Clinical trial NCT05967481: Evaluation of Study Experiences of Neuroendocrine Tumor Patients
Official title: Investigating the Clinical Trial Journey and Engagement of Neuroendocrine Tumor Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neuroendocrine Tumors
Keywords: neuroendocrine tumor
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-01
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: Patients with neuroendocrine tumor who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.

Brief summary: Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This research will admit a wide range of data on the clinical study experience of neuroendocrine tumor patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with neuroendocrine tumor.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of neuroendocrine tumor
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Enrolled in another research study
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or lactating woman

Primary outcomes:
measure: Rate of patients who decide to join in a neuroendocrine tumor clinical research
timeFrame: 3 months
measure: Number of neuroendocrine tumor patients who remain in clinical trial until completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Walter T, Krzyzanowska MK. Quality of clinical trials in gastroenteropancreatic neuroendocrine tumours. Neuroendocrinology. 2012;96(3):238-48. doi: 10.1159/000337662. Epub 2012 Aug 28.
citation: Faggiano A, Malandrino P, Modica R, Agrimi D, Aversano M, Bassi V, Giordano EA, Guarnotta V, Logoluso FA, Messina E, Nicastro V, Nuzzo V, Sciaraffia M, Colao A. Efficacy and Safety of Everolimus in Extrapancreatic Neuroendocrine Tumor: A Comprehensive Review of Literature. Oncologist. 2016 Jul;21(7):875-86. doi: 10.1634/theoncologist.2015-0420. Epub 2016 Apr 6.
citation: Capdevila J, Teule A, Barriuso J, Castellano D, Lopez C, Manzano JL, Alonso V, Garcia-Carbonero R, Dotor E, Matos I, Custodio A, Casanovas O, Salazar R; EVERLAR study investigators. Phase II Study of Everolimus and Octreotide LAR in Patients with Nonfunctioning Gastrointestinal Neuroendocrine Tumors: The GETNE1003_EVERLAR Study. Oncologist. 2019 Jan;24(1):38-46. doi: 10.1634/theoncologist.2017-0622. Epub 2018 May 23.