Mitigating Cancer-Related Cognitive Impairment in Older Adults With Breast Cancer Receiving Chemotherapy: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and test usability of the intervention.
详细描述
Cancer-related cognitive dysfunction (CRCD) is a significant problem, affecting up to 75% of patients receiving chemotherapy. Older adults are at greater risk of developing CRCD which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising tool that improves perceived cognition in younger cancer survivors with CRCD. For older adults with cancer, MAAT could be delivered alongside chemotherapy to mitigate the development of CRCD (when risk is highest) and CRCD-related effects on functional independence for older adults. However, MAAT will require adaptation to meet the unique needs of older adults to optimize usability and efficacy for this population. The overarching goal of this project is to adapt MAAT for older adults using input from patient and caregiver stakeholders (phase I), and subsequently gather data on the preliminary effects of the adapted MAAT (MAAT-Geriatrics [G]) on perceived cognition, objective cognitive measures and functional independence. The provided details pertain to Phase I of the study, which will focus on the adaptation process and usability testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of invasive breast cancer
- •Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for breast cancer with two additional cycles remaining.
- •Be age 65 or older
- •Able to provide informed consent
- •Able to read and understand English (or possess a designated health care proxy that can do the same that was designated prior to the patient losing decision-making capabilities)
排除标准
- •Have surgery planned within 3 months of consent
- •Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent
- •Patients with breast cancer receiving endocrine therapy as their only systemic therapy will not be eligible.
- •Eligible Caregiver Inclusion Criteria:
- •Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 21 or older] with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
- •Eligible Caregiver Exclusion Criteria:
- •Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded
结局指标
主要结局
System Usability Scale (SUS)
时间窗: Post-Intervention (up to 2 weeks)
The System Usability Scale is a metric to evaluate the usability of the intervention (Patients) and is scored 0 (minimum) to 100 (maximum). Higher scores indicate greater usability. A mean score \>68 is consisted with optimal usability.
Experience Interview
时间窗: Post-Intervention (up to 2 weeks)
Semi-structured interview with patients and caregivers about experience with MAAT-G. (Patients and caregivers) Qualitative Analysis of transcripts from participant/caregiver interviews will be analyzed for themes on intervention benefit and barriers and facilitators.
次要结局
未报告次要终点
研究者
Allison Magnuson
Associate Professor of Medicine
University of Rochester