Clinical trial NCT05769491: Looking At Triple Negative Breast Cancer Patient Experience Patterns in Medical Trials
Official title: Investigation of Patterns in Clinical Trial Experiences by Patients Participating in Triple Negative Breast Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Triple Negative Breast Cancer
Breast Cancer
Keywords: triple negative breast cancer
breast cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 500
Sex: FEMALE
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: Triple negative breast cancer patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in Triple Negative Breast Cancer clinical trials, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with Triple Negative Breast Cancer who may be invited to participate in clinical research in the years to come.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria:

* Pregnant or lactating woman
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Inability to perform regular electronic reporting

Primary outcomes:
measure: Number of triple negative breast cancer patients who decide to enroll in a clinical study
timeFrame: 3 months
measure: Rate of triple negative breast cancer patients who remain in a clinical study to 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: Shao Z, Chaudhri S, Guo M, Zhang L, Rea D. Neoadjuvant Chemotherapy in Triple Negative Breast Cancer: An Observational Study. Oncol Res. 2016;23(6):291-302. doi: 10.3727/096504016X14562725373879.
citation: Wu B, Sun C, Sun X, Li X. The effect of chemotherapy on survival in oldest old patients with nonmetastatic triple negative breast cancer: A populationbased observational study. J Clin Pharm Ther. 2022 Nov;47(11):1826-1836. doi: 10.1111/jcpt.13776. Epub 2022 Sep 29.
citation: Costa REARD, Oliveira FTR, Araujo ALN, Vieira SC. Prognostic factors in triple-negative breast cancer: a retrospective cohort. Rev Assoc Med Bras (1992). 2021 Jul;67(7):950-957. doi: 10.1590/1806-9282.20210249.