The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)
2017年9月11日 更新者：UNC Lineberger Comprehensive Cancer Center
LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.
研究概览
详细说明
This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer.
Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility.
Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers.
Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only).
Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups.
We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.
研究类型
介入性
注册 (实际的)
67
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Aged 65 years or older
- Has an outpatient appointment within UNC Chapel Hill Lineberger Comprehensive Cancer Center
- Diagnosis of cancer within last two years.
- Has a life expectancy of 12 months or longer. All cancer types are included.
- English speaking
- Willing to complete the UNC GA
- Has at least one functional deficit as defined by GA screen
- Understands study design, risks, and benefits and have signed informed consent
- Willing to be randomized into either study arm
- Ability to safely participate in outpatient rehabilitation program
Exclusion Criteria:
- Unable to safely participate in outpatient rehabilitation.
- Currently receiving rehabilitation.
- Any participant who has urologic cancer or is enrolled in a competing trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CARE Intervention
This group will be contacted to make an appointment for outpatient Occupational and Physical therapy.
The therapist will determine the type, frequency and length of treatment.
Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed.
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OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
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无干预：CARE Control
Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program.
The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
大体时间：3 months
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Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To measure the change in Activities of Daily Living from Baseline and 2 months
大体时间：2 months
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As measured by the Geriatric Assessment
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2 months
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To measure the change in Activities of Daily Living from Baseline and 3 months
大体时间：3 months
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As measured by the Geriatric Assessment
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3 months
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To measure the change in physical health from Baseline and 3 months
大体时间：3 months
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As measured by the Geriatric Assessment
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3 months
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To measure the change in physical health from Baseline and 2 months
大体时间：2 months
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As measured by the Geriatric Assessment
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2 months
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To measure the change in quality of life from Baseline and 2 months
大体时间：2 months
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As measured by the PROMIS assessment
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2 months
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To measure the change in quality of life from Baseline and 3 months
大体时间：3 months
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As measured by the PROMIS assessment
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3 months
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To measure the change in internalized occupational possibilities from Baseline and 3 months
大体时间：3 months
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As measured by the Possibilities for Activity Scale (PActS)
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3 months
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To measure the change in internalized occupational possibilities from Baseline and 2 months
大体时间：2 months
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As measured by the Possibilities for Activity Scale (PActS)
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2 months
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To measure the change in cognitive function from Baseline and 2 months
大体时间：2 months
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As measured by the Blessed Memory Orientation Concentration test
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2 months
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To measure the change in cognitive function from Baseline and 3 months
大体时间：3 months
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As measured by the Blessed Memory Orientation Concentration test
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3 months
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To measure the feasibility of the CARE Program
大体时间：3 months
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To describe the feasibility of the CARE program by reporting enrollment and retention as defined by (1) percent eligible who agree to participate (2) percent in each group that completed follow-up measures at 2 and 3 months and (3) percent of patients in CARE program who go to 70% of appointments.
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3 months
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To measure the change in balance over the course of the study
大体时间：3 months
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Intervention Group Only: As measured by the Berg Balance Scale
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3 months
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To measure the change in upper extremity use and ability over the course of the study
大体时间：3 months
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Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale
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3 months
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To measure the change in cognition over the course of the study
大体时间：3 months
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Intervention Group Only: As measured by the Montreal Cognitive Assessment
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3 months
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To measure the change in dynamic gait ability over the course of the study
大体时间：3 months
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Intervention Group Only: As measured by the Dynamic Gait Index
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3 months
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To measure satisfaction with the CARE Program
大体时间：3 months
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To evaluate the program a short interview will be completed with CARE team to determine what worked well, what didn't and suggested changes/improvements for CARE program after completion of project.
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mackenzi Pergolotti, PhD、Colorado State University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年6月1日
初级完成 (实际的)
2017年3月1日
研究完成 (实际的)
2017年3月1日
研究注册日期
首次提交
2014年12月1日
首先提交符合 QC 标准的
2014年12月2日
首次发布 (估计)
2014年12月3日
研究记录更新
最后更新发布 (实际的)
2017年9月12日
上次提交的符合 QC 标准的更新
2017年9月11日
最后验证
2017年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.