An Exercise Intervention for Improving Mental and Physical Health in Patients With Primary Brain Tumors and Their Caregivers, ET-NEURO Trial

NCT ID: NCT07278440

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2026-07-02

Brief Summary

This clinical trial evaluates the effects of a partnered exercise program, called Exercise Together, on participants with primary brain tumors and their caregivers. Standard treatments for primary brain tumors require extensive caregiver support, and both patients and caregivers experience high psychological distress and physical burden as a result. While exercise is known to improve outcomes in cancer patients, its impact on primary brain tumor patients and caregivers remains unstudied. Exercise Together is a supervised, group exercise program previously studied in patients with other types of cancer, though never in patients with primary brain tumors or their caregivers. Exercise Together uses functional resistance training to target muscle groups essential for everyday activities to improve daily functioning. Since exercises are done in a partnered format, Exercise Together is also designed to foster teamwork and strengthen the relationship between the patient and their caregiver. This program may be safe, feasible, and effective in improving the mental and physical health of primary brain tumor patients and their caregivers.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the safety and feasibility of the Exercise Together program for patient-participants with a diagnosis of primary brain tumor and their caregiver-participants.

SECONDARY OBJECTIVE:

I. To preliminarily evaluate the impact of the Exercise Together program on enhancing patient-caregiver relationships and improving quality of life in dyads affected with primary brain tumor (PBT).

EXPLORATORY OBJECTIVE:

I. To investigate the changes in the central nervous system (CNS) glymphatic system before, during, and after the exercise program and its association with cognition.

OUTLINE:

Patients and caregivers participate in Exercise Together virtual resistance training sessions, over 75 minutes each, twice weekly for 12 weeks. Patients may undergo magnetic resonance imaging (MRI) throughout the study as part of their standard care.

After completion of study intervention, participants are followed up at 4 weeks and then monthly in months 1-4.

Conditions

Primary Brain Neoplasm

Study Design

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

Study Groups

Supportive care (Exercise Together)

Patients and caregivers participate in Exercise Together virtual resistance training sessions, over 75 minutes each, twice weekly for 12 weeks. Patients may undergo MRI throughout the study as part of their standard care.

Group Type: EXPERIMENTAL

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Resistance Training

Intervention Type: OTHER

Participate in Exercise Together

Interventions

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Resistance Training

Participate in Exercise Together

Intervention Type: OTHER

Other Intervention Names

Magnetic Resonance; Magnetic Resonance Imaging (MRI); Magnetic resonance imaging (procedure); Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; MRIs; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; sMRI; Structural MRI; Strength Training

Eligibility Criteria

Inclusion Criteria

• PATIENT INCLUSION:
• Patient participants must have a histologically confirmed diagnosis of World Health Organization (WHO) grade 1-4 PBT such as glioblastoma, astrocytoma, oligodendroglioma, ependymoma, medulloblastoma, meningioma, and other primary brain tumors. Confirmed by review of the electronic medical record (EMR) and subsequently recorded in health history questionnaire. In cases where the EMR isn't clear, their Oregon Health & Science University OHSU provider will be contacted for confirmation
• Patient participants on active oral chemotherapy, including cytotoxic chemotherapy and molecularly targeted therapy, for the treatment of PBT are allowed
• Patient participants must be at least 6 weeks after the last dose of intravenous infusion chemotherapy for the treatment of PBT, including bevacizumab, prior to enrollment
• Patient participants must be at least 6 weeks post-radiation for PBT prior to enrollment. Patient participants must be at least 8 weeks post-craniotomy prior to enrollment
• Patient participants must have a co-residing spouse or partner caregiver due to the program's focus on intimacy
• Patient participants must have a Karnofsky performance score of at least 70 or an Eastern Cooperative Oncology Group (ECOG) score of 1 or less
• Patient participants are permitted to participate in other therapeutic interventional clinical trials for PBT
• PATIENT AND CAREGIVER INCLUSION:
• Patient participants and caregiver participants must be 18 years of age or older
• Patient participants and caregiver participants must state willingness to comply with all study procedures and availability for the duration of the study
• Patient participants and caregiver participants must have the ability to understand and the willingness to sign a written informed consent document
• Patient participants and caregiver participants must have home internet sufficient for videoconferencing

Exclusion Criteria

• PATIENT AND CAREGIVER EXCLUSION:
• Patient and caregiver participants must not have engaged in two or more regular strength training sessions per week (e.g., physical therapy) during the past 30 days, as confirmed by self-report on the health history questionnaire
• Patient participants and caregiver participants with cognitive difficulties preclude answering survey questions. In the event of a suspected undeclared cognitive impairment, it will be confirmed by physician clearance or professional opinion of the principal investigator
• Patient participants and caregiver participants with medical condition, movement condition, pre-existing focal neurological deficits, new focal deficits concerning for recurrent or progressive PBT necessitating second line treatment, post operative deficits/wound, or medication use that contraindicates participation in moderate intensity exercise. Specific contraindications include the following: poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, inability to ambulate without a walker or wheelchair, inability to stand for 3 minutes, severe hearing or vision problem

• Confirmed by a combination of reviewing the EMR, self-report on the health history questionnaire, and/or by physician clearance. All patient participants will receive physician clearance by the neuro-oncology investigators prior to participating in the trial. For caregiver participants: must answer 'No' to American College of Sports Medicine pre-participation screening questions. If caregiver participants answer 'Yes' to either question they may be required to obtain physician clearance prior to being considered eligible. Physician clearance may also be requested at the discretion of the principal investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Huan Vo, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anh Huan Vo

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Facility Contacts

Anh Huan Vo

Role: primary

vohu@ohsu.edu

503-494-4314

Other Identifiers

NCI-2025-08714

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00029300

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00029300

Identifier Type: -

Identifier Source: org_study_id