Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05216302
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2022-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prehabilitation for Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)', 'timeFrame': 'Pre-Surgery (one week)', 'description': 'Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)'}, {'measure': 'Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)', 'timeFrame': 'One month post-surgery', 'description': 'Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)'}, {'measure': 'Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)', 'timeFrame': 'Three months post-surgery', 'description': 'Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)'}, {'measure': 'Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)', 'timeFrame': 'Six months post-surgery', 'description': 'Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)'}], 'secondaryOutcomes': [{'measure': 'Upper arm volume', 'timeFrame': 'Pre-Surgery (one week)', 'description': 'Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level'}, {'measure': 'Upper arm volume', 'timeFrame': 'One month post-surgery', 'description': 'Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level'}, {'measure': 'Upper arm volume', 'timeFrame': 'Three months post-surgery', 'description': 'Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level'}, {'measure': 'Upper arm volume', 'timeFrame': 'Six months post-surgery', 'description': 'Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level'}, {'measure': 'Range of Movement (ROM)', 'timeFrame': 'Pre-Surgery (one week)', 'description': 'Range of movement of the affected arm in three axes using a goniometer'}, {'measure': 'Range of Movement (ROM)', 'timeFrame': 'One month post-surgery', 'description': 'Range of movement of the affected arm in three axes using a goniometer'}, {'measure': 'Range of Movement (ROM)', 'timeFrame': 'Three months post-surgery', 'description': 'Range of movement of the affected arm in three axes using a goniometer'}, {'measure': 'Range of Movement (ROM)', 'timeFrame': 'Six months post-surgery', 'description': 'Range of movement of the affected arm in three axes using a goniometer'}, {'measure': 'Pain severity', 'timeFrame': 'Pre-Surgery (one week)', 'description': 'Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)'}, {'measure': 'Pain severity', 'timeFrame': 'One month post-surgery', 'description': 'Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)'}, {'measure': 'Pain severity', 'timeFrame': 'Three months post-surgery', 'description': 'Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)'}, {'measure': 'Pain severity', 'timeFrame': 'Six months post-surgery', 'description': 'Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Pre-Surgery (one week)', 'description': 'Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'One month post-surgery', 'description': 'Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Three months post-surgery', 'description': 'HHealth-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Six months post-surgery', 'description': 'Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Pre-Surgery (one week)', 'description': 'Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.'}, {'measure': 'Handgrip Strength', 'timeFrame': 'One month post-surgery', 'description': 'Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Three months post-surgery', 'description': 'Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Six months post-surgery', 'description': 'Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used.'}, {'measure': 'Functional capacity', 'timeFrame': 'Pre-surgery (one week)', 'description': 'Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.'}, {'measure': 'Functional capacity', 'timeFrame': 'One month post-surgery', 'description': 'Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.'}, {'measure': 'Functional capacity', 'timeFrame': 'Three months post-surgery', 'description': 'Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.'}, {'measure': 'Functional capacity', 'timeFrame': 'Six months post-surgery', 'description': 'Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.'}, {'measure': 'Adherence', 'timeFrame': 'Pre-Surgery (one week)', 'description': 'Adherence to the scheduled sessions will be registered in the Prehab group and will be reported as percentage of attended vs. scheduled.'}, {'measure': 'Physical Activity', 'timeFrame': 'Pre-surgery (one week)', 'description': 'Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.'}, {'measure': 'Physical Activity', 'timeFrame': 'One month post-surgery', 'description': 'Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.'}, {'measure': 'Physical Activity', 'timeFrame': 'Three months post-surgery', 'description': 'Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.'}, {'measure': 'Physical Activity', 'timeFrame': 'Six months post-surgery', 'description': 'Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'prehabilitation', 'exercise therapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28942905', 'type': 'BACKGROUND', 'citation': 'Santa Mina D, Brahmbhatt P, Lopez C, Baima J, Gillis C, Trachtenberg L, Silver JK. The Case for Prehabilitation Prior to Breast Cancer Treatment. PM R. 2017 Sep;9(9S2):S305-S316. doi: 10.1016/j.pmrj.2017.08.402.'}, {'pmid': '16818906', 'type': 'BACKGROUND', 'citation': 'McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.'}, {'pmid': '23756434', 'type': 'BACKGROUND', 'citation': 'Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.'}, {'pmid': '29683834', 'type': 'BACKGROUND', 'citation': 'Yang A, Sokolof J, Gulati A. The effect of preoperative exercise on upper extremity recovery following breast cancer surgery: a systematic review. Int J Rehabil Res. 2018 Sep;41(3):189-196. doi: 10.1097/MRR.0000000000000288.'}, {'type': 'BACKGROUND', 'citation': 'ILokapavani Y, Krishna SR, Madhavi K. nfluence of Pre - Operative Physical Therapy Education and Exercise on Post-operative Shoulder Range of Motion and Functional Activites in Subjects with Modified Radical Mastectomy. Int J Physiother 2014. DOI: 10.15621/ijphy/2014/v1i4/54556'}]}, 'descriptionModule': {'briefSummary': "Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery.\n\nTo this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm.\n\nThe study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy\n* Candidates to receive neoadjuvant chemotherapy\n* Not currently undergoing any other physical therapy therapies or treatments\n\nExclusion Criteria:\n\n* Cognitive impairment or inability to read Catalan or Spanish\n* Prior diagnosis of shoulder impairment or injury\n* Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program'}, 'identificationModule': {'nctId': 'NCT05216302', 'briefTitle': 'Prehabilitation for Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Pompeu Fabra'}, 'officialTitle': 'Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'IIBSP-PRO-2021-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Prehabilitation', 'description': 'Patients allocated to this arm will participate in a weekly group-based exercise intervention (nordic walking) and receive health education through a booklet, videos of the exercises and face-to-face sessions prior to each nordic walking session. Chemotherapy will continue as scheduled.', 'interventionNames': ['Behavioral: Group-based Nordic Walking Exercise Program']}], 'interventions': [{'name': 'Group-based Nordic Walking Exercise Program', 'type': 'BEHAVIORAL', 'description': 'An exercise intervention based on nordic walking and health education of one hour and 15 minutes per session. Each session includes 10 min of health education followed by 15 minutes of warm-up exercises, 30 minutes of nordic walking and finally 15 min to cool-down. The intervention is meant to last during two months (last round of chemotherapy and one month pre-surgery), twice weekly for approximately a total of 16 sessions.', 'armGroupLabels': ['Prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Raquel Sebio, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Health Sciences TecnoCampus. University Pompeu Fabra'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raquel Sebio', 'class': 'OTHER'}, 'collaborators': [{'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Raquel Sebio', 'investigatorAffiliation': 'Universitat Pompeu Fabra'}}}}