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。项目摘要/摘要 该项目的长期目标是帮助改善与癌症相关的认知障碍（CRCI）的恢复。 治疗乳腺癌。影响恢复的两个主要因素必须是 解决这个长期目标：（1）乳腺癌存活不足获得康复 解决CRCI的服务； （2）几乎没有证据支持有效干预措施 解决乳腺癌存活中的CRCI。该提议的总体假设是基于活动的 元认知 - 策略训练干预措施，每日职业表现的认知取向（共同） 操作方法，可以远程管理以提高活动性能，主观和客观 CRCI的乳腺癌存活中的认知和生活质量。这项研究的具体目的是：（1） 评估自我报告CRCI的乳腺癌存活的可行性； （2）到 评估合作社对活动表现，主观和客观认知以及生活质量的影响 自我报告CRCI的乳腺癌存活样本。这项研究的两个具体目标都将完成 通过单盲，探索性，随机对照试验。接受的乳腺癌患者 在过去三年中，化学疗法将被确定。这些女人将被要求完成 预筛选调查以评估资格并确定它们是否具有CRCI。那些有自我报告的CRCI的人 提供书面同意将接受基线评估电池。完成基线评估后 电池，参与者（n = 44）将被随机分为两组之一：（1）12个会话合作干预；或者 （2）一个12会议注意控制组。干预完成后，参与者将完成 基线时完成的相同评估电池。该R03的目的是获得估计值 反应的影响和精度对结果度量。治疗结果将在 打算治疗模型。独立样本t检验和卡方测试将用于评估是否是否 随机化成功。以95％置信区间报告的描述性统计数据将用于 评估可行性数据。每种结果指标的前后变化都将针对这两者进行计算 组。 Cohen的D效应大小在估计中的精度报道，置信区间为95％，将是 用于评估干预措施对初级和次级的群体效应 结果措施。最后，将开发使用Pearson相关系数的相关矩阵 评估结果度量之间的关系。这项研究的预期结果将是：（1） 数据以支持向该人群远程管理合作的可行性； （2）估计数据 与注意力控制组相比，合作社的效应大小。该提议与研究一致 国家医疗康复研究中心（NCMRR）的优先级，以识别，预防和治疗密钥 与残疾有关的次要条件，例如癌症。