Tailored Geriatric Assessment and Promotores Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Describe the percentage of participants that complete 2 out of 3 study visits
研究概览
简要总结
The goal of this clinical trial is to test a new way to help older adults who have had cancer.
The researchers want to see if a program that assesses participants health and aging is achievable and makes a difference. A community health worker/promotora de salud will assess their health and provide coaching to help them feel better. This is important because older adults with cancer often have other health issues that are not addressed after completing treatment. The researchers want to make sure they get the care they need.
详细描述
The proposed study is a single arm feasibility study of a supportive care intervention. Phase is not applicable because this is not a drug trial. The study involves enrolling older adult non-metastatic cancer survivors between 1 month and 24 months after the completion of any definitive (e.g., curative intent) cancer treatment. The objective is to determine if a Community Health Worker (CHW)-led geriatric assessment and coaching intervention to assess geriatric syndromes is a feasible modality in community-dwelling older adult cancer survivors. The tailored assessment intervention (geriatric assessment and coaching) is hypothesized to potentially be a feasible process to monitor patients that would otherwise not access geriatric services after completing cancer treatment. Coping and social support are hypothesized mediators to the relationship between physical function and health outcomes (e.g., physical function, mental health), influenced by sociodemographic contextual factors. Implementation science concepts, such as acceptability and scalability will also be collected. The study CHW will perform the geriatric assessment and coaching components with each of the patients in the study. The assessment component of the bundle intervention involves screening for frailty and cognition, occurring prior to the coaching session. The CHW will conduct a more thorough geriatric assessment for polypharmacy, depression, symptom burden, and social support. In follow up visits after the geriatric assessment the CHW will deliver the coaching component (derived from the Problem Solving Coaching Model) to participants. Each of the intervention sessions will consist of 45-minute appointments with tailored feedback of the geriatric assessment domains, caregiver and family support, and navigation to additional palliative care resources at the study institution. The researchers developed the content in the tailored assessment intervention from preliminary work and thorough review of scientific literature.
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 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Diagnosis of Stage II-III breast, colorectal, or prostate cancer in within 1 to 24 months.
- •Completed course of definitive therapy within 12 months from enrollment into the study.
- •Proficient in English or Spanish
- •Reside within the UC Davis Health catchment area.
- •Has self-reported primary caregiver aged 21-90 years.
排除标准
- •Contraindication to any study-related procedure or assessment.
- •Patient is unable to independently deliver informed consent.
- •Patient screens positive for cognitive impairment (6CIT > 8)
结局指标
主要结局
Describe the percentage of participants that complete 2 out of 3 study visits
时间窗: 6 month
Calculate percentage of participants that complete study compared to total enrolled (Goal: 65)
次要结局
- Self-Efficacy(Baseline to 6 month)
- Physical Function(Baseline to 6 month)
- Depression, Anxiety, and Fatigue(Baseline to 6 month)
- Quality of Life in Elderly Cancer Patients(Baseline to 6 month)
- Emotional Support(Baseline to 6 month)