Clinical trial NCT05760183: Discovering Factors in Metastatic Breast Cancer Patients' Clinical Trial Experiences
Official title: An Observational Medical Trial Assessing Patterns in Experiences of Participants of Metastatic Breast Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-08
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 who are actively considering involvement in an observational metastatic breast cancer clinical trial, but have not yet completed enrollment and registration.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of patients who decide to enroll in a metastatic breast cancer clinical study.
timeFrame: 3 months
measure: Number of metastatic breast 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: 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.
citation: 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.
citation: 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.