NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation Randomized Controlled Trial (NYC CONNECT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,160
- 试验地点
- 4
- 主要终点
- Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment
研究概览
简要总结
NYC CONNECT will carry out a randomized controlled trial (RCT) which will assess the relative effectiveness of two evidence-based strategies to increase cancer screening rates for breast, cervical, and colorectal cancer. The RCT will compare the effectiveness of using a combination of 1) culturally and linguistically tailored cancer education materials and 2) community health workers (CHWs) to provide navigation services for cancer screening (the "patient navigation" [PN] arm) versus providing culturally and linguistically tailored cancer education only (the "less intensive" [LI] arm). The study population will include individuals who are due for breast, cervical, or colorectal cancer screening. All individuals recruited to the study will be provided navigation for unmet social determinants of health (SDH) needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 21 and 75 years;
- •Men between the ages of 45 and 75 years;
- •Women (40-74 years) who have not had a mammogram in the past 12 months, a Pap smear in the last 3 years (21-64 years old) or HPV test in the last 5 years (30-64 years old), or women 45-75 years old who are not up-to-date on colorectal cancer screening (Fecal occult blood test (FOBT)/Fecal immunochemical test (FIT) past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
- •Men not up-to-date on colorectal cancer screening (FOBT/FIT past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
- •Must speak either English, Spanish, Haitian-Creole, French, or Chinese (Mandarin and Cantonese);
- •Lives in East Flatbush (zip codes: 11236, 11203, 11212, 11226); Sunset Park (zip codes: 11215, 11220, 11232); Highbridge (zip code 10452, 10455, 10451); or Morrisania (zip codes: 10456, 10459)
排除标准
- •Previous or current diagnosis of any cancer;
- •Pregnancy (breast and cervical cancer only);
- •Current participation in an existing cancer navigation program;
- •Currently in hospice care;
- •At least 66 years of age with advanced illness or frailty or who live in long-term institution for more than 90 days;
- •Bilateral mastectomy or right and left unilateral mastectomy (breast cancer only);
- •Hysterectomy with no residual cervix (cervical cancer only);
- •Total colectomy (colorectal cancer only).
结局指标
主要结局
Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment
时间窗: Up to Month 6
Cancer screening defined as a breast, cervical, or colorectal cancer screening.
次要结局
未报告次要终点