Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas

University Health Network, Toronto7 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sarcoma,Soft Tissue Osteosarcoma

Interventions

Multimodal prehabilitationBEHAVIORAL

Multimodal Prehabilitation * Aerobic exercise * Home-based, high-intensity interval training (HIIT), 2 days/week * Home-based, moderate-intensity continuous training (MICT), 2-3 days/week * Resistance exercise * 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 * Nutrition * Protein intake 1.2-1.5 g/kg body weight/day in compliance with European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines * Stress management * Daily mindfulness practice, 20 min/session, guided by audio file created at Mount Sinai Hospital

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Locations (1)

University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Patient recruitment rate (feasibility target: >=50% of eligible participants)

Defined as the percent of consenting patients based on the total number of otherwise eligible patients (OEP; patients meeting all study eligibility criteria) approached

Time frame: Initiation through end of study recruitment at 12 months

Testing- and intervention-related serious adverse events (feasibility target: none)

Defined as the number and frequency of testing- and intervention-related serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events

Time frame: Initiation through end of pre-operative testing

Patient exercise adherence (feasibility target: >=70% of prescribed)

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

Time frame: Initiation through end of study intervention period

Secondary Outcomes

Patient identification rate (feasibility target: >=50% of OEP)

Defined as the average number of OEP identified each month

Time frame: Initiation through end of study recruitmentat 12 months

Baseline assessment rate (feasibility target: >=90% of consenting participants)

Defined as the percent of consenting patients who successfully complete baseline assessments based on the total number of consenting patients

Time frame: Initiation through end of study recruitment at 12 months

Intervention window (feasibility target: >=21 days)

Defined as the average elapsed time (in days) between diagnosis and extremity sarcoma surgery

Data from ClinicalTrials.gov

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