Advancing Screening and Treatment for Older Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 10
- 主要终点
- Rate of grade 3-5 toxicity during chemotherapy
研究概览
简要总结
This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.
详细描述
PRIMARY OBJECTIVES:
I. To identify areas of vulnerability in older adults with cancer through the use of a geriatric assessment, and to identify the potential referrals to an interdisciplinary team based on geriatric assessment results.
II. To determine whether the geriatric assessment driven interventions will lead to decrease in grade 3-5 toxicity.
SECONDARY OBJECTIVES:
I. To determine whether the geriatric assessment driven interventions will lead to improvement in the following outcomes: unplanned hospitalization, average length of stay (ALOS), emergency visits, unplanned readmission rates, and advance directive completion.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a solid tumor malignancy (any stage)
- •Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed)
- •English, Spanish, and/or Chinese speaking
- •Able to provide written informed consent
排除标准
- •Not fluent in English, Spanish and/or Chinese (because not all questionnaires have been validated in other languages)
研究组 & 干预措施
Arm I (geriatric assessment-driven treatment)
Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.
干预措施: Questionnaire Administration (Other)
Arm I (geriatric assessment-driven treatment)
Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.
干预措施: Comprehensive Geriatric Assessment (Other)
Arm I (geriatric assessment-driven treatment)
Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.
干预措施: Quality-of-Life Assessment (Other)
Arm I (geriatric assessment-driven treatment)
Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.
干预措施: Survey Administration (Other)
Arm II (standard of care)
Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.
干预措施: Quality-of-Life Assessment (Other)
Arm II (standard of care)
Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.
干预措施: Questionnaire Administration (Other)
Arm II (standard of care)
Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.
干预措施: Survey Administration (Other)
结局指标
主要结局
Rate of grade 3-5 toxicity during chemotherapy
时间窗: Up to 6 months
Compared pre versus (vs) post-chemotherapy. Tested using general linear models with an alpha of 0.05.
次要结局
- Rate of hospitalizations during chemotherapy(Up to 6 months)
- Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living(Baseline to up to 6 months)
- Change in quality of life as measured by Functional Assessment of Cancer Therapy - General(Baseline to up to 6 months)