Recruiting

RISE-YA

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07186556

Conditions

Cancer

Fatigue

Brain Tumor Adult

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Survivorship Education

RISE-YA Intervention

Study Details

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.

Conditions

Cancer

Fatigue

Brain Tumor Adult

Study ID

NCT07186556

Start date

Sep 9, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Participant Group/Arm

Participants will randomized at baseline stratifying by gender and CRF level

experimental: Intervention Group

Participants will randomized at baseline stratifying by gender and CRF level

Interventions

Survivorship Education

Participants will participate in discussions with a trainer via videoconference of any adverse events, resolving technical issues related to the activity tracker, and discussing survivorship topics using the NCI's Facing Forward Life After Cancer Treatment booklet. Participants will receive calls twice weekly during weeks 1-6 and once weekly during weeks 7-12

RISE-YA Intervention

Participants will receive one-on-one energy conservation (EC) counseling, behavior coaching, and individualized, progressive strength and aerobic training exercises with a trainer via videoconference. Participants will receive calls twice weekly during weeks 1-6 and once weekly during weeks 7-12. Each call will last one hour. Participants will also receive prescriptions for self-led exercise sessions.

Primary outcome measure

  • Cancer Related Fatigue [ Time Frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks) ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Michael Roth, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-12.