Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NRG Oncology
- 入组人数
- 550
- 试验地点
- 158
- 主要终点
- Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment
研究概览
简要总结
This trial studies how well increasing the dose of survivorship care planning improves care and outcomes in prostate cancer survivors receiving radiation therapy and androgen deprivation therapy. There is a need for coordinated care between the cancer care team with the primary care team. This is especially important for prostate cancer survivors who need routine cancer care follow-up with their radiation oncologist and also coordinated routine follow-up with their primary care provider (PCP). This is important because androgen deprivation therapy increases a patient's risk for developing diabetes, hypercholesterolemia, and cardiovascular events. Increasing the dose of survivorship may improve care and outcomes of cancer survivors than standard practices.
详细描述
PRIMARY OBJECTIVE:
I. To determine if the experimental arm (increased doses of survivorship care planning [SCP]) has more patients who saw a primary care provider and had blood glucose and cholesterol checked in year 2 (13-24 months) after finishing radiation therapy (RT) as compared to the control arm.
SECONDARY OBJECTIVES:
I. To determine if patients who receive increased doses of SCP have lower cardiovascular disease (CVD) risk score at 2 years as compared to patients who receive a one-time SCP.
II. To determine if patients who receive increased doses of SCP have improved patient reported coordination and satisfaction with care with respect to their primary care provider (PCP) or cardiologist as compared to patients who receive a one-time SCP and whether health literacy modifies the effect of SCP use on patient-reported coordination of care and satisfaction with care with respect to their PCP or cardiologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PRACTICE ELIGIBILITY CRITERIA
- •All institutions participating in a practice are NCORP components or sub-components
- •Have a mechanism for delivering SCPs to prostate cancer patients. Practices that currently provide SCPs are eligible but for this trial will need to use the study-provided SCP template.
- •See at least 10 patients meeting eligibility criteria per year.
- •Completion and submission of the NRG-CC007CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit [CTSU] website) by each practice to NRGCC007CD@nrgoncology.org).
- •Institutional Review Board (IRB) approval
- •Each principal investigator (PI) and research assistant (RA) at a NCORP practice must complete NRG-CC007CD SCP training. A training certificate will need to be completed and uploaded to the CTSU Regulatory Submission Portal. (See NRG-CC007CD Training Memo and Slides; located on the CTSU website). Note: staff and physicians cannot be part of multiple practices
- •For a practice that is participating on Wake Forest study, WF-1804CD is not able to participate in this trial in order to not impact the fidelity of either trial. As long as the clinicians (physicians, American Physician Partners [APPs]) are different for the patient populations of the two trials, a practice is eligible to participate in both trials
- •PATIENT ELIGIBILITY CRITERIA - PRIOR TO REGISTRATION (STEP 1)
- •The participant must be able to complete required questionnaires in English
- •The participant must have a diagnosis of prostate adenocarcinoma that will be treated with RT plus androgen deprivation therapy (ADT) with curative intent. Both definitive RT (intact prostate) and postprostatectomy RT patients are eligible
- •The ADT must be planned for at least 4 months and must include luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist
- •ADT may have started for no more than 120 days before registration
- •The participant must have a primary care provider and/or cardiologist or plan to obtain one
- •Comorbidities assessed at study entry using the Adult Comorbidity Evaluation (ACE)-27 instrument (located on the CTSU website)
- •The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
排除标准
- 未提供
结局指标
主要结局
Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment
时间窗: During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy.
A joint publication from the American Heart Association, American Cancer Society and American Urological Association made specific recommendations regarding cardiovascular follow-up for prostate cancer patients who receive androgen deprivation therapy (ADT) (Levine, 2010). Medical records from each participant's primary care physician (PCP) and cardiologist were reviewed to determine if a participant received care that followed the guideline recommendations interpreted in this study as meeting all three of the following criteria: * saw a primary care provider (PCP) or cardiologist * had fasting blood glucose checked * had fasting cholesterol check.
次要结局
- Calculated Cardiovascular (CVD) Risk Score at Two Years(Two years after completion of approximately 4-9 weeks of radiation therapy.)
- Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)(Two years after completion of approximately 4-9 weeks of radiation therapy.)
- Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)(Two years after completion of approximately 4-9 weeks of radiation therapy.)