Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
概览
- 阶段
- 不适用
- 干预措施
- Metacognitive Strategy Training (MCST)
- 疾病 / 适应症
- Breast Cancer Female
- 发起方
- University of Missouri-Columbia
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility measures
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.
详细描述
Breast cancer survivors often self-report cognitive deficits, primarily in executive functioning (planning, problem solving, multitasking), memory, and processing speed after cancer treatment, i.e., cancer-related cognitive impairment (CRCI). The prevalence of CRCI following breast cancer is as high as 78% and can persist chronically after treatment has ended. In other health conditions associated with cognitive impairment, such as traumatic brain injury, the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training (MCST). In this approach, participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity. While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST, there is no study in the published literature which measures the efficacy of MCST on CRCI. 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. Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI. Further, this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods.
研究者
Anna Boone
Assistant Professor
University of Missouri-Columbia
入排标准
入选标准
- •self-reported CRCI (Global Rating of Cognition dysfunction as "Moderately" "Strongly "or "Extremely" AND a Cognitive Failures Questionnaire1 (CFQ) score \>30)
- •completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater 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
- •on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)
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 anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of \<23 on the Montreal Cognitive Assessment (MoCA)
- •severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)
- •history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)
- •conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)
- •blue-yellow colorblindness
- •pregnancy
- •The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria will be used to verify appropriate selection of study participants.
研究组 & 干预措施
Metacognitive strategy training (MCST)
Each MCST session will be follow the procedures of Cognitive Orientation to daily Occupational Performance (CO-OP) intervention. There will be 10, 45-minute, weekly sessions. All sessions will be delivered in-person with a trained occupational therapist.
干预措施: Metacognitive Strategy Training (MCST)
Inactive Control Group
Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.
干预措施: Inactive Control Group
结局指标
主要结局
Feasibility measures
时间窗: After study completion, an average of 12 weeks
Recruitment rate, retention rate
Canadian Occupational Performance Measure (COPM) Performance
时间窗: Pre-intervention (week 0) and post-intervention (week 12)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Canadian Occupational Performance Measure (COPM) Satisfaction
时间窗: Pre-intervention (week 0) and post-intervention (week 12)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
次要结局
- Paced Auditory Serial Addition Test (PASAT)(Pre-intervention (week 0) and post-intervention (week 12))
- Trail Making Test (TMT)(Pre-intervention (week 0) and post-intervention (week 12))
- Functional Assessment of Cancer Therapy-Breast (FACT-B)(Pre-intervention (week 0) and post-intervention (week 12))
- Hopkins Verbal Learning Test-Revised (HVLT-R)(Pre-intervention (week 0) and post-intervention (week 12))
- Cognitive Failures Questionnaire (CFQ)(Pre-intervention (week 0) and post-intervention (week 12))
- Dysexecutive Questionnaire (DEX)(Pre-intervention (week 0) and post-intervention (week 12))
- Controlled Oral Word Association (COWA)(Pre-intervention (week 0) and post-intervention (week 12))
- The Activity Card Sort (ACS)(Pre-intervention (week 0) and post-intervention (week 12))
- Participation Strategies Self Efficacy Scale (PS-SES)(Pre-intervention (week 0) and post-intervention (week 12))