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

NCT05304793 | Completed DMC

• 2 other identifiers: OSU-20089NCI-2020-08108
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Non-Small Cell Carcinoma; Lung Small Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• Change in acceptability of Take a Breath (TAB)

  Will be based on patient satisfaction scores using the Client Satisfaction Questionnaire, and will be determined to be acceptable if patient satisfaction scores at least "moderately" satisfied. To determine change over time in TAB, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), and time (random). To determine a differential rate of change in outcomes between TAB and treatment as usual (TAU), each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), time (random), condition (fixed) and the fixed interaction between time and condition (time x condition).

  Baseline up to 1 month post-treatment

• Change in tolerability of TAB

  Will be based on the change in dyspnea symptoms from pre- to post-treatment, and determined to be tolerable if there is not a significant increase in dyspnea symptoms at post-treatment. To determine change over time in TAB, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), and time (random). To determine a differential rate of change in outcomes between TAB and TAU, each analysis will include: covariates selected based on significant spearman correlation with outcomes, time (fixed), time (random), condition (fixed) and the fixed interaction between time and condition (time x condition).

  Baseline up to 1 month post-treatment

• Feasibility of TAB

  Based on patient enrollment (% of eligible patients enrolled to the study) and treatment adherence (% of patients retained in the study)

  Up to 1 month post-treatment

• Change in dyspnea severity using the American Thoracic Society Dyspnea Questionnaire

  Will be assessed per the American Thoracic Society (ATS) Dyspnea Questionnaire. The ATS Dyspnea Questionnaire is a 5-item self-report measure of dyspnea with higher scores indicating greater severity. This scale was developed for epidemiological research and is a common, brief clinical measure of dyspnea. Items are summed with scores ranging from 0-5. Responses of 0 indicate no dyspnea while responses ≥1 indicate experiences of dyspnea.

  Baseline up to 1 month post-treatment

• Change in shortness of breath

  Will be assessed per the Shortness of Breath Questionnaire. The BCS is a 13-item self-report measure of catastrophic thoughts regarding breathlessness\[59\]. Patients rate "the degree to which you have these thoughts and feelings when you are experiencing breathlessness" (e.g., "I feel I can't go on"). Each item is rated on a 5-point Likert scale (0=not at all to 4=all the time). The BCS is a reliable measure and was originally validated in patients with severe COPD.

  Baseline up to 1 month post-treatment

Secondary Outcomes (3)

• Mood disturbance

  Up to 1 month post-treatment

• Catastrophic thoughts related to dyspnea

  Up to 1 month post-treatment

• Physical activity using International Physical Activity Questionnaire (IPAQ)

  Up to 1 month post-treatment

Study Arms (2)

Arm I (TAB)

EXPERIMENTAL

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.

Behavioral: Cognitive Behavior Therapy; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

Patients receive usual management of dyspnea from the treating physician.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual management of dyspnea

Also known as: standard of care, standard therapy

Arm II (usual care)

Cognitive Behavior Therapy BEHAVIORAL

Receive TAB treatment

Also known as: CBT, cognitive therapy, CT

Arm I (TAB)

Questionnaire Administration OTHER

Ancillary studies

Arm I (TAB); Arm II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Lo SB, Arrato NA, Presley CJ, McGinty HL, Otto MW, Andersen BL. Cognitive-Behavioral Treatment for Breathlessness in Lung Cancer: A Randomized Controlled Trial. Ann Am Thorac Soc. 2025 Oct;22(10):1579-1591. doi: 10.1513/AnnalsATS.202406-580OC.

  PMID: 40772929 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Practice Guidelines as Topic; Standard of Care; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Barbara Andersen, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 31, 2022
• Study Start: July 1, 2020
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)