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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma; Bone Sarcoma; Soft Tissue Sarcoma (STS)
• Intervention / Treatment: Behavioral: Exercise Triage and 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vinayak Venkataraman, MD; Phone Number: 617-632-5204; Email: vinayak_venkataraman@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
      • Contact: Vinayak Venkataraman, MD; Phone Number: 617-632-5204; Email: vinayak_venkataraman@dfci.harvard.edu
      • Principal Investigator: Vinayak Venkataraman, MD
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
      • Contact: Vinayak Venkataraman, MD; Phone Number: 617-632-5204; Email: vinayak_venkataraman@dfci.harvard.edu
      • Principal Investigator: Vinayak Venkataraman, MD
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
      • Contact: Vinayak Venkataraman, MD; Phone Number: 617-632-5204; Email: vinayak_venkataraman@dfci.harvard.edu
      • Principal Investigator: Vinayak Venkataraman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Exercise Triage and Personalized Exercise Program; All participants receive this intervention.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
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.	Within 2 months of EXCEEDS completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Height from Baseline	Height is obtained from clinical visits or measured by study staff.	Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Body Weight from Baseline	Weight is obtained from clinical visits or measured by study staff.	Assessed at pre-program (baseline) and post-program (12 weeks).
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.	Assessed at pre-program (baseline) and post-program (12 weeks).
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.	Assessed at pre-program (baseline) and post-program (12 weeks).
Change in 6-Minute Walk Distance from Baseline	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.	Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Lower Quarter Y-Balance Composite Score from Baseline	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.	Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Upper Extremity Strength from Baseline	Upper-extremity strength assessed using the Grip Strength Test. Grip strength is measured using a hand dynamometer.	Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Number of Repetitions Completed from Baseline	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.	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	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.	Assessed at pre-program (baseline) and post-program (12 weeks).

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Vinayak Venkataraman, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: soft tissue sarcoma; sarcoma; bone sarcoma
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Bone Neoplasms
• Other Study ID Numbers: 26-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No