STUDY00029300: ET-NEURO: A Pilot Trial of the Exercise Together Program in Primary Brain Tumor Patient-Caregiver Dyads Incorporating Glymphatic MRI
Bibliographic record
Abstract
Primary brain tumors (PBT), including glioblastoma and WHO grade 1-4 astrocytoma,Oligodendroglioma, and meningioma, are incurable malignancies associated with significant morbidity. Standard treatments, primarily oral chemotherapy and radiation, require extensive caregiver support, often from a co-residing partner. Both patients and caregivers experience high psychological distress and physical burden. While exercise is known to improve outcomes in cancer patients, its impact on the PBT patient-caregiver dyad remains unstudied. This trial will evaluate the feasibility, safety, and preliminary effects of Exercise Together, a partnered virtual functional resistance training program designed to support both PBT patients and their caregivers. We will conduct a single-center feasibility study enrolling 15-18 patient-caregiver dyads over 12 months. Patient-participants must be ≥6 weeks post radiation therapy for a PBT, function with a Karnofsky score ≥70, and co-reside with a caregiver-participant who is willing to enroll as a study partner. The 12-week intervention includes twice-weekly supervised sessions. Feasibility endpoints are ≥50% enrollment as well as ≥50% adherence and retention; safety will be monitored using CTCAE v5.0. Secondary objectives include preliminary changes in the patient participant-reported outcomes for distress (Distress Thermometer), fatigue (FACIT-F), and quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) together with the brain tumor–specific module QLQ-BN20. Caregiver participant’s quality of life will be measured using Distress Thermometer (DT), SF-36 questionnaire physical functioning subscale, and the Caregiver Quality of Life Index–Cancer (CQOLC) Scale. Patient and caregiver relationship quality will be measured using the dyadic coping measure. Descriptive statistics will summarize feasibility and safety, and linear mixed models will assess trends in quality-of-life measures. The optional exploratory objective will be to assess changes in the glymphatic system before, during, and after the exercise program by applying a perivascular space segmentation protocol using T1/T2-weighted imaging, integrated into standard-of-care monitoring MRI for patient-participants with primary brain tumors. This will be correlated with an optional cognitive test Montreal Cognitive Assessment, 5-minute protocol (MoCA) for patient participants. This pilot study will determine whether Exercise Together is a feasible supportive care intervention for PBT dyads. If feasible and beneficial, it will inform future multi-site trials and offer a novel strategy to improve outcomes by addressing both patient and caregiver needs.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".