Looking At Triple Negative Breast Cancer Patient Experience Patterns in Medical Trials

NCT05769491 | Not Yet Recruiting

• 1 other identifier: 84434789
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Triple Negative Breast Cancer; Breast Cancer

Keywords

triple negative breast cancer; breast cancer

Outcome Measures

Primary Outcomes (2)

• Number of triple negative breast cancer patients who decide to enroll in a clinical study

  3 months

• Rate of triple negative breast cancer patients who remain in a clinical study to completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 27131315 BACKGROUND

• 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.

  PMID: 36175133 BACKGROUND

• 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.

  PMID: 34817505 BACKGROUND

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 15, 2023

Record last verified: 2023-03