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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-07-16

Brief Summary

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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.

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Detailed Description

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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

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Lung Non-Small Cell Carcinoma Lung Small Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (TAB)

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.

Group Type EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

Receive TAB treatment

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (usual care)

Patients receive usual management of dyspnea from the treating physician.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual management of dyspnea

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual management of dyspnea

Intervention Type OTHER

Cognitive Behavior Therapy

Receive TAB treatment

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy CBT cognitive therapy CT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No