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

Overview

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.

Detailed description

This is a single-arm pilot study evaluating the feasibility of using a modified Exercise in Cancer Evaluation and Decision Support (EXCEEDS) algorithm to triage and refer adolescents and young adults (AYAs) with sarcoma to rehabilitation and exercise services at Dana-Farber Cancer Institute (DFCI). The AYA-ONE study has two parts: Part 1 includes triage and referral using the EXCEEDS tool, and Part 2 includes a 12-week personalized exercise program for eligible participants. The EXCEEDS tool is designed to help match participants to rehabilitation and exercise services based on their needs. Participants in Part 2 will receive a Garmin activity monitor, resistance bands, a stepper machine, and a 12-week exercise program, which may be supervised or unsupervised.

The research study procedures include: screening for eligibility, triage and referral using the EXCEEDS tool, rehabilitation and exercise service referral, and, for eligible participants, a 12-week personalized exercise program.

It is expected that about 40 people will take part in Part 1 of this study. About 20 people are expected to participate in the full study, including both Part 1 and Part 2.

Participation in this research study is expected to last about 6 months.

Interventions

• Behavioral Exercise Triage and Personalized Exercise Program
  * 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.

Primary outcome measures

• Triage Tool Completion Rate [Time frame: 2 weeks]
• Referral Completion Rate [Time frame: Within 2 months of EXCEEDS completion]

Secondary outcome measures (9)

• Change in Height from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in Body Weight from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in Total Leisure Activity Score from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in Peak Oxygen Consumption (VO₂ Peak) from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in 6-Minute Walk Distance from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in Lower Quarter Y-Balance Composite Score from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in Upper Extremity Strength from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in Number of Repetitions Completed from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]
• Change in PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-Item Profile) Score from Baseline [Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).]

Eligibility criteria

Inclusion criteria

• 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
• Established patient of the DFCI Sarcoma Center or Jimmy Fund
• Able to read and understand English (to complete required questionnaires and participate in training/coaching)
• Individuals who are not yet adults (teenagers) if they assent and their parents/legal guardians' consent to participation.

Exclusion criteria

• 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
• Presence of medical conditions or medications that would prohibit participation in an exercise program
• Meeting exercise guidelines of 150 minutes of moderate intensity/75 minutes of vigorous intensity physical activity per week plus consistent strength training (at least once per week) over the past 3 months. Assessed via Godin Leisure Time Questionnaire by study staff.
• Adults unable to consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 3 centers

• Boston Children's Hospital — Boston
• Brigham and Women's Hospital — Boston
• Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT07662239 · 26-106

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗