Clinical trial NCT05789628: Discovering Factors in Cervical Cancer Patients' Clinical Trial Experiences
Official title: A Look at the Patterns in Medical Research Participation Among Patients With Cervical Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-29
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: Patients who are actively considering involvement in an observational cervical cancer clinical trial, but have not yet completed enrollment and registration.

Brief summary: The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.

This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for cervical cancer.

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 cervical cancer studies.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

Primary outcomes:
measure: Rate of patients who decide to enroll in a cervical cancer clinical study.
timeFrame: 3 months
measure: Number of cervical cancer study participants 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: Hu L, Bell D, Antani S, Xue Z, Yu K, Horning MP, Gachuhi N, Wilson B, Jaiswal MS, Befano B, Long LR, Herrero R, Einstein MH, Burk RD, Demarco M, Gage JC, Rodriguez AC, Wentzensen N, Schiffman M. An Observational Study of Deep Learning and Automated Evaluation of Cervical Images for Cancer Screening. J Natl Cancer Inst. 2019 Sep 1;111(9):923-932. doi: 10.1093/jnci/djy225.
citation: Peirson L, Fitzpatrick-Lewis D, Ciliska D, Warren R. Screening for cervical cancer: a systematic review and meta-analysis. Syst Rev. 2013 May 24;2:35. doi: 10.1186/2046-4053-2-35.
citation: Saei Ghare Naz M, Kariman N, Ebadi A, Ozgoli G, Ghasemi V, Rashidi Fakari F. Educational Interventions for Cervical Cancer Screening Behavior of Women: A Systematic Review. Asian Pac J Cancer Prev. 2018 Apr 25;19(4):875-884. doi: 10.22034/APJCP.2018.19.4.875.