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

Official title

ET-NEURO: A Pilot Trial of the Exercise Together Program in Primary Brain Tumor Patient-Caregiver Dyads Incorporating Glymphatic MRI

Overview

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.

Interventions

• Other Electronic Health Record Review
  Ancillary studies
• Procedure Magnetic Resonance Imaging
  Undergo MRI
• Other Questionnaire Administration
  Ancillary studies
• Other Resistance Training
  Participate in Exercise Together

Primary outcome measures

• Enrollment rate (feasibility) [Time frame: Following screening at baseline]
• Adherence (feasibility) [Time frame: Up to 12 weeks]
• Retention (feasibility) [Time frame: Up to 4 weeks after intervention completion]
• Incidence of adverse events [Time frame: Up to 1-month post-exercise intervention]

Secondary outcome measures (2)

• Quality of life [Time frame: At baseline, 6 weeks, 12 weeks, and 16 weeks]
• Patient and caregiver relationship quality [Time frame: At baseline, 6 weeks, 12 weeks, and 16 weeks]

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
• Because this exercise intervention has not been evaluated in pregnant populations and the study team cannot provide the enhanced monitoring needed to ensure maternal and fetal safety, participants who are pregnant or planning pregnancy are excluded
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• OHSU Knight Cancer Institute — Portland

Identifiers

NCT: NCT07278440 · STUDY00029300 · NCI-2025-08714 · STUDY00029300 · P30CA069533

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗