Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 3:11 PM
Study NCT ID:
NCT04826835
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline 6-minute walking distance from baseline to 3-month post-surgery', 'timeFrame': 'Baseline; 3-month post-surgery'}], 'secondaryOutcomes': [{'measure': 'Change from baseline 6-minute walking distance at post-intervention', 'timeFrame': 'Baseline; 2 weeks (post-intervention)'}, {'measure': 'Change from baseline 6-minute walking distance at 1-month post-surgery', 'timeFrame': 'Baseline; 1-months post-surgery'}, {'measure': 'Length of postoperative hospital stay', 'timeFrame': '1-month post-surgery'}, {'measure': 'Postoperative complication', 'timeFrame': '1-month post-surgery'}, {'measure': 'Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention', 'timeFrame': 'Baseline; 2 weeks (post-intervention)'}, {'measure': 'Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery', 'timeFrame': 'Baseline; 2 weeks (post-intervention); 1-month post-surgery'}, {'measure': 'Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 3-months post-surgery', 'timeFrame': 'Baseline; 3-month post-surgery'}, {'measure': 'Change from baseline international physical activity questionnaire (IPAQ) at post-intervention', 'timeFrame': 'Baseline; 2 weeks (post-intervention)'}, {'measure': 'Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery', 'timeFrame': 'Baseline; 1-month post-surgery'}, {'measure': 'Change from baseline international physical activity questionnaire (IPAQ) at 3-month post-surgery', 'timeFrame': 'Baseline; 3-month post-surgery'}, {'measure': 'Change from baseline daily step count measured by pedometer at post-intervention', 'timeFrame': 'Baseline; 2 weeks (post-intervention)'}, {'measure': 'Change from baseline daily step count measured by pedometer at 1-month post-surgery', 'timeFrame': 'Baseline; 1-month post-surgery'}, {'measure': 'Change from baseline daily step count measured by pedometer at 3-month post-surgery', 'timeFrame': 'Baseline; 3-month post-surgery'}, {'measure': 'Health-related quality of life for the cost-effectiveness analysis (EuroQol- 5 Dimension, EQ-5D-5L)', 'timeFrame': 'Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery'}, {'measure': 'Health-related quality of life for the cost-effectiveness analysis (EuroQol-Visual Analog Score, EQ-VAS)', 'timeFrame': 'Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery'}, {'measure': 'Physical activity self-efficacy (9-item Self-Efficacy for Exercise, SEE)', 'timeFrame': 'Baseline; 2 weeks (post-intervention); 1-month post-surgery; 3-month post-surgery'}, {'measure': 'Financial toxicity (COmprehensive Score for financial Toxicity, COST questionnaire)', 'timeFrame': 'Baseline; 3-month post-surgery'}, {'measure': 'Return to work (investigator-designed questionnaire)', 'timeFrame': '3-month post-surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation', 'Physical activity', 'Lung resection', 'Functional capacity'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation\n2. Patients scheduled to undergo lung resection surgery at least two weeks from recruitment\n3. Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment\n4. Patients with no evidence of recurrent or progressive disease\n5. Patients aged 45-80 years\n6. Patients able to communicate in Cantonese, Mandarin, or English\n7. Patients is absence of any cognitive impairment\n8. Patients with a score of 6 minutes walking test (6MWT) ≤ 500 meters at baseline. \\[rationale: a threshold value of 500 meters preoperative 6MWT predicts a higher risk of postoperative complications and prolonged LOS after lung resection\\]\n9. Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months\n\nExclusion Criteria:\n\n1. Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months\n2. Presence of another concurrent, actively treated malignancy\n3. Presence of chronic obstructive pulmonary disease\n4. Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living\n5. Not having a smart device to receive WhatsApp messages'}, 'identificationModule': {'nctId': 'NCT04826835', 'briefTitle': 'A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UW 19-214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation intervention', 'description': 'Participants in the intervention group will follow a 2-week prehabilitation program before lung resection.', 'interventionNames': ['Behavioral: Prehabilitation intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health education control', 'description': 'Participants in the control group will receive health education classes during 2 weeks before lung resection.', 'interventionNames': ['Behavioral: Health education control']}], 'interventions': [{'name': 'Prehabilitation intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will:\n\n* Receive four supervised exercise classes (twice per week for two weeks) one-to-one by an exercise specialist;\n* Practice six sessions of home-based exercise (three times per week for two weeks);\n* Practice unsupervised respiratory muscle training at home (twice daily for two weeks);\n* Receive usual care.', 'armGroupLabels': ['Prehabilitation intervention']}, {'name': 'Health education control', 'type': 'BEHAVIORAL', 'description': 'Participants will:\n\n* Receive four recorded health education talks (twice per week for two weeks)\n* Receive a brief health education booklet on dietary education for chronic lung conditions, preoperative preparation, and postoperative recovery\n* Receive usual care.', 'armGroupLabels': ['Health education control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Chia-chin Lin, PhD', 'role': 'CONTACT', 'email': 'cclin@hku.hk', 'phone': '39176614'}, {'name': 'Xinyi Xu, BSN', 'role': 'CONTACT', 'email': 'xuxinyi@connect.hku.hk', 'phone': '39176948'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Head', 'investigatorFullName': 'Professor Chia-Chin Lin', 'investigatorAffiliation': 'The University of Hong Kong'}}}}