A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 733
- 试验地点
- 45
- 主要终点
- Patient Experienced Any Grade 3-5 Toxicity
研究概览
简要总结
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine if providing information regarding geriatric assessment (GA) and GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients aged 70 and over with advanced cancer starting a new treatment regimen.
SECONDARY OBJECTIVES:
I. Proportion of patients who are alive at 6 months after study entry. II. Evaluate whether providing oncology physicians with information regarding GA summary and GA-driven recommendations influences clinical care of older patients receiving treatment for advanced cancer.
IIA. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •INCLUSION CRITERIA FOR PHYSICIANS
- •Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study
- •INCLUSION CRITERIA FOR PATIENTS
- •Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
- •Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and
排除标准
- •are met. *Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (>50%) will be allowed.
- •Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits
- •Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
- •Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit. If the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll.
- •Participant has adequate understanding of the English language
- •Exclusion Criteria:
- •EXCLUSION CRITERIA FOR PATIENTS
- •Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
- •Presence of symptomatic brain metastases at time of study consent process. Patients with a history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment.
结局指标
主要结局
Patient Experienced Any Grade 3-5 Toxicity
时间窗: 3 months
Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0.
次要结局
- Reduced Dose Intensity(4-6 weeks)
- GA-driven Recommendations Made Among Patients With Impaired Functional Status.(Baseline)
- GA-driven Recommendations Made Among Patients With Impaired Comorbidities.(Baseline)
- GA-driven Recommendations Made Among Patients With Impaired Psychological Status.(Baseline)
- Patient Survival at 6 Months(6 months)
- GA-driven Recommendations Made Among Patients With Impaired Nutrition.(Baseline)
- GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.(Baseline)
- GA-driven Recommendations Made Among Patients With Impaired Social Support.(Baseline)
- GA-driven Recommendations Made Among Patients With Impaired Physical Performance.(Baseline)
- GA-driven Recommendations Made Among Patients With Impaired Cognition.(Baseline)
研究者
Supriya Mohile
Professor
University of Rochester NCORP Research Base