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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 39 Years
Gender	All

More 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07186556
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael Roth, MD
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer, Fatigue, Brain Tumor Adult
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Attention Control Group

Participants will randomized using incorrect baseline information.

Experimental: InItervention Group: Remote Implementation of Supervised Exercise for Young Adult

Participants will randomized using incorrect baseline information.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Houston 4699066, Texas 4736286

Status

Recruiting

Address

The University of Texas M. D. Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

Michael Roth, MD

[email protected]

713-792-7751

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