An Exercise Intervention for Improving Mental and Physical Health in Patients With Primary Brain Tumors and Their Caregivers, ET-NEURO Trial (NCT07278440)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (7 items).
Location: OHSU Knight Cancer Institute โ Portland, Oregon
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- OHSU Knight Cancer Institute โ Portland, Oregon
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.