Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Patient exercise adherence (feasibility target: >=70% of prescribed)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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)
排除标准
- •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
结局指标
主要结局
Patient exercise adherence (feasibility target: >=70% of prescribed)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- Mindfulness prehabilitation compliance (feasibility target: >=70% of prescribed)(Initiation through end of study intervention period)
- Attrition (feasibility target: <=20% loss to follow-up)(Study initiation through end of 1 month postoperative (T2))
- Training modality adaptations (descriptive)(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)
- 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 performance (feasibility target: >=95% completion of tests)(Initiation through end of pre-operative testing)
- Testing modality adaptations (descriptive)(Initiation through end of pre-operative testing)
- Permanent treatment discontinuation (feasibility target: <=15% of participants)(Initiation through end of study intervention period)
- Treatment interruption (feasibility target: <=15% of participants)(Initiation through end of study intervention period)
- Dose modification (feasibility target: <=25% of participants)(Initiation through end of study intervention period)
- Early session termination (feasibility target: <=25% of participants)(Initiation through end of study intervention period)
- Pretreatment intensity modification (feasibility target: <=25% of participants)(Initiation through end of study intervention period)
- Physical prehabilitation compliance (feasibility target: >=70% of prescribed)(Initiation through end of study intervention period)
研究者
Daniel Santa Mina
Clinician Investigator
University Health Network, Toronto