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

NCT07186556 | Recruiting DMC

• 2 other identifiers: 2025-1036NCI-2025-06748
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Brain Tumor Adult; Cancer; Fatigue

Outcome Measures

Primary Outcomes (1)

• Cancer Related Fatigue

  To compare changes in cancer related fatigue at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: Multi-dimensional Fatigue Inventory. Scores range from 20 to 100, with higher values indicating greater fatigue severity

  Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Secondary Outcomes (14)

• Physical Activity (PS)

  Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

• Physical Function: Timed up and Go

  Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

• Physical Function: Single Leg Stand

  Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

• Physical Function: 1-minute chair stand

  Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

• Physical Function: 6-minute walk test

  Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Study Arms (2)

Participant Group/Arm

EXPERIMENTAL

Participants will randomized at baseline stratifying by gender and CRF level

Behavioral: Survivorship Education

Intervention Group

EXPERIMENTAL

Participants will randomized at baseline stratifying by gender and CRF level

Behavioral: RISE-YA Intervention

Interventions

RISE-YA Intervention BEHAVIORAL

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.

Intervention Group

Survivorship Education BEHAVIORAL

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

Participant Group/Arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is currently between the ages of 18-39 years
• Their primary brain tumor was diagnosed at age 15-39 years
• Is 6 months to \<5 years post curative treatment
• Has been treated with chemotherapy and radiation, given most patients receive both therapies.
• 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
• Currently engage in \<150 minutes of PA and \< 2 sessions of muscle strengthening exercise per week (assessed by Godin Leisure-Time PA Questionnaire)
• Must be able to speak, write, and read English
• 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.
• Must be able to provide informed consent/assent.

You may not qualify if:

• Non-English speaking
• Screen failure for exercise safety
• Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
• Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
• History of underlying chronic disease, secondary malignances, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
• Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
• Self-report of pregnancy
• Prisoners
• Documented developmental disorders (e.g., Autism) or major psychotic illness (e.g., schizophrenia)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cancer Prevention Research Institute of Texas: collaborator
• UTHealth School of Medicine: collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Roth, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Roth, MD

CONTACT

(713) 792-7751; mroth1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)