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

Osteosarcoma Clinical Trial

— PICaSO-ES  

Official title:

Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248959
• Other study ID #: 18-5901
• Secondary ID: 18-0226
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: April 26, 2023

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma
• Sarcoma,Soft Tissue

Intervention

Behavioral:
• Multimodal prehabilitation
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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	MOUNT SINAI HOSPITAL

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global health score	Primary exploratory outcome: European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Postoperative complications	Postoperative complication severity and frequency defined according to the Common Terminology Criteria for Adverse Events.	1 month postoperative (T2)
Other	Length of stay	Average postoperative hospitalization period	1 month postoperative (T2)
Other	Functional capacity	Total distance traveled during six-minute walk test	Baseline (T0), preoperative (T1)
Other	Physical activity behavior (subjective)	Godin Leisure-time Exercise Questionnaire	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Health-related quality of life	EQ-5D; All 5 items are rated on a 1 to 3 scale with higher numbers reflecting worse outcomes.	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Symptom burden	Edmonton Symptom Assessment Scale (ESAS); All 10 items are rated on a 0 to 10 scale with higher numbers reflecting worse outcomes.	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS); All 14 items are rated on a 0 to 3 scale with higher numbers reflecting worse outcomes.	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F); All 13 items are rated on a 0 to 4 scale with higher numbers reflecting worse outcomes.	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Impact on work	Work Limitations Questionnaire	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Social support	Medical Outcomes Study Social Support Scale (SF-20); All item scores transformed into 0 to 100 scales with higher scores reflecting better outcomes.	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Relationships	Experiences in Close Relationships scale (ECR); All 36 items rated on a 1 to 7 scale with higher scores reflecting worse outcomes.	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Extremity function	Toronto Extremity Salvage Score (upper or lower)	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Other	Disease burden	Musculoskeletal Tumor Society score	Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Primary	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
Primary	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
Primary	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	Patient identification rate (feasibility target: >=50% of OEP)	Defined as the average number of OEP identified each month	Initiation through end of study recruitmentat 12 months
Secondary	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	Initiation through end of study recruitment at 12 months
Secondary	Intervention window (feasibility target: >=21 days)	Defined as the average elapsed time (in days) between diagnosis and extremity sarcoma surgery	Initiation through end of study intervention period
Secondary	Testing- and intervention-related non-serious adverse events (feasibility target: <20% of sessions)	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	Initiation through end of pre-operative testing
Secondary	Testing performance (feasibility target: >=95% completion of tests)	Defined as percent completion physical testing at baseline and follow-up	Initiation through end of pre-operative testing
Secondary	Testing modality adaptations (descriptive)	Defined as the percent of all tests which are adapted for functional or safety reasons	Initiation through end of pre-operative testing
Secondary	Training modality adaptations (descriptive)	Defined as the percent of all exercise sessions which are adapted for functional or safety reasons	Initiation through end of study intervention period
Secondary	Permanent treatment discontinuation (feasibility target: <=15% of participants)	Defined as the percent of patients who discontinue intervention participation prior to the planned end of the intervention period	Initiation through end of study intervention period
Secondary	Treatment interruption (feasibility target: <=15% of participants)	Defined as the percent of patients who miss =3 consecutive sessions within the intervention period	Initiation through end of study intervention period
Secondary	Dose modification (feasibility target: <=25% of participants)	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.	Initiation through end of study intervention period
Secondary	Early session termination (feasibility target: <=25% of participants)	Defined as the percent of exercise sessions requiring unplanned early termination	Initiation through end of study intervention period
Secondary	Pretreatment intensity modification (feasibility target: <=25% of participants)	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)	Initiation through end of study intervention period
Secondary	Physical prehabilitation compliance (feasibility target: >=70% of prescribed)	Defined as the percent of exercise sessions completed based on the total number of sessions prescribed	Initiation through end of study intervention period
Secondary	Mindfulness prehabilitation compliance (feasibility target: >=70% of prescribed)	Defined as the percent of psychological sessions completed based on the total number of sessions prescribed	Initiation through end of study intervention period
Secondary	Attrition (feasibility target: <=20% loss to follow-up)	Defined as the percent loss to follow-up (not completing follow-up assessments), individually and overall	Study initiation through end of 1 month postoperative (T2)