 1 month post-treatment
measure: Catastrophic thoughts related to dyspnea
timeFrame: Up to 1 month post-treatment
measure: Physical activity using International Physical Activity Questionnaire (IPAQ)
timeFrame: Up to 1 month post-treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Barbara Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: