NCT07278440 · OHSU Knight Cancer Institute
An Exercise Intervention for Improving Mental and Physical Health in Patients With Primary Brain Tumors and Their Caregivers, ET-NEURO Trial
What this study is about
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.
View original scientific description
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.
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
Feasibility will be evaluated using an enrollment rate of ≥ 50% of eligible patient-caregiver dyads. Continuous variables will be characterized by N, mean or median, standard deviation or interquartile range; and discrete variables will be characterized by frequencies and proportions with exact 95% confidence intervals, as appropriate.
Adherence (feasibility)
Time frame: Up to 12 weeks
Feasibility will be evaluated using adherence, which will be defined as ≥ 50% of enrolled dyads completing at least 50% of the prescribed sessions (i.e., both members of the dyads attend ≥ 12 of 24 supervised exercise sessions). Continuous variables will be characterized by N, mean or median, standard deviation or interquartile range; and discrete variables will be characterized by frequencies and proportions with exact 95% confidence intervals, as appropriate.
Retention (feasibility)
Time frame: Up to 4 weeks after intervention completion
Feasibility will be evaluated using a retention rate of ≥ 50%. Continuous variables will be characterized by N, mean or median, standard deviation or interquartile range; and discrete variables will be characterized by frequencies and proportions with exact 95% confidence intervals, as appropriate.
Incidence of adverse events
Time frame: Up to 1-month post-exercise intervention
Defined as grade 3 or higher adverse events in both patient-participants and caregiver-participants, as per Common Terminology Criteria for Adverse Events version 5.0, directly attributable to the study intervention during the Exercise Together program. Continuous variables will be characterized by N, mean or median, standard deviation or interquartile range; and discrete variables will be characterized by frequencies and proportions with exact 95% confidence intervals, as appropriate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Portland, Oregon
Collaborators
National Cancer Institute (NCI), Oregon Health & Science University (OHSU)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2026 · Source of record for eligibility and locations