Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-39
SponsorDana-Farber Cancer Institute

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 volunteers

Qualifiers

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

Design model

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

40 Participants
are divided into 1 treatment group
Group A: Exercise Triage and Personalized Exercise ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 weeks
2

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.

Time frame
Within 2 months of EXCEEDS completion

Secondary outcomes

1

Change in Height from Baseline

Height is obtained from clinical visits or measured by study staff.

Time frame
Assessed at pre-program (baseline) and post-program (12 weeks).
2

Change in Body Weight from Baseline

Weight is obtained from clinical visits or measured by study staff.

Time frame
Assessed at pre-program (baseline) and post-program (12 weeks).
3

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.

Time frame
Assessed at pre-program (baseline) and post-program (12 weeks).
4

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.

Time frame
Assessed at pre-program (baseline) and post-program (12 weeks).

Other outcomes

Sponsors and contacts

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