Clinical trial NCT05769504: Examining Clinical Trial Participation for Small Cell Lung Cancer Patients
Official title: Studying Patient Experiences in Small Cell Lung Cancer Clinical Trials to Identify Influencing Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Small Cell Lung Cancer
Keywords: small cell lung cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Small cell lung cancer patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Brief summary: Clinical study participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future small cell lung cancer patients during clinical trials.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Participant has a diagnosis of small cell lung cancer.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Pregnant or lactating woman
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Primary outcomes:
measure: Rate of patients who decide to enroll in a small cell lung cancer clinical study.
timeFrame: 3 months
measure: Number of small cell lung cancer patients who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: van Meerbeeck JP, Fennell DA, De Ruysscher DK. Small-cell lung cancer. Lancet. 2011 Nov 12;378(9804):1741-55. doi: 10.1016/S0140-6736(11)60165-7. Epub 2011 May 10.
citation: Seto Z, Takata N, Murayama N, Tokui K, Okazawa S, Kambara K, Imanishi S, Miwa T, Hayashi R, Matsui S, Inomata M. Irinotecan monotherapy as third- or further-line treatment for patients with small cell lung cancer. Tumori. 2021 Dec;107(6):536-541. doi: 10.1177/0300891620974762. Epub 2020 Nov 25.
citation: Xing H, Zhang J, Ge F, Yu X, Bian H, Zhang F, Fang J. [Analysis of the Efficacy of Irinotecan in the Second-line Treatment of Refractory and Relapsed Small Cell Lung Cancer]. Zhongguo Fei Ai Za Zhi. 2021 Mar 20;24(3):167-172. doi: 10.3779/j.issn.1009-3419.2021.103.04. Chinese.