The Vulnerable Elders Survey Study of Older Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- Number of impaired domains on Comprehensive Geriatric Assessment (CGA)
研究概览
简要总结
RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.
详细描述
OBJECTIVES:
- Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.
- Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.
- Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.
- Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.
OUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
Patients are followed for 1 year for chemotherapy adherence and survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
干预措施: compliance monitoring (Behavioral)
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
干预措施: systemic chemotherapy (Drug)
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
干预措施: medical chart review (Other)
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
干预措施: study of socioeconomic and demographic variables (Other)
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
干预措施: survey administration (Other)
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
干预措施: cognitive assessment (Procedure)
Patients with cancer
Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.
干预措施: psychosocial assessment and care (Procedure)
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
干预措施: compliance monitoring (Behavioral)
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
干预措施: medical chart review (Other)
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
干预措施: study of socioeconomic and demographic variables (Other)
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
干预措施: survey administration (Other)
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
干预措施: cognitive assessment (Procedure)
Patients without cancer
non-cancer patients, seeking care at out-patient clinics
干预措施: psychosocial assessment and care (Procedure)
结局指标
主要结局
Number of impaired domains on Comprehensive Geriatric Assessment (CGA)
时间窗: at baseline and 12 months later.
Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities
时间窗: Patients are followed for 1 year for chemotherapy adherence and survival.
Vulnerable Elders Survey scores
时间窗: at baseline and 12 months later.
Functional decline
时间窗: at baseline and 12 months later.
Time to death
时间窗: Patients are followed for 1 year for chemotherapy adherence and survival.
次要结局
- Scores of individual battery of tools included in the CGA(at baseline and 12 months later)