Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-03-06 @ 10:24 PM
Study NCT ID:
NCT06354959
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehab for Lung and Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009369', 'term': '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility- Recruitment', 'timeFrame': '2 years', 'description': 'Participant accrual as defined as the number of eligible participants who consent to participate'}, {'measure': 'Feasibility- Participant fidelity', 'timeFrame': '2 years', 'description': 'Participant adherence to prescribed exercise intervention'}, {'measure': 'Feasibility - Safety', 'timeFrame': '2 years', 'description': 'Adverse and serious adverse events'}, {'measure': 'Feasibility - Retention/Attrition', 'timeFrame': '2 years', 'description': 'Percentage of participants who complete the 12-week intervention'}, {'measure': 'Feasibility - Participant Experience', 'timeFrame': '2 years', 'description': 'Exit interview is used to assess factors influencing participant selection of intervention type/setting, adherence to and satisfaction with the health coaching program'}, {'measure': 'Feasibility- Attendance', 'timeFrame': '2 years', 'description': 'Attendance is calculated as the percentage of exercise sessions completed by the total number of available exercise sessions over the 8-10-week intervention.'}], 'secondaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E)', 'timeFrame': '8-10 week change', 'description': '44 item that measures multidimensional quality of life'}, {'measure': 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)', 'timeFrame': '8-10 week change', 'description': "a 13-item questionnaire that evaluates an individual's self-reported fatigue during their usual daily activities over the past week"}, {'measure': '5x chair stand', 'timeFrame': '8-10 week change', 'description': 'To test functional strengths, risk of falling and overall leg strength and endurance'}, {'measure': 'Stair climb test', 'timeFrame': '8-10 week change', 'description': 'To test functional strength, balance and agility'}, {'measure': 'Grip strength', 'timeFrame': '8-10 week change', 'description': 'To test overall body strength'}, {'measure': 'Resting Heart rate', 'timeFrame': '8-10 week change', 'description': 'Resting heart rate'}, {'measure': 'Resting blood pressure', 'timeFrame': '8-10 week change', 'description': 'resting systolic and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasm of Lung', 'Neoplasms', 'Exercise', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '40063931', 'type': 'DERIVED', 'citation': 'Langley JE, Sibley D, Chiekwe J, Keats MR, Snow S, Purcell J, Sollows S, Hill L, Watton D, Gaudry AE, Hashish I, Wallace A. Prehabilitation Program for Lung and Esophageal Cancers (Boosting Recovery and Activity Through Early Wellness): Protocol for a Nonrandomized Trial. JMIR Res Protoc. 2025 Mar 10;14:e60791. doi: 10.2196/60791.'}]}, 'descriptionModule': {'briefSummary': 'Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles.', 'detailedDescription': 'The purpose of this study is to explore the implementation, feasibility and effectiveness of a community-based prehabilitation health coaching program, including nutrition, smoking cessation, sleep hygiene and movement for individuals scheduled to undergo surgery for lung or esophageal cancer.. Participants will have the option to engage in a one-on-one prehabilitation health coaching program tailored to their needs, led by a Qualified Exercise Professional (QEP). The personalized prehabilitation plan will encompass 4-6 in-person or virtual meetings before surgery, including a structured movement plan, education on smoking cessation, sleep quality, stress reduction, mindfulness, and nutrition. Post-surgery, the QEP will provide support through counselling and scheduled sessions for a month after surgery and include one session while the patient is in hospital.\n\nThis research adopts a repeated measure, mixed-methods approach. Participants will undergo three clinical assessments at different stages: baseline, pre-surgery, and 4-6 weeks post-surgery. The findings from this study will guide future grant applications aimed at funding larger studies and the implementation of prehabilitation as part of standard of care in lung and esophageal cancer patients in Nova Scotia.\n\nCentral to the research endeavor is the driving question: "How can a community-based prehabilitation program be successfully implemented in the community, and can it lead to improved functional outcomes in patients undergoing surgery for lung or esophageal cancer?" This overarching question provides the study with its core focus and serves as a guiding force throughout the research process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with lung or esophageal cancer\n* Scheduled to receive surgical intervention in minimum 2-weeks\n* Surgeon approval\n* Able to read and write in English\n* \\>18 years of age\n\nExclusion Criteria:\n\n* Not able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06354959', 'briefTitle': 'Prehab for Lung and Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Prehab for Lung and Esophageal Cancer: Optimizing Well-being for Better Outcomes', 'orgStudyIdInfo': {'id': '1030020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Receive standard of care'}, {'type': 'EXPERIMENTAL', 'label': 'Prehab', 'description': 'Complete an 8-week community based prehab program.', 'interventionNames': ['Behavioral: Prehabilitation']}], 'interventions': [{'name': 'Prehabilitation', 'type': 'BEHAVIORAL', 'description': '8-week community based prehab program', 'armGroupLabels': ['Prehab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jodi Langley', 'role': 'CONTACT', 'email': 'jodi.langley@dal.ca', 'phone': '902-473-2035'}], 'facility': 'Victoria General Hospital', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dalhousie University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}