About this trial
This study will evaluate strategies to improve physical function and promote exercise and physical activity in adolescents and young adults (AYAs) with sarcoma. The study will assess the feasibility of a standardized triage system for referring AYAs with sarcoma to appropriate exercise and rehabilitation services, and will also examine changes in physical function and health-related quality of life before and after a 12-week personalized exercise program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with a bone or soft tissue sarcoma
Age 15-39 at time of diagnosis
Age 15 and older at time of enrollment
Age 15-17 at time of enrollment, with assent from participant and consent from parent/legal guardian
Disqualifiers
Unstable cardiovascular disease in the last 6 months
Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, untreated substance use disorder, severe personality disorder)
Pregnant
Currently participating in physical or occupational therapy
Trial design
Single group
Treatments tested in this trial
Exercise Triage and Personalized Exercise Program
Behavioral* Part 1: Completion of the EXCEEDS triage tool to assess physical function and determine appropriate referral to rehabilitation or exercise services. * Part 2: Eligible participants receive a 12-week personalized exercise program, which may be supervised or unsupervised, and includes a Garmin activity monitor, resistance bands, and a stepper machine.
Treatment groups
Trial outcomes
Primary outcomes
Triage Tool Completion Rate
Triage tool completion rate is defined as the proportion of consented participants who fully completed the Exercise in Cancer Evaluation and Decision Support (EXCEEDS) tool.
Referral Completion Rate
Referral completion rate is defined as the rate of participants who completed the EXCEEDS tool and subsequently completed an initial visit with an occupational therapist (OT), physical therapist (PT), trainer, or health coach.
Secondary outcomes
Change in Height from Baseline
Height is obtained from clinical visits or measured by study staff.
Change in Body Weight from Baseline
Weight is obtained from clinical visits or measured by study staff.
Change in Total Leisure Activity Score from Baseline
Total Leisure Activity Score is calculated from the reported weekly frequency of strenuous, moderate, and light leisure-time physical activity sessions lasting at least 15 minutes, based on Godlin Leisure-Time Questionnaire. The total score is calculated as (9 × strenuous sessions/week) + (5 × moderate sessions/week) + (3 × light sessions/week). Higher scores indicate greater leisure-time physical activity.
Change in Peak Oxygen Consumption (VO₂ Peak) from Baseline
VO₂ peak is estimated using the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill Protocol based on the highest completed stage.
Sponsors and contacts
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