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Recruiting NCT07186556

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

No phase Interventional Cancer Fatigue Brain Tumor Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RISE-YA Intervention, Survivorship Education.
Who it may be relevant to
Registry conditions: Cancer, Fatigue, Brain Tumor Adult. Basic parameters: 18 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Primary Objective:

Test the efficacy of RISE-YA to improve CRF

Secondary Objectives:

1. Test the efficacy of RISE-YA to improve PA and physical function in fatigued YA brain tumor survivors. 2. 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.

Interventions

  • Behavioral RISE-YA Intervention
    Participants will receive energy conservation (EC) counseling, behavior coaching, and exercise training.
  • Behavioral Survivorship Education
    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 outcome measures

  • Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year]

Eligibility criteria

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)

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The University of Texas M. D. Anderson Cancer Center — Houston

Identifiers

NCT: NCT07186556 · 2025-1036 · NCI-2025-06748

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗