Discovering Factors in Metastatic Breast Cancer Patients' Clinical Trial Experiences

NCT05760183 | Not Yet Recruiting

• 1 other identifier: 82944089
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This trial will evaluate the safety and efficacy of metastatic breast cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. 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 metastatic breast cancer studies.

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancer

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a metastatic breast cancer clinical study.

  3 months

• Number of metastatic breast cancer study participants who remain in clinical trial until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are actively considering involvement in an observational metastatic breast cancer clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• Patient is at least 18 years of age
• Patient is able and willing to comply with the treatment/follow-up schedule and requirements
• Patient must provide written informed consent

You may not qualify if:

• Women who are pregnant, intend to become pregnant, or are lactating
• Inability to perform regular electronic reporting
• Participants who are vulnerable to any intervention

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Conde-Estevez D, Tusquets I, Servitja S, Martinez-Garcia M, Salas E, Albanell J. An overview of randomized clinical trials in metastatic breast cancer: variables affecting regulatory drug approval. Anticancer Drugs. 2014 Oct;25(9):992-7. doi: 10.1097/CAD.0000000000000130.

  PMID: 24892723 BACKGROUND

• Kuerer HM, van la Parra RF. Breast Cancer Clinical Trials: Past Half Century Moving Forward Advancing Patient Outcomes. Ann Surg Oncol. 2016 Oct;23(10):3145-52. doi: 10.1245/s10434-016-5326-9. Epub 2016 Jun 30.

  PMID: 27364503 BACKGROUND

• Ghislain I, Zikos E, Coens C, Quinten C, Balta V, Tryfonidis K, Piccart M, Zardavas D, Nagele E, Bjelic-Radisic V, Cardoso F, Sprangers MAG, Velikova G, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group; Breast Cancer Group; EORTC Headquarters. Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials. Lancet Oncol. 2016 Jul;17(7):e294-e304. doi: 10.1016/S1470-2045(16)30099-7.

  PMID: 27396647 BACKGROUND

MeSH Terms

Conditions

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

415-900-4227; 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: February 25, 2023
• First Posted: March 8, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 5, 2023

Record last verified: 2023-02