NCT07186556 Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention
| NCT ID | NCT07186556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2025-09-09 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Michael Roth, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT07186556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 39 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07186556 currently recruiting?
Yes, NCT07186556 is actively recruiting participants. Contact the research team at mroth1@mdanderson.org for enrollment information.
Where is the NCT07186556 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07186556 clinical trial?
NCT07186556 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Michael Roth, MD at M.D. Anderson Cancer Center. The trial plans to enroll 75 participants.
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