Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES)

University Health Network, Toronto

Status: Completed

Conditions: Osteosarcoma; Sarcoma,Soft Tissue

Treatments: Behavioral: Multimodal prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04248959

18-5901

18-0226 (Other Identifier)

Details and patient eligibility

About

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).

Full description

Objectives:

This 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:

• 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%.
• To further determine the feasibility of conducting a larger phase II investigation of HIIT-based multimodal prehabilitation according to the secondary feasibility criteria.
• 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.

Methods:

A 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.

Participants 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.

Feasibility (e.g., recruitment, safety, tolerability), physical function, and patient-reported outcomes were measured at baseline (T0), immediately preoperatively (T1), and one month postoperatively (T2).

Feasibility 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Multimodal Prehabilitation

Experimental group

Description:

Facility and home-based multimodal prehabilitation (aerobic exercise training, resistance exercise training, nutrition support, stress management and mindfulness training)

Treatment:

Behavioral: Multimodal prehabilitation