Clinical trial NCT06486428: Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies
Official title: A Study to Evaluate a Remote, Decentralized, Direct-to-Patient Strategy for Clinical Research Engagement of Patients With Small Cell Lung Cancer (SCLC), in the Context of a Bio-specimen Collection Study, and to Identify Patient-Reported Preferences and Needs Regarding Choosing and Accessing Novel Therapies and Supportive Gaps.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Small-cell Lung Cancer
Keywords: SCLC
Lung Cancer
Lead sponsor: Addario Lung Cancer Medical Institute
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (USA-based) with a diagnosis of extensive stage primary SCLC or tSCLC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Men or women greater than or equal to 18 years of age at the time of consent
2. Ability to read, write and communicate in English
3. Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
4. Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required
5. Willing to comply with the requirements of the study
6. Diagnosis of extensive stage primary SCLC or tSCLC

Exclusion Criteria:

1. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements
2. Subjects who previously enrolled to this study

Note: Concurrent enrollment in other clinical trials is NOT exclusionary

Primary outcomes:
measure: Feasibility of conducting trial in SCLC population
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Bio-specimen collection
timeFrame: 12 months
measure: Subject Surveys (baseline and at 3 months)
timeFrame: 3 months
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center, Nashville, TN
name: Christine Lovly, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: