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New treatment option for Primary Brain Neoplasm
Official title An Exercise Intervention for Improving Mental and Physical Health in Patients With Primary Brain Tumors and Their Caregivers, ET-NEURO Trial
ClinicalTrials.gov ID: NCT07278440
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- PATIENT INCLUSION:
- Patient participants must have a histologically confirmed diagnosis of World Health Organization (WHO) grade 1-4 PBT such as glioblastoma...
- Patient participants on active oral chemotherapy, including cytotoxic chemotherapy and molecularly targeted therapy, for the treatment of PBT are...
- Patient participants must be at least 6 weeks after the last dose of intravenous infusion chemotherapy for the treatment of PBT, including...
- Patient participants must be at least 6 weeks post-radiation for PBT prior to enrollment. Patient participants must be at least 8 weeks...
You likely can't join if
- 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...
- Patient participants and caregiver participants with cognitive difficulties preclude answering survey questions. In the event of a suspected...
- Because this exercise intervention has not been evaluated in pregnant populations and the study team cannot provide the enhanced monitoring needed to...
- Patient participants and caregiver participants with medical condition, movement condition, pre-existing focal neurological deficits, new focal...
- Confirmed by a combination of reviewing the EMR, self-report on the health history questionnaire, and/or by physician clearance. All patient...
See the full eligibility 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...
- 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 treatment 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
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.