Primary Brain NeoplasmNCT07278440
An Exercise Intervention for Improving Mental and Physical Health in Patients With Primary Brain Tumors and Their Caregivers, ET-NEURO Trial
A study testing Electronic Health Record Review, Magnetic Resonance Imaging and Questionnaire Administration in people with Primary Brain Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Brain Neoplasm
- What is being tested?
- Electronic Health Record Review, Magnetic Resonance Imaging and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2026to 2 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT INCLUSION:
- Patient participants must have a diagnosis of World Health Organization (WHO) grade 1-4 PBT such as glioblastoma, astrocytoma, oligodendroglioma, ependymoma, medulloblastoma, meningioma, and other primary brain tumors as determined by the treating physician/neuro-oncologist. 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
Show all 13Show fewer
- 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
Who cannot join
- PATIENT AND CAREGIVER EXCLUSION:
- Patient 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. Caregiver participants are allowed to engage in strength training outside of the program
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Anh Huan Vo, 503-494-4314, vohu@ohsu.edu
Anh Huan Vo
About this study
Official title: ET-NEURO: A Pilot Trial of the Exercise Together Program in Primary Brain Tumor Patient-Caregiver Dyads Incorporating Glymphatic MRI
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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
- Being tested
- Electronic Health Record Review, Magnetic Resonance Imaging, Questionnaire Administration, Resistance Training
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Questionnaire AdministrationOther
Ancillary studies
Resistance TrainingOther
Also called Strength Training
Participate in Exercise Together
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Exercise Together) | Experimental | 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. Receives: Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate (feasibility)
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.
Measured: Following screening at baseline
Adherence (feasibility)
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.
Measured: Up to 12 weeks
Retention (feasibility)
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.
Measured: Up to 4 weeks after intervention completion
Incidence of adverse events
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.
Measured: Up to 1-month post-exercise intervention
Secondary outcomes (2)
Quality of life
Appropriate summary statistics (e.g., mean or median, standard deviation or interquartile range) will be used to characterize quality of life measures at each time point for the following questionnaires for patient participants: Distress Thermometer (DT), Functional Assessment of Chronic Illness Therapy fatigue questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 together with the brain tumor-specific module and cancer loneliness scale. For caregiver participants, will use the following: DT, Short Form-36 questionnaire physical functioning subscale, as well as Caregiver Quality of Life Index-Cancer scale and the caregiver cancer loneliness scale. 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.
Measured: At baseline, 6 weeks, 12 weeks, and 16 weeks
Patient and caregiver relationship quality
Will be measured using the dyadic coping measure. A linear mixed model will be used to quantify the trend over time and estimate the changes from baseline to each follow up time point. Hypothesis tests may be conducted for exploratory purposes and signal detection. Variation of time trend by patient characteristics may also be explored cautiously. Model assumptions will be checked and if not satisfied, alternative methods will be used. 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.
Measured: At baseline, 6 weeks, 12 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start24 Aug 2026
- Primary completion2 May 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health & Science University (OHSU)
- Responsible party
- Principal investigator, Huan Vo, M.D., OHSU Knight Cancer Institute
- Investigators
- Anh Huan Vo, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278440
- Sponsor's protocol ID
- STUDY00029300
- Other IDs
- NCI-2025-08714, STUDY00029300, P30CA069533
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ET-NEURO: A Pilot Trial of the Exercise Together Program in Primary Brain Tumor Patient-Caregiver Dyads Incorporating Glymphatic MRI
- ClinicalTrials.gov ID
- NCT07278440
- Acronym / sponsor ID
- STUDY00029300
- Conditions
- Primary Brain Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health & Science University (OHSU)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 Aug 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Exercise Together) | Experimental | Other: Electronic Health Record Review, Procedure: Magnetic Resonance Imaging, Other: Questionnaire Administration, Other: Resistance TrainingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- PATIENT INCLUSION:
- Patient participants must have a diagnosis of World Health Organization (WHO) grade 1-4 PBT such as glioblastoma, astrocytoma, oligodendroglioma, ependymoma, medulloblastoma, meningioma, and other primary brain tumors as determined by the treating physician/neuro-oncologist. 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
Key exclusion criteria (6 listed)
- PATIENT AND CAREGIVER EXCLUSION:
- Patient 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. Caregiver participants are allowed to engage in strength training outside of the program
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (Exercise Together) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Supportive care (Exercise Together) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (Exercise Together) |
| Resistance TrainingAlso: Strength TrainingParticipate in Exercise Together | Other | Supportive care (Exercise Together) |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anh Huan Vo principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record Review, Magnetic Resonance Imaging and Questionnaire Administration in people with Primary Brain Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (feasibility) (time frame: Following screening at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.