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

NCT ID: NCT07186556

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2031-12-31

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.

Detailed 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.

Conditions

Cancer; Fatigue; Brain Tumor Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Attention Control Group

Participants will randomized using incorrect baseline information.

Group Type: EXPERIMENTAL

RISE-YA Intervention

Intervention Type: BEHAVIORAL

Participants will receive energy conservation (EC) counseling, behavior coaching, and exercise training.

InItervention Group: Remote Implementation of Supervised Exercise for Young Adult

Participants will randomized using incorrect baseline information.

Group Type: EXPERIMENTAL

Survivorship Education

Intervention Type: BEHAVIORAL

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.

Interventions

RISE-YA Intervention

Participants will receive energy conservation (EC) counseling, behavior coaching, and exercise training.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Roth, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Roth, MD

Role: CONTACT

mroth1@mdanderson.org

(713) 792-7751

Facility Contacts

Michael Roth, MD

Role: primary

mroth1@mdanderson.org

713-792-7751

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2025-06748

Identifier Type: OTHER

Identifier Source: secondary_id

2025-1036

Identifier Type: -

Identifier Source: org_study_id