Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cervical cancer screening
研究概览
简要总结
Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.
详细描述
We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer. We will use the six steps of the Intervention Mapping approach to guide the process of testing the intervention. This project aligns with the current efforts at the University of Florida Health Cancer Institute (UFHCI) and UF Health Internal Medicine to improve cervical cancer screening rates among under-screened women. We will partner with these efforts to test the PINPOINT intervention. Project CONTINUITY (Connecting You to Care in the Community) at UFHCI, Office of Community Outreach and Engagement (COE), is working to increase adherence to cervical screening and follow-up by; (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method, community clinical navigators (CCN) and community health workers (CHWs), customized messages and support for patient portal access for test results, and (2) implementing strategies to address non-medical drivers that may influence an individual's ability to adhere to the screening, with an initial focus on removing transportation barriers through the use of a mobile outreach clinic (MOC).
Currently, a patient navigator supervised by Dr. Dianne Goede identifies patients who have an upcoming office visit and are due for cervical cancer screening at UF Health Internal Medicine. The patient navigator outreaches the patient, reminds them of their overdue status for cervical cancer screening and the importance of cervical cancer screening, and inquires if they are agreeable to complete screening at the scheduled office visit. We will reach out to patients who remain unscreened for cervical cancer 2 months after their scheduled visit with UF Health Internal Medicine. We will obtain a list of patients from the UF Health Consent2Share database. Patients who agree to participate in our study will be randomized to either receive the PINPOINT intervention (self-collection test with patient navigation) or standard of care (reminder to screen from UF Health Internal Medicine). We will use the sealed envelope randomization method to assign participants to either treatment or control groups right after intake.
We will pilot the PINPOINT intervention at UF Internal Medicine clinics and use Proctor's Framework for Implementation Outcomes to evaluate the intervention. Changes will be made to the intervention protocol and tested in a future randomized trial with a larger sample. Hypothesis: PINPOINT will meet the needs of women living with socioeconomic challenges, T2D, and obesity, and will align with the clinical workflow. PINPOINT will be appropriate, feasible and acceptable.27 Outcome: The PINPOINT intervention will have positive outcomes in terms of feasibility and acceptability among patients.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The following eligibility criteria will be used to determine inclusion into the study:
- •Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible
- •Active UF Internal Medicine patient and has had an appointment in the last 2 months.
- •Assigned sex at birth is female
- •Have Obesity or Type 2 Diabetes
- •Not currently pregnant (self-report)
- •Have not given birth in the prior 12 weeks
- •No previous history of cervical cancer
- •No previous history of a hysterectomy
- •Have not undergone cancer screening in the past 3 years or more
- •Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).
- •Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.
- •Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).
排除标准
- •Previous history of cervical cancer
- •Total hysterectomy
研究组 & 干预措施
Intervention
PINPOINT intervention arm will entail assigning patients to a patient navigator to assist them with screening reminders and address any barriers they have to screening, education on cervical cancer screening, and patients will also be offered the opportunity to self-collect their sample for cervical cancer screening.
干预措施: patient navigation and self-collection (Behavioral)
Control Arm
No intervention arm, patients will receive reminders for screening according to current clinical practice
结局指标
主要结局
Cervical cancer screening
时间窗: within 6 months
receiving cervical cancer screening either via self-collection, pap smear, or hpv testing
次要结局
- Acceptability(from enrollment until they complete screening or at the end of the trial at 6 months)
- Appropriateness(from enrollment until they complete screening or at the end of the trial at 6 months)
- Feasibility measure(from enrollment until they complete screening or at the end of the trial at 6 months)