Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Percentage of patients that enroll to early phase cancer treatment clinical trials.
研究概览
简要总结
This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).
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
- Single (Participant)
盲法说明
Patient participants will not be informed of which intervention they are assigned.
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
- •for Patient Subjects:
- •Aged 18 years or older
- •Self-described African American race (patients who self-describe as "more than one race" will be included)
- •Scheduled for new or consult oncology appointment at the study site
- •Scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit.
- •for prostate cancer patients: 2 or more increasing prostate specific antigen (PSA) values i the 6 months prior to visit
- •other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site
- •Inclusion Criteria for Provider Subjects:
- •oncology provider at study site scheduled to see patients meeting criteria above
排除标准
- •for Patient Subjects:
- •Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions
- •Bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution
- •Initiated new anti-cancer therapy within last 2 months
- •Evaluated for possible enrollment/randomization in the last 2 months
- •Prior enrollment/randomization on this recruitment trial
研究组 & 干预措施
Arm 1 (No Intervention)
Patient participants in this arm will receive no intervention but will be approached by their providers for participation in treatment clinical trials as per the usual methods.
Provider participants will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
Arm 2 (Digital Intervention)
Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
干预措施: Digital Intervention (Other)
Arm 3 (Digital Intervention + Community Outreach)
Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.
Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
干预措施: Digital Intervention (Other)
Arm 3 (Digital Intervention + Community Outreach)
Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.
Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
干预措施: Community Outreach (Other)
结局指标
主要结局
Percentage of patients that enroll to early phase cancer treatment clinical trials.
时间窗: within 2 months of randomization
次要结局
- Number of successfully completed outreach efforts(after 30 participants are enrolled to each of arms 2 and 3)
- Percent change in number of African Americans that enroll to cancer clinical trials(2 years after study start)
- Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.(2 years from randomization)