LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to safely participate in outpatient rehabilitation.
- •Currently receiving rehabilitation.
- •Any participant who has urologic cancer or is enrolled in a competing trial.
研究组 & 干预措施
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.
干预措施: Occupational and Physical Therapy (Other)
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.
结局指标
主要结局
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
时间窗: 3 months
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.
次要结局
- To measure the change in Activities of Daily Living from Baseline and 2 months(2 months)
- To measure the change in Activities of Daily Living from Baseline and 3 months(3 months)
- To measure the change in physical health from Baseline and 2 months(2 months)
- To measure the change in cognitive function from Baseline and 3 months(3 months)
- To measure the change in quality of life from Baseline and 3 months(3 months)
- To measure the change in internalized occupational possibilities from Baseline and 2 months(2 months)
- To measure the change in quality of life from Baseline and 2 months(2 months)
- To measure the change in internalized occupational possibilities from Baseline and 3 months(3 months)
- To measure the change in upper extremity use and ability over the course of the study(3 months)
- To measure the change in cognition over the course of the study(3 months)
- To measure the change in physical health from Baseline and 3 months(3 months)
- To measure the change in cognitive function from Baseline and 2 months(2 months)
- To measure the feasibility of the CARE Program(3 months)
- To measure the change in balance over the course of the study(3 months)
- To measure the change in dynamic gait ability over the course of the study(3 months)
- To measure satisfaction with the CARE Program(3 months)