PACCT: Partnering Around Cancer Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 2
- 主要终点
- Physician Offers of a Clinical Trial
研究概览
简要总结
This research has the overall goal of increasing rates at which African American and White men with prostate cancer make an informed decision to participate in a cancer clinical trial.
详细描述
This research utilizes two distinct research designs to evaluate two separate behavioral interventions.
The first is a between-subject randomized controlled trial to evaluate a patient-focused intervention. The intervention consists of a booklet designed to encourage patients to view themselves as part of the patient-physician team and to participate actively in clinical interactions by asking questions and stating concerns.
The second is a within-subject interrupted time series design to evaluate a physician-focused intervention. The intervention is an educational module and email reminders designed to encourage physicians to discuss trials with all eligible patients using patient-centered communication.In the patient-focused intervention, patients are randomized to an intervention or usual care group, and comparison of outcomes is made between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Physician participants
- •Inclusion criteria:
- •Treat patients with prostate cancer
- •Able to recruit patients to clinical trials
排除标准
- •Do not treat patients with prostate cancer
- •Not able to recruit patients to clinical trials
- •Patient Participants
- •Inclusion criteria:
- •Black, African American or White; Non-hispanic confirmed diagnosis of prostate Cancer
- •Seeing a participating physician for less than a year and expect to see this physician at least once in the coming year
- •Able to read and write English well enough to understand and sign consent forms and respond to questionnaires
- •Exclusion criteria:
- •Not black, African American or White; non Hispanic
- •No confirmed diagnosis of prostate cancer
- •Not seeing a participating physician or seeing a participating physician for > than one year
- •Not able to read and write English well enough to understand and sign consent forms and respond to questionnaires
研究组 & 干预措施
Patients--Intervention
Patients are randomized to an intervention group. They participate in all aspects of the study and also receive the intervention, which consists of a booklet.
干预措施: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams (Behavioral)
Patients--Usual Care
Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention.
Physicians
Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison
干预措施: Physicians: Educational Module (Behavioral)
结局指标
主要结局
Physician Offers of a Clinical Trial
时间窗: Day of clinical interaction; up to 2 years following enrollment
Single item: Did the physician offer a trial?
次要结局
- Patient Active Participation(Day of clinical interaction; up to 2 years following enrollment)
- Patient Decisions to Enroll in a Trial(1 week following clinical interaction)
- Quality of Informed Consent (Modified)(1 week following clinical interaction)
- Patient Enrollment in Trial(3 months following clinical interaction)
- Physician Patient-Centered Communication(Day of clinical interaction; up to 2 years following enrollment)
- Quality of Trial-Related Communication(Day of clinical interaction; up to 2 years following enrollment)
- Physician Patient-Centeredness(Immediately following clinical interaction)
研究者
Susan Eggly
Principal Investigator
Barbara Ann Karmanos Cancer Institute