A Pilot Study of a Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Chemotherapy Toxicity
研究概览
简要总结
The purpose of this study is to determine whether information regarding GA and GA-driven interventions improves outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment in patients with and without GA-driven interventions. The investigators will identify information that will be useful based on questionnaire responses and blood tests. These results will be used to better understand which recommendations and interventions will benefit older cancer patients. It is our hope that these tools, which are well-established at identifying areas of risk, will provide meaningful opportunities for intervention to promote your safety during cancer management. The investigators will be able to use this information to teach others on how to best care for adults aged 70 and older with cancer.
详细描述
Although cancer is very common in older patients, the optimal treatment for cancer for this subset of patients is not well established. As a result of lack of knowledge on the safety and efficacy of chemotherapy in older adults, a significant proportion of older patients receiving chemotherapy have toxicity. There is also little information regarding how to best make decisions for and implement interventions to improve outcomes of older patients with cancer who are to receive treatment. Additionally, there is marked heterogeneity in the geriatric population, and patients of similar chronologic age may have wide disparity in their overall health status. Geriatricians utilize a tool called the Geriatric Assessment (GA) to gauge an older patient's overall health status and identify potential areas of deficits. The GA is a comprehensive tool, incorporating the assessment of physical function, co-morbid conditions, social support, nutritional, psychological, and cognitive status and medication review. A small number of studies in the oncology literature have demonstrated the value of GA in guiding cancer-directed treatment plans for older patients. GA can identify potential areas of deficits in an older patient's overall health status that have been shown to predict chemotherapy toxicity and guide interventions to improve outcomes for older patients. Studies of interventions in community-dwelling older adults have demonstrated efficacy at improving deficits identified on GA. However, in older patients with cancer, there is currently limited data regarding how GA can affect decision-making for treatment and impact overall clinical care.
In a two-arm, randomized pilot study, we will evaluate the effect of GA and GA-driven interventions on the outcomes of older cancer patients receiving first-line or second-line chemotherapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of solid tumor malignancy or lymphoma
- •Have advanced cancer
- •Have received a recommendation for first or second line treatment with chemotherapy by their primary oncologist. Treatment regimens may include chemotherapy, chemoradiotherapy, targeted agents or monoclonal antibody.
- •Planned chemotherapy for at least 3 months
- •Be age 70 or older
- •Have a live expectancy with treatment of 6 months or greater
- •Able to provide informed consent or, if the physician deems the patient to not have decision-making capacity, a patient-designated health care proxy (that was pre-existing; prior to the patient losing decision-making capacity) must sign consent per institutional (University of Rochester and Research Subject Review Board) policies on consent for incapacitated/decisionally impaired subjects164,165
- •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
- •Have a planned referral to the geriatric oncology clinic within one month of treatment initiation
- •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
研究组 & 干预措施
Control Arm
Control Arm = Standard of Care. Patients who are randomized to the control arm will only have abnormal results on Geriatric Depression Scale (GDS) and cognitive evaluation communicated to their primary oncologist, as is customary. These results will be communicated to the primary team via electronic medical record and/or email communication. No other summary will be provided to oncologist.
Treatment Arm
Treatment Arm = Standard care plus GA results and recommendations. For patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic (GA-driven intervention). The intervention consists of providing results of geriatric assessment in a summary to oncologists.
干预措施: GA-driven Intervention (Other)
结局指标
主要结局
Chemotherapy Toxicity
时间窗: Over 3 months
The primary outcome measure for this study is to determine if GA-driven interventions improve outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment. The primary analysis will be a comparison of the proportion of patients who developed grade \>3 toxicity over 3 months time using the likelihood ratio test.
次要结局
未报告次要终点
研究者
Supriya Mohile
Supriya Gupta Mohile, M.D., M.S. - Associate Professor of Medicine at the James Wilmot Cancer Center at the University of Rochester. Director, Geriatric Oncology Clinic.
University of Rochester