Evaluating Cognitive Trajectories in Older Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
The majority of cancer diagnoses occur in adults age 65 years and over. This population is also rapidly expanding. There is a growing need for increased understanding about the potential impact of various newer therapies on common geriatric impairments in this group.
The aim of this study is to examine how feasible it is to carry out a study of cognitive function in older adults (age 65+) who are newly commencing anti-cancer treatments, specifically 'immune checkpoint inhibitor' therapy, over time. Participants in the study undergo four tests of memory and concentration every six weeks for a six month period. Additionally, the researcher will gather information about the participants' non-cancer therapy medications, physical and psychological symptoms, day to day functioning and any changes to these factors over time.
The purpose of the study is to examine a) recruitment, retention and engagement of participants to study procedures; b) to gather preliminary information about cognitive function in older adults commencing immune checkpoint inhibitor treatments and potential associations with cognitive decline over time.
详细描述
Despite cognitive concerns being commonly described by many patients with cancer, the majority of literature focuses on the impact of chemotherapy and more recently, hormone therapies, on cognitive function. Immune checkpoint inhibitors have revolutionised the management of many cancer types, and their indications are continuing to expand. There is insufficient evidence in the literature regarding the impact of therapy on cognitive function, and particularly in older adult age groups, who may be more susceptible to the cognitive effects of treatments.
Research Hypothesis:
A significant proportion of older adults receiving ICIs have cognitive impairment at the time of cancer diagnosis and that cognition deteriorates in this cohort of adults over the course of their illness due to many factors.
Aim:
To evaluate trajectories of cognitive decline in older adults with cancer commencing ICI therapy over time and to examine associated factors which may influence the trajectory of cognitive decline in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 65 years and over
- •Newly commencing immune checkpoint inhibitor therapy (either monotherapy, dual therapy or in combination with other anti-cancer therapies)
排除标准
- •Unable to complete/engage in study assessment procedures
- •Unable to provide informed consent
- •Previous ICI therapy
研究组 & 干预措施
Participant Group
Older adults (age 65 years and over) newly commencing immune checkpoint inhibitor therapy for cancer
结局指标
主要结局
Recruitment
时间窗: From recruitment start date (May 2024) to recruitment end date (December 2025) (18 months)
25% of those given a Patient Information Leaflet during the recruitment period (18 months i.e. from May 2024 to December 2025) consent to the study procedures and enter the study
Retention
时间窗: 3 months from individual participant study commencement date
50% who are still on treatment complete the 3-month assessment (primary endpoint)
Adherence/Engagement
时间窗: 3 months from individual participant study start date
75% of cognitive tests are completed up to and including the 3-month timepoint
Adherence/Engagement
时间窗: 3 months from individual study participant start date
75% of assessments are completed within 10 days of the 6-weekly timepoint
次要结局
未报告次要终点
研究者
Prof Andrew Davies
Professor of Palliative Medicine
Our Lady's Hospice and Care Services