Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-14 @ 5:38 AM
Study NCT ID:
NCT04248959
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Global health score', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Primary exploratory outcome: European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30'}, {'measure': 'Postoperative complications', 'timeFrame': '1 month postoperative (T2)', 'description': 'Postoperative complication severity and frequency defined according to the Common Terminology Criteria for Adverse Events.'}, {'measure': 'Length of stay', 'timeFrame': '1 month postoperative (T2)', 'description': 'Average postoperative hospitalization period'}, {'measure': 'Functional capacity', 'timeFrame': 'Baseline (T0), preoperative (T1)', 'description': 'Total distance traveled during six-minute walk test'}, {'measure': 'Physical activity behavior (subjective)', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Godin Leisure-time Exercise Questionnaire'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'EQ-5D; All 5 items are rated on a 1 to 3 scale with higher numbers reflecting worse outcomes.'}, {'measure': 'Symptom burden', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Edmonton Symptom Assessment Scale (ESAS); All 10 items are rated on a 0 to 10 scale with higher numbers reflecting worse outcomes.'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Hospital Anxiety and Depression Scale (HADS); All 14 items are rated on a 0 to 3 scale with higher numbers reflecting worse outcomes.'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F); All 13 items are rated on a 0 to 4 scale with higher numbers reflecting worse outcomes.'}, {'measure': 'Impact on work', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Work Limitations Questionnaire'}, {'measure': 'Social support', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Medical Outcomes Study Social Support Scale (SF-20); All item scores transformed into 0 to 100 scales with higher scores reflecting better outcomes.'}, {'measure': 'Relationships', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Experiences in Close Relationships scale (ECR); All 36 items rated on a 1 to 7 scale with higher scores reflecting worse outcomes.'}, {'measure': 'Extremity function', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Toronto Extremity Salvage Score (upper or lower)'}, {'measure': 'Disease burden', 'timeFrame': 'Baseline (T0), preoperative (T1), 1 month postoperative (T2)', 'description': 'Musculoskeletal Tumor Society score'}], 'primaryOutcomes': [{'measure': 'Patient recruitment rate (feasibility target: >=50% of eligible participants)', 'timeFrame': 'Initiation through end of study recruitment at 12 months', 'description': 'Defined as the percent of consenting patients based on the total number of otherwise eligible patients (OEP; patients meeting all study eligibility criteria) approached'}, {'measure': 'Testing- and intervention-related serious adverse events (feasibility target: none)', 'timeFrame': 'Initiation through end of pre-operative testing', 'description': 'Defined as the number and frequency of testing- and intervention-related serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events'}, {'measure': 'Patient exercise adherence (feasibility target: >=70% of prescribed)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as relative dose intensity as the percent of total dose of exercise performed relative to the total planned dose prescribed and quantified according to metabolic equivalents'}], 'secondaryOutcomes': [{'measure': 'Patient identification rate (feasibility target: >=50% of OEP)', 'timeFrame': 'Initiation through end of study recruitmentat 12 months', 'description': 'Defined as the average number of OEP identified each month'}, {'measure': 'Baseline assessment rate (feasibility target: >=90% of consenting participants)', 'timeFrame': 'Initiation through end of study recruitment at 12 months', 'description': 'Defined as the percent of consenting patients who successfully complete baseline assessments based on the total number of consenting patients'}, {'measure': 'Intervention window (feasibility target: >=21 days)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the average elapsed time (in days) between diagnosis and extremity sarcoma surgery'}, {'measure': 'Testing- and intervention-related non-serious adverse events (feasibility target: <20% of sessions)', 'timeFrame': 'Initiation through end of pre-operative testing', 'description': 'Defined as the number and frequency of testing- and intervention-related non-serious adverse events (nSAEs) according to the Common Terminology Criteria for Adverse Events'}, {'measure': 'Testing performance (feasibility target: >=95% completion of tests)', 'timeFrame': 'Initiation through end of pre-operative testing', 'description': 'Defined as percent completion physical testing at baseline and follow-up'}, {'measure': 'Testing modality adaptations (descriptive)', 'timeFrame': 'Initiation through end of pre-operative testing', 'description': 'Defined as the percent of all tests which are adapted for functional or safety reasons'}, {'measure': 'Training modality adaptations (descriptive)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of all exercise sessions which are adapted for functional or safety reasons'}, {'measure': 'Permanent treatment discontinuation (feasibility target: <=15% of participants)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of patients who discontinue intervention participation prior to the planned end of the intervention period'}, {'measure': 'Treatment interruption (feasibility target: <=15% of participants)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of patients who miss ≥3 consecutive sessions within the intervention period'}, {'measure': 'Dose modification (feasibility target: <=25% of participants)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of exercise sessions requiring a dose reduction during training (i.e., intensity or duration) relative to the total number of sessions completed. Total number of exercise sessions with a reduction in intensity or a reduction in duration will be combined into the numerator when calculating the percentage of affected sessions.'}, {'measure': 'Early session termination (feasibility target: <=25% of participants)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of exercise sessions requiring unplanned early termination'}, {'measure': 'Pretreatment intensity modification (feasibility target: <=25% of participants)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of sessions which required pre-exercise modification of the target exercise intensity due to a pre-exercise screening indication (e.g., fatigue, pain)'}, {'measure': 'Physical prehabilitation compliance (feasibility target: >=70% of prescribed)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of exercise sessions completed based on the total number of sessions prescribed'}, {'measure': 'Mindfulness prehabilitation compliance (feasibility target: >=70% of prescribed)', 'timeFrame': 'Initiation through end of study intervention period', 'description': 'Defined as the percent of psychological sessions completed based on the total number of sessions prescribed'}, {'measure': 'Attrition (feasibility target: <=20% loss to follow-up)', 'timeFrame': 'Study initiation through end of 1 month postoperative (T2)', 'description': 'Defined as the percent loss to follow-up (not completing follow-up assessments), individually and overall'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative Care', 'Exercise Therapy', 'Prehabilitation', 'Extremity Sarcoma', 'Adolescents and Young Adults'], 'conditions': ['Sarcoma,Soft Tissue', 'Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the feasibility of a multimodal prehabilitation intervention intended to optimize postoperative recovery in adolescents and young adults (AYAs) diagnosed with soft tissue and bone-based sarcomas of the upper and lower extremities (extremity sarcomas; ES).', 'detailedDescription': 'Objectives:\n\nThis objective of this study was to investigate the feasibility of multimodal prehabilitation for adolescents and young adults (AYAs) diagnosed with soft tissue and bone-based sarcomas of the upper and lower extremities (extremity sarcomas; ES) and explore its effects on measurements of health-related quality of life, physical function, length of hospital stays, and post-operative complications. Specific aims of the study included:\n\n* To determine the feasibility of conducting a larger phase II investigation of HIIT-based multimodal prehabilitation according to three primary criteria, including (i) recruiting \\>=50% of otherwise eligible patients (OEP; i.e., patients meeting all eligibility criteria), (ii) no patient experiences a testing-related or an intervention-related serious adverse event (SAE), and (iii) patients achieve an exercise intervention adherence rate of \\>=70%.\n* To further determine the feasibility of conducting a larger phase II investigation of HIIT-based multimodal prehabilitation according to the secondary feasibility criteria.\n* To explore the preliminary effects of prehabilitation on measures of short-term perioperative outcomes including health-related quality of life, physical function, length of hospital stays, and post-operative complications.\n\nMethods:\n\nA single-arm, proof-of-concept trial design was informed by the ORBIT model of behavioural treatment development. Mixed methods were employed to obtain relevant context for investigating the feasibility of multimodal prehabilitation in newly diagnosed AYAs with ES within the circumstances of the COVID-19 pandemic.\n\nParticipants underwent virtual multimodal prehabilitation before undergoing major extremity sarcoma surgery. This program encompassed personalized exercise, nutrition, and stress management support delivered by a registered kinesiologist, registered dietitian, and clinical psychologist, respectively. The interventions were designed to enhance physical and psychological resilience to stress, with the objective of improving recovery outcomes and mitigating the risk of adverse events.\n\nFeasibility (e.g., recruitment, safety, tolerability), physical function, and patient-reported outcomes were measured at baseline (T0), immediately preoperatively (T1), and one month postoperatively (T2).\n\nFeasibility data and field notes were collected by the research coordinators (during recruitment and postoperative follow-up) and by the study lead / research assistants during the intervention period. A postoperative interview explored experiences with prehabilitation into explore the feasibility and practical considerations of virtual prehabilitation for adolescents and young adults with extremity sarcomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years and \\<40 years of age at diagnosis\n* Fluent in English\n* Able to comply with study and follow-up procedures contained within the consent form\n* Pathologically or radiologically confirmed diagnosis of a soft-tissue or osteosarcoma of the upper or lower extremities\n* Soft-tissue or osteosarcoma must be considered operable\n* Patients of all weight bearing states will be eligible\n* Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator\n* \\>14 days between time of randomization and time of expected surgery\n* Patient written, informed consent obtained according to ICH GCP guidelines and local regulations\n* Medical clearance to participate in the study from either the primary treating surgeon (JW, PF) or oncologist (AG)\n\nExclusion Criteria:\n\n* Planned resection of bony pelvis or major lower extremity neurovascular structures\n* Significant comorbidity including any of the following:\n\n * Canadian Cardiovascular Society class III/IV coronary disease\n * New York Heart Association class III/IV congestive heart failure\n * Neurologic or musculoskeletal disorder prohibiting exercise\n * Major neuropsychiatric disorder\n* High-risk or presence of pathological fracture'}, 'identificationModule': {'nctId': 'NCT04248959', 'acronym': 'PICaSO-ES', 'briefTitle': 'Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial', 'orgStudyIdInfo': {'id': '18-5901'}, 'secondaryIdInfos': [{'id': '18-0226', 'type': 'OTHER', 'domain': 'Toronto Academic Health Sciences Network'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal Prehabilitation', 'description': 'Facility and home-based multimodal prehabilitation (aerobic exercise training, resistance exercise training, nutrition support, stress management and mindfulness training)', 'interventionNames': ['Behavioral: Multimodal prehabilitation']}], 'interventions': [{'name': 'Multimodal prehabilitation', 'type': 'BEHAVIORAL', 'description': 'Multimodal Prehabilitation\n\n* Aerobic exercise\n\n * Home-based, high-intensity interval training (HIIT), 2 days/week\n * Home-based, moderate-intensity continuous training (MICT), 2-3 days/week\n* Resistance exercise\n\n * Home-based, moderate-intensity resistance training, 2-3 d/wk, all major muscle groups (working around tumour-related deficits), 8-10 exercises, 12-15 repetitions, resistance bands and body weight based\n* Nutrition\n\n * Protein intake 1.2-1.5 g/kg body weight/day in compliance with European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines\n* Stress management\n\n * Daily mindfulness practice, 20 min/session, guided by audio file created at Mount Sinai Hospital', 'armGroupLabels': ['Multimodal Prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Daniel R Santa Mina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto; University Health Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'MOUNT SINAI HOSPITAL', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician Investigator', 'investigatorFullName': 'Daniel Santa Mina', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}