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 乳腺癌治疗后有两个影响康复的主要因素。 为实现这一长期目标而采取的措施：(1) 乳腺癌幸存者获得康复的机会不足 解决 CRCI 的服务；(2) 支持有效干预措施的证据相对较少； 解决乳腺癌幸存者的 CRCI 该提案的总体假设是基于活动的。 元认知策略训练干预，日常职业表现的认知取向（CO- OP）方法，可以进行远程管理，以提高主观和客观的活动绩效 CRCI 乳腺癌幸存者的认知和生活质量 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将完成本研究的两个具体目标。 通过一项单盲、探索性、随机对照试验接受了乳腺癌治疗的患者。 将要求这些妇女完成过去三年内的化疗。 预筛选调查，以评估资格并确定他们是否患有 CRCI 那些自我报告的 CRCI 的人。 完成基线评估后，提供书面同意将接受基线评估。 电池，参与者（n = 44）将被随机分配到两组中的一组：（1）12节CO-OP干预；或 (2) 12 次注意力控制组 干预完成后，参与者将完成。 该 R03 的目的是获得对基线的评估。 治疗结果的效果和精确度将根据以下进行分析。 独立样本t检验和卡方检验将用于评估是否愿意对待模型。 随机化是成功的，报告的置信区间为 95%。 评估每项结果测量前后的可行性数据。 Cohen 的 d 效应大小以估计值（95% 置信区间）精确报告。 用于评估干预措施对小学和中学的组内和组间影响 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。本研究的预期结果将是：(1) 支持对该人群远程实施 CO-OP 的可行性的数据；以及 (2) 用于估计的数据； 与注意力对照组相比，CO-OP 的效果大小与研究结果一致。 国家医疗康复研究中心 (NCMRR) 的首要任务是识别、预防和治疗关键疾病 与残疾相关的次要疾病，例如癌症。