Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Adoption
研究概览
简要总结
This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in breast cancer survivors (BCS) aged 50 and older (N=160).
II. Gather information on the intervention's potential for scalability using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
EXPLORATORY OBJECTIVES:
I. Explore potential moderators and mediators of the effects of aerobic exercise training on cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and/or clinical determination
- •PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and/or clinical determination
- •PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to registration according to participant report and/or clinical determination
- •PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months
- •PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance
- •REGISTRATION: Age ≥50 years as confirmed via clinical determination
- •REGISTRATION: Able to provide medical record release to confirm eligibility
- •REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination
- •REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to pre-registration as confirmed via clinical determination
- •REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score > 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy
- •REGISTRATION: Receive physician's clearance to participate in an exercise program
- •NOTE: Individuals with conditions/diagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:
- •History of major multiple myocardial infarctions (MI)
- •Recent electrocardiogram (ECG) changes or recent MI
- •Resting or unstable angina
- •Significant multivessel coronary occlusion (≥ 70%) on angiography
- •Uncontrolled and/or serious arrhythmias
- •3rd degree heart block
- •Acute congestive heart failure or ejection fraction < 30%
- •REGISTRATION: Ability to complete assessments by themselves or with assistance
排除标准
- •PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease
- •PRE-REGISTRATION: Currently receiving or < 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 60 months post primary treatment
- •PRE-REGISTRATION: Planned surgery during the intervention period
- •PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)
- •PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- •PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up
- •PRE-REGISTRATION: Self-reported inability to walk without assistance or devices
- •REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
- •REGISTRATION: Clinically significant TICS-M score (< 21) during baseline procedures
- •REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)
- •REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols
- •REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable/abnormal limited diagnostic brain image with recommended medical follow-up
- •REGISTRATION: Enrolled in another physical activity program
- •REGISTRATION: Unable to walk without assistance or devices
- •REGISTRATION: Unwilling to complete study requirements
- •REGISTRATION: Unwilling to be randomized to the exercise group or health education group
- •REGISTRATION: Unable or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period
- •REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- •REGISTRATION: Unwilling to return to enrolling institution for follow-up
研究组 & 干预措施
Arm I (Aerobic Exercise)
Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study.
干预措施: Aerobic Exercise Training (Behavioral)
Arm II (Health Education)
Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.
干预措施: Health Education (Active comparator) (Other)
结局指标
主要结局
Adoption
时间窗: post-intervention (month 6)
Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers
Maintenance
时间窗: follow up (month 12)
The number of participants who withdraw during the follow-up period.
Change in executive function processing
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility
Change in short-term memory
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory
Change in brain volume
时间窗: baseline (Month 0), post-intervention (month 6)
Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan
Change in attention
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention
Change in cognitive flexibility
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility
Change in working memory
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory
Change in resting state functional connectivity
时间窗: baseline (Month 0), post-intervention (month 6)
Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence
Implementation
时间窗: post-intervention (month 6)
Percent of session checklist items completed as intended
Change in verbal memory
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory
Change in self-reported cognitive function
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function.
Reach
时间窗: baseline (Month 0)
Participation rate among eligible individuals contacted about the study.
Change in Cardiorespiratory Fitness
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.
Change in processing speed
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed
Change in inhibitory control
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in interference score on Stroop task, with positive values indicating greater inhibitory control.
Change in white matter integrity
时间窗: baseline (Month 0), post-intervention (month 6)
Change in fractional anisotropy as measured by diffusion MRI.
Change in Cancer-related Fatigue
时间窗: baseline (Month 0), post-intervention (month 6), follow up (month 12)
The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue.
次要结局
未报告次要终点
研究者
Diane K. Ehlers, Ph.D.
Principal Investigator
Mayo Clinic