Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT05304793
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing a Cognitive Behavioral Model for Reducing Dyspnea in Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-01', 'size': 281973, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-03T08:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in acceptability of Take a Breath (TAB)', 'timeFrame': 'Baseline up to 1 month post-treatment', 'description': '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).'}, {'measure': 'Change in tolerability of TAB', 'timeFrame': 'Baseline up to 1 month post-treatment', 'description': '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).'}, {'measure': 'Feasibility of TAB', 'timeFrame': 'Up to 1 month post-treatment', 'description': 'Based on patient enrollment (% of eligible patients enrolled to the study) and treatment adherence (% of patients retained in the study)'}, {'measure': 'Change in dyspnea severity using the American Thoracic Society Dyspnea Questionnaire', 'timeFrame': 'Baseline up to 1 month post-treatment', 'description': '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.'}, {'measure': 'Change in shortness of breath', 'timeFrame': 'Baseline up to 1 month post-treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mood disturbance', 'timeFrame': 'Up to 1 month post-treatment', 'description': 'The POMS-SF is a 37-item self-report measure of psychological distress. Patients are asked to indicate the degree to which each item, a moodrelated adjective (e.g., tense), describes themselves on a 5-point Likert scale (0=not at all to 4=extremely). The POMS-SF provides an overall Total Mood Disturbance score as well as scores for each of the six subscales (tension-anxiety, depression, anger-hostility, vigor-activity, fatigue, and confusion-bewilderment)'}, {'measure': 'Catastrophic thoughts related to dyspnea', 'timeFrame': 'Up to 1 month post-treatment', 'description': 'e 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.'}, {'measure': 'Physical activity using International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'Up to 1 month post-treatment', 'description': 'The IPAQ is a 7-item measure of physical activity conducted over the previous week. Participants are asked to list the amount of time they engaged in each of the listed activities (e.g. During the last 7 days, how much time did you spend sitting on a week day?). Extensive reliability and validity testing undertaken across 12 countries indicates that this measure demonstrates strong psychometric properties'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Non-Small Cell Carcinoma', 'Lung Small Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40772929', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. 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).\n\nSECONDARY OBJECTIVES:\n\nI. To provide preliminary data on the effectiveness of TAB on dyspnea and related distress and impairment.\n\nII. To test cognitive-behavioral variables (physical symptoms, thoughts, behaviors, and emotions) as predictors of dyspnea severity and anxiety sensitivity as a moderator.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM 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.\n\nARM II: Patients receive usual management of dyspnea from the treating physician.\n\nAfter completion of study, patients are followed up at 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)\n* Currently experiencing dyspnea as defined by a score \\>= 1 on the American Thoracic Society (ATS) Dyspnea Questionnaire within 3 weeks of enrollment\n* Seeking medical oncology care and treatment at the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic\n* Ability to understand and willingness to sign an informed consent document\n\nExclusion Criteria:\n\n* 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\n* Life expectancy \\< 2 months\n* History of surgery for lung cancer"}, 'identificationModule': {'nctId': 'NCT05304793', 'briefTitle': 'Testing a Cognitive Behavioral Model for Reducing Dyspnea in Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A Pilot Study to Test a Cognitive-Behavioral Model for Dyspnea in Patients With Lung Cancer', 'orgStudyIdInfo': {'id': 'OSU-20089'}, 'secondaryIdInfos': [{'id': 'NCI-2020-08108', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (TAB)', '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.', 'interventionNames': ['Behavioral: Cognitive Behavior Therapy', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (usual care)', 'description': 'Patients receive usual management of dyspnea from the treating physician.', 'interventionNames': ['Other: Best Practice', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive usual management of dyspnea', 'armGroupLabels': ['Arm II (usual care)']}, {'name': 'Cognitive Behavior Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT', 'cognitive therapy', 'CT'], 'description': 'Receive TAB treatment', 'armGroupLabels': ['Arm I (TAB)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (TAB)', 'Arm II (usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Barbara Andersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barbara Andersen', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}