Breaking Through the Brain Fog: An Online RCT for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- BrainHealth Index Score
研究概览
简要总结
This study will investigate the benefits of distinct brain health trainings in breast cancer survivors (age 30-80) with cognitive concerns post-chemotherapy. This study can be completed from the comfort of participant's own home.
详细描述
Participants will complete online assessments at 3 timepoints over 6 months (Month 0, 3, 6). During the first 3 months of the study, participants will be randomized into one of three online training programs to support cognitive function; training will end after the first 3 months. The third online assessment (Month 6) will measure maintained gains since ending training. Participants will not be aware of the interventions assigned to other participants. Participants may be reimbursed for their time.
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
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer survivors who...
- •are between ages of 30-80
- •were diagnosed with Stage I-III
- •received chemotherapy
- •completed chemotherapy at least 6 months ago but not more than 5 years
- •endorse changes in thinking since end of chemotherapy treatment
- •have working internet and a device
- •consider themselves fluent in English
- •Exclusion criteria:
- •A re-occurrence of breast cancer or a diagnosis of another
- •An uncorrected hearing or vision issue that would hinder ability to read and/or listen to training material
- •Participation in a cognitive training program in the last 12 months.
- •A reported substance abuse problem
- •Diagnosis of a neurodegenerative disease or psychotic disorder
- •History of stroke, concussion, or brain injury since completing chemotherapy
- •Inability to function independently due to Autism Spectrum Disorder diagnosis
排除标准
- 未提供
结局指标
主要结局
BrainHealth Index Score
时间窗: Baseline, 3 month, 6 month
The investigators will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index across multiple timepoints. (Min value = 16, Max value = 1032) (Higher score = Better outcome)
次要结局
- Delayed matching to sample(Baseline, 3 month, 6 month)
- Double Decision(Baseline, 3 month, 6 month)
- Rapid Visual Information Processing(Baseline, 3 month, 6 month)
- Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)(Baseline, 3 month, 6 month)
研究者
Sandra Chapman, PhD
Professor
The University of Texas at Dallas