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临床试验/NCT05505045
NCT05505045已完成不适用

Feasibility of Using Remotely-delivered Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Telehealth Usability Questionnaire (TUQ)

研究概览

简要总结

The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. The second aim of this study is 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. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to attention control, on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI.

详细描述

Breast cancer survivors often self-report cognitive changes after treatment for cancer (e.g. cancer-related cognitive impairment (CRCI)). These cognitive changes have a devastating impact on everyday life activities, such as work/productivity, community involvement, driving, and financial management. While CRCI would likely be amenable to rehabilitation services, breast cancer survivors face two primary barriers to adequate rehabilitation, including (1) inadequate access to rehabilitation services, and (2) limited effective interventions to address CRCI.

Breast cancer survivors have inadequate access to rehabilitation services to address CRCI. A recent report sponsored by the National Cancer Institute (NCI) concluded that most NCI-designated cancer centers do not have integrated cancer rehabilitation services. Even if comprehensive rehabilitation services were provided by these centers, millions of cancer survivors live in rural areas outside close proximity to a cancer center and are more likely to experience poorer outcomes compared to urban counterparts. If rehabilitation services were provided, proximity to facilities may be a limiting factor in individuals from rural communities receiving rehabilitative care. Access to services has been further curtailed amid the COVID-19 pandemic, with calls building from national organizations for improvements in remote delivery of services.

Metacognitive strategy training (MCST) is a practice standard to address cognitive impairment in other conditions, such as traumatic brain injury and stroke. The Cognitive-Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. The investigators' preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, and quality of life in breast cancer survivors with CRCI. While current evidence supports the remote delivery of strategy-based interventions like CO-OP, this intervention has not been evaluated in breast cancer survivors with CRCI.

The investigators' overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognition, and subjective quality of life in breast cancer survivors with CRCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

All outcomes assessors will be blinded to participant study group assignment.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • self-reported CRCI (Cognitive Failures Questionnaire (CFQ) score >30)
  • completed full course of chemotherapy at least 6 months, but no later than 3 years, prior to participation
  • able to read, write, and speak English fluently
  • able to provide valid informed consent
  • have a life expectancy of greater than 6 months at time of enrollment
  • diagnosed with breast cancer (invasive ductal or lobular BrCA Stages I, II, or III) and completed chemotherapy within the preceding three years
  • on stable doses of medications (i.e., no changes in past 60 days)

排除标准

  • prior cancer diagnoses of other sites with evidence of active disease within the past year
  • active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain function (e.g., Parkinson's disease, dementia, cerebral infarcts, traumatic brain injury)
  • severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21)

结局指标

主要结局

Telehealth Usability Questionnaire (TUQ)

时间窗: After study completion, an average of 14 weeks

Measure of telehealth usability from participant's perspective. Specifically, the TUQ measures usefulness and utility of technologies including usefulness, ease of use, effectiveness, reliability, and satisfaction. The TUQ uses a self-report Likert scale of 1 (disagree) to 7 (agree).

Acceptability of Intervention Measure (AIM)

时间窗: After study completion, an average of 14 weeks

Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Feasibility of Intervention Measure (FIM)

时间窗: After study completion, an average of 14 weeks

Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Intervention Appropriateness Measure (IAM)

时间窗: After study completion, an average of 14 weeks

Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction

时间窗: After study completion, an average of 14 weeks

Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.

Canadian Occupational Performance Measure (COPM) Trained Goal Performance

时间窗: Pre-intervention (week 0) and post-intervention (week 14)

Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

NeuroQoL Cognitive Function Short Form

时间窗: Pre-intervention (week 0) and post-intervention (week 14)

Self-report measure of cognitive ability in daily life activity. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). The total raw score range is 8-40. The t-score is reported with a mean of 50 and standard deviation of 10. Higher scores mean fewer perceived cognitive challenges.

次要结局

  • Functional Assessment of Cancer Therapy-Breast (FACT-B)(Pre-intervention (week 0) and post-intervention (week 14))
  • Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest(Pre-intervention (week 0) and post-intervention (week 14))
  • Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest(Pre-intervention (week 0) and post-intervention (week 14))
  • Brief Visuospatial Memory Test -Revised Trial 1(Pre-intervention (week 0) and post-intervention (week 14))
  • Paced Auditory Serial Addition Test(Pre-intervention (week 0) and post-intervention (week 14))
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities(Pre-intervention (week 0) and post-intervention (week 14))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Boone

Assistant Professor

University of Missouri-Columbia

研究点 (2)

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