RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-09

Study Completion:2031-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07186556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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)

Inclusion Criteria

Exclusion 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.

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)

Contacts and Locations

Study Contact

Michael Roth, MD

CONTACT

(713) 792-7751

mroth1@mdanderson.org

Principal Investigator

Michael Roth, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Michael Roth, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-09

Study Completion Date2031-12-31

Study Record Updates

Study Start Date2025-09-09

Study Completion Date2031-12-31

Terms related to this study

Additional Relevant MeSH Terms

Cancer
Fatigue
Brain Tumor Adult