A Study to Evaluate a Remote, Decentralized, Direct-to-Patient Strategy for Clinical Research Engagement of Patients With Small Cell Lung Cancer (SCLC).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Feasibility of conducting trial in SCLC population
研究概览
简要总结
This study will evaluate if a direct-to-patient, de-centralized, remote approach will improve clinical research outreach and engagement for patients with SCLC, in the context of a bio-specimen collection study. The study will also assess self-reported preferences and needs of patients with SCLC, regarding choosing and accessing novel therapies in research or standard clinical care settings and supportive gaps in this area, through an initial and 3 month follow up survey.
详细描述
This is a non-interventional, non-treatment, non-randomized, single coordinating center, study to determine the feasibility of decentralized bio-specimen collection in USA-based adult subjects with SCLC, to be conducted in conformance with Good Clinical Practices. Potential study subjects will be referred to contact staff through a dedicated study webpage form or dedicated study phone hotline at the coordinating center (ALCMI) who will handle informed consent, coordinate remote blood sample collection with study subjects, and collect medical records to confirm diagnosis and treatment history. Subjects will also be asked to complete a baseline and follow up questionnaire/survey documenting their self-report diagnosis, treatment history, factors impacting care and quality of life, and needs/preferences regarding supportive resources.
Patients who have been diagnosed with either extensive stage primary SCLC or patients diagnosed with primary NSCLC who experienced histological "transformation" with a SCLC component after initial diagnosis and subsequent treatment (transformed SCLC; tSCLC) will be invited to volunteer for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men or women greater than or equal to 18 years of age at the time of consent
- •Ability to read, write and communicate in English
- •Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
- •Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required
- •Willing to comply with the requirements of the study
- •Diagnosis of extensive stage primary SCLC or tSCLC
排除标准
- •Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements
- •Subjects who previously enrolled to this study
- •Note: Concurrent enrollment in other clinical trials is NOT exclusionary
结局指标
主要结局
Feasibility of conducting trial in SCLC population
时间窗: 12 months
Percentage of overall eligible subjects enrolled. Percentage of primary SCLC eligible subjects enrolled. Percentage of tSCLC eligible subjects enrolled. Percentage of SCLC eligible subjects enrolled compared to percentage of tSCLC eligible subjects enrolled. Percentage of primary SCLC enrolled subjects completed. Percentage of tSCLC enrolled subjects completed. Percentage of SCLC enrolled subjects completed compared to percentage of tSCLC enrolled subjects completed. Overall reasons for early termination. Reasons for early termination from trial in primary SCLC enrolled. Reasons for early termination from trial in tSCLC enrolled.
次要结局
未报告次要终点