MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months]
研究概览
简要总结
This randomized clinical trial studies collaborative targeted case management in improving functional status in patients with stage III-IV cancer. Collaborative targeted case management may improve functional mobility, improve quality of life, and reduce pain and health care utilization in patients with advanced cancer
详细描述
PRIMARY OBJECTIVES:
I. Establish the comparative effectiveness of the Collaborative Care to Preserve Performance in Cancer (COPE) trial arms in preserving functional mobility.
II. To assess the comparative cost-effectiveness and cost-utility of the COPE interventions.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage III or stage IV cancer
- •Life expectancy > 6 months
- •Ambulatory Post Acute Care (APC) score between 53 and 66
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed written consent
- •Have working phone to communicate with study team
- •Fluent in English
- •Sufficient auditory acuity
- •Intact cognitive status
排除标准
- •Patient is within 2 months of a major surgical procedure
研究组 & 干预措施
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: telephone-based intervention (Behavioral)
Arm I (enhanced usual care)
Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
干预措施: telephone-based intervention (Behavioral)
Arm I (enhanced usual care)
Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
干预措施: questionnaire administration (Other)
Arm I (enhanced usual care)
Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
干预措施: quality-of-life assessment (Procedure)
Arm I (enhanced usual care)
Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
干预措施: management of therapy complications (Procedure)
Arm I (enhanced usual care)
Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
干预措施: assessment of therapy complications (Procedure)
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: case management (Other)
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: physical therapy (Procedure)
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: questionnaire administration (Other)
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: quality-of-life assessment (Procedure)
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: educational intervention (Other)
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: management of therapy complications (Procedure)
Arm II (enhanced usual care, RCM)
Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
干预措施: assessment of therapy complications (Procedure)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: telephone-based intervention (Behavioral)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: case management (Other)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: management of therapy complications (Procedure)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: physical therapy (Procedure)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: questionnaire administration (Other)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: quality-of-life assessment (Procedure)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: educational intervention (Other)
Arm III (enhanced usual, RCM, PCM)
Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
干预措施: assessment of therapy complications (Procedure)
结局指标
主要结局
Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months]
时间窗: From baseline to 6 months
The mean change in the Ambulatory Post-Acute Care Basic Mobility Computer Adaptive Test (AM PAC CAT) score (month 6 minus baseline) and the \[95% confidence interval\] for patients assigned to each arm regardless of compliance are reported below. The AM PAC CAT is an item response theory-modeled scale that ranges from 0 to infinity. However, the score range of interest for the trial that corresponds to the ability to ambulate and transfer safely and independently (+/- gait aid) is 55 - 66 with higher scores corresponding to better mobility and the MID for improvement being 1.0. For the primary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
次要结局
- Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months].(From baseline to 6 months)
- Hospitalization frequency(From registration to 6 months)
- Discharge location from hospital(From registration to 6 months)
- Hospital length of stay(From registration to 6 months)
- Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline(From baseline to 6 months)
- Planned admission(From registration to 6 months)