ET-NEURO: A Pilot Trial of the Exercise Together Program in Primary Brain Tumor Patient-Caregiver Dyads Incorporating Glymphatic MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Adherence (feasibility)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Supportive care (Exercise Together)
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.
干预措施: Resistance Training (Other)
Supportive care (Exercise Together)
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.
干预措施: Electronic Health Record Review (Other)
Supportive care (Exercise Together)
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.
干预措施: Questionnaire Administration (Other)
Supportive care (Exercise Together)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Adherence (feasibility)
时间窗: 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)
时间窗: 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
时间窗: 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.
Enrollment rate (feasibility)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Quality of life(At baseline, 6 weeks, 12 weeks, and 16 weeks)
- Patient and caregiver relationship quality(At baseline, 6 weeks, 12 weeks, and 16 weeks)
研究者
Huan Vo, M.D.
Principal Investigator
OHSU Knight Cancer Institute