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

NCT07662239 | Not Yet Recruiting DMC

• 1 other identifier: 26-106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Sarcoma; Bone Sarcoma; Soft Tissue Sarcoma (STS)

Keywords

sarcoma; bone sarcoma; soft tissue sarcoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in Height from Baseline

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

• Change in Body Weight from Baseline

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

• Change in Total Leisure Activity Score from Baseline

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

• Change in Peak Oxygen Consumption (VO₂ Peak) from Baseline

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

• Change in 6-Minute Walk Distance from Baseline

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

Study Arms (1)

Exercise Triage and Personalized Exercise Program

EXPERIMENTAL

All participants receive this intervention.

Behavioral: Exercise Triage and Personalized Exercise Program

Interventions

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.

Exercise Triage and Personalized Exercise Program

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Vinayak Venkataraman, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinayak Venkataraman, MD

CONTACT

617-632-5204; vinayak_venkataraman@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu.

Locations

US (3)