Clinical trial · Interventional
Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas
Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial
NCT04248959CI-TRIAL-00072549PICaSO-EScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma,Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years and \<40 years of age at diagnosis * Fluent in English * Able to comply with study and follow-up procedures contained within the consent form * Pathologically or radiologically confirmed diagnosis of a soft-tissue or osteosarcoma of the upper or lower extremities * Soft-tissue or osteosarcoma must be considered operable * Patients of all weight bearing states will be eligible * Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator * \>14 days between time of randomization and time of expected surgery * Patient written, informed consent obtained according to ICH GCP guidelines and local regulations * Medical clearance to participate in the study from either the primary treating surgeon (JW, PF) or oncologist (AG) Exclusion Criteria: * Planned resection of bony pelvis or major lower extremity neurovascular structures * Significant comorbidity including any of the following: * Canadian Cardiovascular Society class III/IV coronary disease * New York Heart Association class III/IV congestive heart failure * Neurologic or musculoskeletal disorder prohibiting exercise * Major neuropsychiatric disorder * High-risk or presence of pathological fracture
References
Publications (0)
Data not yet available
No reference posted for this study.