Feasibility of using remotely-delivered metacognitive strategy training to address cancer-related cognitive impairment in breast cancer

使用远程元认知策略培训来解决乳腺癌中与癌症相关的认知障碍的可行性

• 批准号: 10652969
• 负责人: Anna Boone
• 金额: $ 15.65万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10652969
• 关键词: Achievement; Activities of Daily Living; Address; Aftercare; Automobile Driving; Breast Cancer Patient; Breast Cancer Treatment; Breast Cancer survivor; COVID-19 pandemic; Cancer Center; Cancer Survivor; Chi-Square Tests; Chronic; Cognition; Cognitive; Cognitive deficits; Confidence Intervals; Consent; Control Groups; Data; Educational Intervention; Educational process of instructing; Eligibility Determination; Feasibility Studies; Foundations; Future; Goals; Health; Health Services Accessibility; Hour; Impaired cognition; Individual; Informed Consent; Intention; Intervention; Intervention Studies; Knowledge; Malignant Neoplasms; Medical center; Memory; Meta-Analysis; Modeling; National Cancer Institute; Occupational; Occupational Therapy; Occupational activity of managing finances; Outcome; Outcome Measure; Outcome Study; Participant; Patient Self-Report; Performance; Population; Preparation; Prevalence; Problem Solving; Productivity; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Recovery; Reporting; Research; Research Priority; Rural Community; Rural Population; Sample Size; Sampling; Single-Blind Study; Stroke; Surveys; Symptoms; Testing; Training; Traumatic Brain Injury; Treatment outcome; Woman; Work; Writing; attentional control; cancer rehabilitation; cancer therapy; cancer-related cognitive impairment; chemotherapy; cognitive change; cognitive performance; community involvement; disability; effective intervention; executive function; experience; improved; improved outcome; innovation; intervention effect; malignant breast neoplasm; multitask; novel; post intervention; prevent; primary outcome; recruit; rehabilitation research; rehabilitation service; rehabilitative care; remote administration; remote delivery; response; rural area; screening; secondary outcome; service delivery; service intervention; skills; statistics; treatment group

7. Project Summary/Abstract The long-term goal of this project is to help improve recovery from cancer-related cognitive impairment (CRCI) following treatment for breast cancer. There are two primary factors impacting recovery that must be addressed to achieve this long-term goal: (1) breast cancer survivors have inadequate access to rehabilitation services to address CRCI; and (2) there is relatively little evidence supporting effective interventions that address CRCI in breast cancer survivors. The overall hypothesis of this proposal is that an activity-based metacognitive-strategy training intervention, the Cognitive Orientation to daily Occupational Performance (CO- OP) approach, can feasibly be administered remotely to improve activity performance, subjective and objective cognition, and quality of life in breast cancer survivors with CRCI. The specific aims of this study are: (1) to assess the feasibility of delivering CO-OP remotely to breast cancer survivors who self-report CRCI; and (2) to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI. Both specific aims of this study will be completed through a single-blind, exploratory, randomized controlled trial. Breast cancer patients who received chemotherapy within the past three years will be identified. These women will be asked to complete a prescreening survey to evaluate eligibility and identify if they have CRCI. Those with self-reported CRCI who provide written consent will undergo a baseline assessment battery. After completing the baseline assessment battery, participants (n=44) will be randomized to one of two groups: (1) a 12 session CO-OP intervention; or (2) a 12 session attention control group. Following the completion of the intervention, participants will complete the same assessment battery that was completed at baseline. The purpose of this R03 is to obtain estimates of effect and precision of response on the outcome measures. Treatment outcomes will be analyzed under the intention to treat model. Independent samples t-test and chi square test will be used to evaluate whether randomization was successful. Descriptive statistics, reported with 95% confidence intervals, will be used to evaluate the feasibility data. Pre-to-post change in each of the outcome measures will be calculated for both groups. Cohen’s d effect size reported with precision around the estimate, 95% confidence intervals, will be used to evaluate the within and between group effects of the interventions on the primary and secondary outcome measures. Finally, a correlation matrix using Pearson correlation coefficients will be developed to evaluate the relationships between the outcome measures. The expected outcomes of this study will be: (1) data to support the feasibility of remotely administering CO-OP to this population; and (2) data to estimate effect sizes of CO-OP compared to the attention control group. This proposal is consistent with the research priority of the National Center for Medical Rehabilitation Research (NCMRR) to identify, prevent, and treat key secondary conditions associated with disabilities, e.g., cancer.

7.项目总结/摘要 该项目的长期目标是帮助改善癌症相关认知障碍（CRCI）的恢复 在乳腺癌治疗后。有两个主要因素影响复苏，必须 为实现这一长期目标，需要解决以下问题：（1）乳腺癌幸存者无法充分获得康复服务 （2）没有足够的证据支持有效的干预措施， 解决乳腺癌幸存者的CRCI问题。这一建议的总体假设是， 元认知策略训练干预，认知取向日常职业绩效（CO- OP）方法，可以可行地远程管理，以改善主观和客观的活动表现 认知和CRCI乳腺癌幸存者的生活质量。本研究的具体目的是：（1） 评估向自我报告CRCI的乳腺癌幸存者远程提供CO-OP的可行性;以及（2） 评估CO-OP对活动表现、主观和客观认知以及生活质量的影响， 自我报告CRCI的乳腺癌幸存者样本。本研究的两个具体目标将在 通过单盲、探索性、随机对照试验。乳腺癌患者接受 在过去的三年里，化疗将被确定。这些妇女将被要求完成一项 预筛选调查，以评估合格性并确定他们是否患有CRCI。自我报告的CRCI患者， 提供书面同意将进行基线评估电池。完成基线评估后 组合，参与者（n = 44）将被随机分配到两组之一：（1）12次CO-OP干预;或 (2)一个12个疗程的注意力控制组。完成干预后，参与者将完成 与基线时完成的评估组合相同。本R03的目的是获得 对结果测量的响应的效果和精确度。治疗结果将根据 意向治疗模式。独立样本t检验和卡方检验将用于评估是否 随机化成功。将使用描述性统计量（报告95%置信区间）， 评估可行性数据。将计算两项结局指标的前后变化 组Cohen's d效应量报告的精确度在估计值附近，95%置信区间，将是 用于评估干预措施对初级和次级的组内和组间影响 结果测量。最后，将开发使用皮尔逊相关系数的相关矩阵， 评估结果测量之间的关系。本研究的预期结果为：（1） 支持对该人群远程管理CO-OP可行性的数据;以及（2）估计 与注意力控制组相比，CO-OP的效应量。这一建议与研究一致 国家医疗康复研究中心（NCMRR）的优先事项，以确定，预防和治疗关键 与残疾相关的次要条件，例如，癌