Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies
ConditionSmall-cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAddario Lung Cancer Medical Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults (USA-based) with a diagnosis of extensive stage primary SCLC or tSCLC
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: SCLC (primary de novo)
Group B: SCLC (transformed)
Trial outcomes
Primary outcomes
1
Feasibility of conducting trial in SCLC population
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.
Time frame
12 monthsOther outcomes
1
Bio-specimen collection
Percentage of blood collections during trial in overall enrolled and in SCLC enrolled compared to in tSCLC enrolled. Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (Overall and in SCLC compared to tSCLC). Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (Overall and in SCLC compared to tSCLC). Reasons for failure to obtain blood collections.
Time frame
12 months2
Subject Surveys (baseline and at 3 months)
Percentage of successful Survey completions; at baseline; at Month 3. Reasons for failure to complete Survey(s).
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov