An Exercise Intervention for Improving Mental and Physical Health in Patients With Primary Brain Tumors and Their Caregivers, ET-NEURO Trial

N/ANot Yet RecruitingNCT07278440

OHSU Knight Cancer Institute36 enrolled

Overview

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.

PRIMARY OBJECTIVE: I. 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: I. 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: I. 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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 1-month post-exercise intervention

Secondary Outcomes

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. 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. 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.

Time frame: 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.