NCT07186556

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
69mo left

Started Sep 2025

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Sep 2025Dec 2031

Study Start

First participant enrolled

September 9, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

September 15, 2025

Last Update Submit

March 2, 2026

Conditions

Brain Tumor AdultCancerFatigue

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (2)

Attention Control Group

EXPERIMENTAL

Participants will randomized using incorrect baseline information.

Behavioral: RISE-YA Intervention

InItervention Group: Remote Implementation of Supervised Exercise for Young Adult

EXPERIMENTAL

Participants will randomized using incorrect baseline information.

Behavioral: Survivorship Education

Interventions

RISE-YA InterventionBEHAVIORAL

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

Attention Control Group
Survivorship EducationBEHAVIORAL

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.

InItervention Group: Remote Implementation of Supervised Exercise for Young Adult

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Roth, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Roth, MD

CONTACT

(713) 792-7751mroth1@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

March 4, 2026

Record last verified: 2026-03

Locations

US(1)