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

Not Applicable

Completed

• Conditions: Osteosarcoma; Sarcoma,Soft Tissue
• Interventions: Behavioral: Multimodal prehabilitation

• Registration Number: NCT04248959
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Study Start: 2022-02-02
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multimodal Prehabilitation	Multimodal prehabilitation	Facility and home-based multimodal prehabilitation (aerobic exercise training, resistance exercise training, nutrition support, stress management and mindfulness training)

Primary Outcome Measures

Name	Time	Method
Patient exercise adherence (feasibility target: >=70% of prescribed)	Initiation through end of study intervention period	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
Testing- and intervention-related serious adverse events (feasibility target: none)	Initiation through end of pre-operative testing	Defined as the number and frequency of testing- and intervention-related serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events
Patient recruitment rate (feasibility target: >=50% of eligible participants)	Initiation through end of study recruitment at 12 months	Defined as the percent of consenting patients based on the total number of otherwise eligible patients (OEP; patients meeting all study eligibility criteria) approached

Secondary Outcome Measures

Name	Time	Method
Mindfulness prehabilitation compliance (feasibility target: >=70% of prescribed)	Initiation through end of study intervention period	Defined as the percent of psychological sessions completed based on the total number of sessions prescribed
Attrition (feasibility target: <=20% loss to follow-up)	Study initiation through end of 1 month postoperative (T2)	Defined as the percent loss to follow-up (not completing follow-up assessments), individually and overall
Training modality adaptations (descriptive)	Initiation through end of study intervention period	Defined as the percent of all exercise sessions which are adapted for functional or safety reasons
Testing- and intervention-related non-serious adverse events (feasibility target: <20% of sessions)	Initiation through end of pre-operative testing	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
Patient identification rate (feasibility target: >=50% of OEP)	Initiation through end of study recruitmentat 12 months	Defined as the average number of OEP identified each month
Baseline assessment rate (feasibility target: >=90% of consenting participants)	Initiation through end of study recruitment at 12 months	Defined as the percent of consenting patients who successfully complete baseline assessments based on the total number of consenting patients
Intervention window (feasibility target: >=21 days)	Initiation through end of study intervention period	Defined as the average elapsed time (in days) between diagnosis and extremity sarcoma surgery
Testing performance (feasibility target: >=95% completion of tests)	Initiation through end of pre-operative testing	Defined as percent completion physical testing at baseline and follow-up
Testing modality adaptations (descriptive)	Initiation through end of pre-operative testing	Defined as the percent of all tests which are adapted for functional or safety reasons
Permanent treatment discontinuation (feasibility target: <=15% of participants)	Initiation through end of study intervention period	Defined as the percent of patients who discontinue intervention participation prior to the planned end of the intervention period
Treatment interruption (feasibility target: <=15% of participants)	Initiation through end of study intervention period	Defined as the percent of patients who miss ≥3 consecutive sessions within the intervention period
Dose modification (feasibility target: <=25% of participants)	Initiation through end of study intervention period	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.
Early session termination (feasibility target: <=25% of participants)	Initiation through end of study intervention period	Defined as the percent of exercise sessions requiring unplanned early termination
Pretreatment intensity modification (feasibility target: <=25% of participants)	Initiation through end of study intervention period	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)
Physical prehabilitation compliance (feasibility target: >=70% of prescribed)	Initiation through end of study intervention period	Defined as the percent of exercise sessions completed based on the total number of sessions prescribed

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada