CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Participant Retention Rate in CV CARE 2
研究概览
简要总结
This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.
The name of the intervention used in this research study is:
CV Care (cardiovascular risk assessment and management program)
详细描述
This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.
Study procedures including screening for eligibility, treatment visits, questionnaires and surveys, and blood and urine tests.
Participation in this research study is expected to last about 6 months.
It is expected that about 60-150 people will take part in this study.
This study is supported by the National Comprehensive Cancer Network (NCCN) through grant funding provided by Pfizer Myovant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.
- •Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.
- •Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.
- •Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.
- •Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.
- •Participants can have pre-existing CVD and/or CV risk factors, but this is not a requirement for inclusion.
- •Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.
- •Age ≥18 years.
- •Life expectancy of greater than 6 months.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.
- •Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.
- •Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.
- •Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.
研究组 & 干预措施
CV Care Program 2
Study procedures will be conducted as follows:
- Standard of care androgen deprivation therapy.
- 4 week standard-of-care follow up visit in clinic with CV care education module completion.
- 12-week standard-of-care prostate cancer care visit with oncologist.
- 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members.
- Participant feedback from surveys, exit-interviews, and possibly focus groups will be collected.
干预措施: CV Care Program (Behavioral)
CV Care Program
Study procedures will be conducted as follows:
- Standard of care androgen deprivation therapy.
- 4 week standard-of-care follow up visit in clinic with CV care education module completion.
- 12-week standard-of-care prostate cancer care visit with oncologist.
- 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members.
- The CV Care program will be revised through participant feedback from assessments, surveys, focus groups, and exit-interviews. The revised CV Care Program will be used in the next cohort.
干预措施: CV Care Program (Behavioral)
结局指标
主要结局
Participant Retention Rate in CV CARE 2
时间窗: Weeks 4 and 24 in CV CARE 2
The percentage of a continued participation rate at week 24 of participants who participate at week 4 in the revised iteration of the program (CV CARE 2).
次要结局
- Proportion of Participants on Statin Medications in CV CARE(5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit))
- Proportion of Participants on Statin Medications in CV CARE 2(5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit))
- Proportion of Participants on Blood Pressure Medications in CV CARE(5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit))
- Proportion of Participants on Blood Pressure Medications in CV CARE 2(5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit))
- Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE(6 months (From the ADT initiation to the week 24 on-treatment visit))
- Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE 2(6 months (From the ADT initiation to the week 24 on-treatment visit))
研究者
Alicia Morgans
Principal Investigator
Dana-Farber Cancer Institute