RISE‑YA tele‑exercise to reduce fatigue in young adult brain tumor survivors
Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention
This project will test whether a supervised tele‑exercise program called RISE‑YA helps reduce cancer‑related fatigue in young adults who survived brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07186556 on ClinicalTrials.gov |
What this trial studies
This interventional program delivers a supervised tele‑exercise intervention (RISE‑YA) alongside survivorship education for fatigued young adult brain tumor survivors. The primary outcome is change in cancer‑related fatigue measured by the FACIT‑Fatigue scale, with secondary outcomes including physical activity, physical function, and biomarkers of oxidative phosphorylation and inflammation. Exploratory outcomes include quality of life, muscle mass measures, dietary intake, and exercise adherence and progression. Participants are aged 18–39, 6 months to under 5 years after curative treatment, and must have received chemotherapy and radiation.
Who should consider this trial
Good fit: Ideal candidates are English‑speaking brain tumor survivors aged 18–39 (diagnosed at 15–39), 6 months to <5 years after curative treatment who received chemotherapy and radiation, report clinically significant fatigue (FACIT‑Fatigue ≤43), and are currently underactive (<150 minutes/week of activity and <2 strength sessions/week) with no exercise contraindications.
Not a fit: People outside the age or post‑treatment window, those who were not treated with chemotherapy and radiation, highly active individuals, non‑English speakers, or those with medical conditions that prevent safe exercise are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, RISE‑YA could reduce fatigue and improve physical function and quality of life for young adult brain tumor survivors.
How similar studies have performed: Exercise programs have reduced cancer‑related fatigue in other cancer survivor groups, but RISE‑YA is relatively novel for young adult brain tumor survivors and pairs tele‑exercise with biomarker measurements.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Is currently between the ages of 18-39 years 2. Their primary brain tumor was diagnosed at age 15-39 years 3. Is 6 months to \<5 years post curative treatment 4. Has been treated with chemotherapy and radiation, given most patients receive both therapies. 5. 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 6. Currently engage in \<150 minutes of PA and \< 2 sessions of muscle strengthening exercise per week (assessed by Godin Leisure-Time PA Questionnaire) 7. Must be able to speak, write, and read English 8. 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. 9. Must be able to provide informed consent/assent. Exclusion Criteria: 1. Non-English speaking 2. Screen failure for exercise safety 3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease 4. Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions 5. History of underlying chronic disease, secondary malignances, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain 6. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team. 7. Self-report of pregnancy 8. Prisoners 9. Documented developmental disorders (e.g., Autism) or major psychotic illness (e.g., schizophrenia)
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Michael Roth, MD — M.D. Anderson Cancer Center
- Study coordinator: Michael Roth, MD
- Email: mroth1@mdanderson.org
- Phone: (713) 792-7751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.