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NCT Number: NCT07186556

Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention

The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.

Recruiting

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Michael Roth, MD

CONTACT

[email protected]

713-792-7751

Michael Roth, MD

PRINCIPAL_INVESTIGATOR

About this study

Primary Objective:

Test the efficacy of RISE-YA to improve CRF

Secondary Objectives:

  • Test the efficacy of RISE-YA to improve PA and physical function in fatigued YA brain tumor survivors.
  • Determine A) cross-sectional associations of CRF with oxidative phosphorylation (OxPhos) and with inflammation, and B) the effect of RISE-YA on OxPhos and on inflammation.

Exploratory Objective:

Assess the effect of our supervised exercise intervention on patient-reported health-related quality of life, muscle mass development (BMI, skinfold and circumferences [waist, arm, and calf area]), patient-reported dietary intake, and exercise adherence and progression.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is currently between the ages of 18-39 years
  • Their primary brain tumor was diagnosed at age 15-39 years
  • Is 6 months to <5 years post curative treatment
  • Has been treated with chemotherapy and radiation, given most patients receive both therapies.
  • Functional Assessment of Chronic Illness therapy (FACIT)-Fatigue ≤ 43. FACIT-Fatigue will be used as a screener because this 13-item scale can be completed relatively quickly in clinic
  • Currently engage in <150 minutes of PA and < 2 sessions of muscle strengthening exercise per week (assessed by Godin Leisure-Time PA Questionnaire)
  • Must be able to speak, write, and read English
  • No exercise contraindication as assessed by screening with the Physical Activity Readiness Questionnaire PAR-Q+. In addition, participants' care teams will be notified of their participation in the study.
  • Must be able to provide informed consent/assent.

Exclusion criteria

  • Non-English speaking
  • Screen failure for exercise safety
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
  • History of underlying chronic disease, secondary malignances, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
  • Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
  • Self-report of pregnancy
  • Prisoners
  • Documented developmental disorders (e.g., Autism) or major psychotic illness (e.g., schizophrenia)

Treatment and study plan

RISE-YA Intervention

Behavioral

Participants will receive energy conservation (EC) counseling, behavior coaching, and exercise training.

Survivorship Education

Behavioral

During weeks 1-6 and 1 time a week during Weeks 7-12, participants will receive a video call which will last about 60 minutes.

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Study contacts

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

Michael Roth, MD

CONTACT

[email protected]

(713) 792-7751

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Cancer Prevention Research Institute of Texas

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Sep 22, 2025
Registry last updated
Mar 4, 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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