Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-29 @ 5:49 AM
Study NCT ID:
NCT05059132
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pilot, parallel randomized study of an exercise + behavioral support intervention to reduce dyspnea and improve walking behavior among lung cancer survivors following curative intent therapy. Forty participants will be randomized 1:1 to the intervention or control arm, with assessments of feasibility, acceptability, safety, and patient-centered outcomes. The intervention period is 12 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in change in accelerometry-measured physical activity between baseline and week 12', 'timeFrame': 'Baseline, mid study (week 6), and end of study (week 12).', 'description': 'Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd).'}], 'secondaryOutcomes': [{'measure': 'Difference in change in functional capacity between baseline and week 12', 'timeFrame': 'Baseline, mid study (week 6), and end of study (week 12)', 'description': 'Functional capacity will be measured using the mobile six-minute walk test.'}, {'measure': 'Difference in change in self-reported physical activity between baseline and week 12', 'timeFrame': 'Baseline, mid study (week 6), and end of study (week 12)', 'description': 'Self-reported physical activity will be measured using the International Physical Activity Questionnaire - Short Form'}, {'measure': 'Difference in change in control of dyspnea between baseline and week 12', 'timeFrame': 'Baseline, mid study (week 6), and end of study (week 12)', 'description': 'Dyspnea control will be measured using the the University of California, San Diego Shortness of Breath Questionnaire.'}, {'measure': 'Difference in change in anxiety symptoms between baseline and week 12', 'timeFrame': 'Baseline, mid study (week 6), and end of study (week 12)', 'description': 'Anxiety symptoms will be measured using the General Anxiety Disorder-7'}, {'measure': 'Difference in change in sleep quality between baseline and week 12', 'timeFrame': 'Baseline, mid study (week 6), and end of study (week 12)', 'description': 'Sleep quality will be measured using the Pittsburgh Sleep Quality Index'}, {'measure': 'Difference in change in quality of life between baseline and week 12', 'timeFrame': 'Baseline, mid study (week 6), and end of study (week 12)', 'description': "Quality of life will be measured using the St. George's Respiratory Questionnaire"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilot study', 'Tele-rehabilitation', 'Remote rehabilitation', 'Exercise therapy', 'Aerobic exercise', 'Physical activity'], 'conditions': ['Lung Neoplasm']}, 'referencesModule': {'references': [{'pmid': '37656252', 'type': 'RESULT', 'citation': 'Ha DM, Comer A, Dollar B, Bedoy R, Ford M, Gozansky WS, Zeng C, Arch JJ, Leach HJ, Malhotra A, Prochazka AV, Keith RL, Boxer RS. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy.\n\nThe specific aims and hypotheses are:\n\nSpecific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40).\n\nHypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program.\n\nHypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events.\n\nSpecific Aim 2: Explore the effects of the tele-rehabilitation program (N=40).\n\nHypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including:\n\n1. accelerometry-measured physical activity (primary outcome); and\n2. functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* history of stage I-IIIA lung cancer;\n* completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months;\n* access to a mobile phone or personal computer with internet access;\n* willingness to wear activity trackers\n\nExclusion Criteria:\n\n* dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent;\n* acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months;\n* spontaneous pneumothorax in past 12 months;\n* Parkinson's disease;\n* multiple sclerosis;\n* amyotrophic lateral sclerosis;\n* additional movement/gait disorders that may be identified by chart review"}, 'identificationModule': {'nctId': 'NCT05059132', 'briefTitle': 'Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer', 'orgStudyIdInfo': {'id': 'LCD-820773'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tele-rehabilitation', 'description': 'Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program.', 'interventionNames': ['Behavioral: Tele-rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education only', 'description': 'Participants in the education arm will receive educational materials only, delivered through telecommunication messages.', 'interventionNames': ['Other: Education only']}], 'interventions': [{'name': 'Tele-rehabilitation', 'type': 'BEHAVIORAL', 'description': 'The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.', 'armGroupLabels': ['Tele-rehabilitation']}, {'name': 'Education only', 'type': 'OTHER', 'description': 'The education only arm will receive information on the importance of general exercise following lung cancer treatment.', 'armGroupLabels': ['Education only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Lung Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}