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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Cancer; Fatigue; Brain Tumor Adult

Treatments: Behavioral: Survivorship Education; Behavioral: RISE-YA Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07186556

NCI-2025-06748 (Other Identifier)

2025-1036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Attention Control Group

Experimental group

Description:

Participants will randomized using incorrect baseline information.

Treatment:

Behavioral: RISE-YA Intervention

InItervention Group: Remote Implementation of Supervised Exercise for Young Adult

Experimental group

Description:

Participants will randomized using incorrect baseline information.

Treatment:

Behavioral: Survivorship Education