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NCT Number: NCT07662239

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

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.

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Key information

Conditions

Sarcoma Bone Diseases Bone Neoplasms Bone Sarcoma Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Soft Tissue Sarcoma (STS)

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Triage Tool Completion Rate

    Time frame: 2 weeks

    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.

  2. Referral Completion Rate

    Time frame: Within 2 months of EXCEEDS completion

    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

  1. Change in Height from Baseline

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

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

  2. Change in Body Weight from Baseline

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

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

  3. Change in Total Leisure Activity Score from Baseline

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

    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.

  4. Change in Peak Oxygen Consumption (VO₂ Peak) from Baseline

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

    VO₂ peak is estimated using the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill Protocol based on the highest completed stage.

  5. Change in 6-Minute Walk Distance from Baseline

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

    The test measures the total distance walked in meters during a 6-minute period and is performed for participants unable to complete the UNCCRI Treadmill Protocol.

  6. Change in Lower Quarter Y-Balance Composite Score from Baseline

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

    Lower Quarter Y-Balance Composite Score is calculated as the sum of the anterior, posteromedial, and posterolateral reach distances divided by three times the limb length and multiplied by 100. The score is expressed as a percentage of limb length, with higher scores indicating better dynamic balance and lower-extremity functional performance.

  7. Change in Upper Extremity Strength from Baseline

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

    Upper-extremity strength assessed using the Grip Strength Test. Grip strength is measured using a hand dynamometer.

  8. Change in Number of Repetitions Completed from Baseline

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

    The number of repetitions completed during the 30-Second Sit-to-Stand Test is defined as the total number of completed sit-to-stand repetitions within 30 seconds.

  9. 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).

    PROMIS-29 includes the domains of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference scores are each derived from 4 questions scored on a 5-point scale, with total scores ranging from 4 to 20 for each domain. Higher scores indicate better functioning for physical function and ability to participate in social roles and activities, and worse symptoms for anxiety, depression, fatigue, sleep disturbance, and pain interference. Pain intensity is assessed using a single question scored from 0 to 10, with higher scores indicating greater pain intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Vinayak Venkataraman, MD

CONTACT

[email protected]

617-632-5204

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: AYA-ONE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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