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

NCT04248959 | Completed

• 2 other identifiers: 18-590118-0226
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Sarcoma,Soft Tissue; Osteosarcoma

Keywords

Preoperative Care; Exercise Therapy; Prehabilitation; Extremity Sarcoma; Adolescents and Young Adults

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Initiation through end of study intervention period

Secondary Outcomes (15)

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

  Initiation through end of study recruitmentat 12 months

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

  Initiation through end of study recruitment at 12 months

• Intervention window (feasibility target: >=21 days)

  Initiation through end of study intervention period

• Testing- and intervention-related non-serious adverse events (feasibility target: <20% of sessions)

  Initiation through end of pre-operative testing

• Testing performance (feasibility target: >=95% completion of tests)

  Initiation through end of pre-operative testing

Other Outcomes (14)

• Global health score

  Baseline (T0), preoperative (T1), 1 month postoperative (T2)

• Postoperative complications

  1 month postoperative (T2)

• Length of stay

  1 month postoperative (T2)

Study Arms (1)

Multimodal Prehabilitation

EXPERIMENTAL

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

Behavioral: Multimodal prehabilitation

Interventions

Multimodal prehabilitation BEHAVIORAL

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

Multimodal Prehabilitation

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• MOUNT SINAI HOSPITAL: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

MeSH Terms

Conditions

Sarcoma; Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Study Officials

• Daniel R Santa Mina, PhD

  University of Toronto; University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 30, 2020
• Study Start: February 2, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)