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临床试验/NCT05071677
NCT05071677已完成不适用

Determinants of Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Proportion of patients who accept the recommended treatment plan

研究概览

简要总结

This study evaluates what influences treatment decision-making in African American women with triple negative breast cancer. The study also aims to learn about the influence of information sources that support this decision-making process.

详细描述

PRIMARY OBJECTIVE:

I. Evaluate the acceptance of treatment recommendations by African American women diagnosed with triple negative breast cancer (TNBC).

SECONDARY OBJECTIVES:

I. Evaluate the association of beliefs about chemotherapy, self-efficacy, and cancer-specific psychological distress with intention to follow through with treatment.

II. Evaluate the association of intention, Reliance on Formal or Informal Resources, and decisional conflict as predictors of final treatment decision.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • New patient in the MD Anderson Cancer Center Nellie B. Connally Breast Center or Houston Area Locations (HALs) (presenting to the surgery clinic, medical oncology clinic, or multiteam clinic)
  • Women 18 years and older treated at MD Anderson Cancer Center between 1/1/2019 and 12/31/2021
  • Diagnosis of triple negative invasive breast cancer on percutaneous needle biopsy within 60 days of first clinic appointment demonstrated by estrogen receptor (ER) 0% (absence or very low presence of estrogen uptake), progesterone receptor (PR) 0% (absence or very low presence of progesterone uptake), and HER2 negative (immunohistochemistry [IHC] score of 0 or 1 or fluorescence in situ hybridization [FISH] non-amplified score 2.0 or less)
  • Tumor size >= 1 cm (chemotherapy is not recommended for tumors < 1 cm)
  • Breast cancer stage I, II, or III
  • Self-identify as of African descent (African American, African, Black, Afro-Caribbean, etc.)
  • Completion of treatment planning team meeting and receipt of treatment at MD Anderson or local oncologist under the guidance of MD Anderson medical oncologist; no time window for treatment completion
  • Ability to read, write, and speak in English, and provide consent

排除标准

  • Patients with previous history of breast cancer diagnosis
  • Patients with newly diagnosed bilateral breast cancer
  • Patients with psychiatric disorders that exceed moderate severity documented within patient medical record

结局指标

主要结局

Proportion of patients who accept the recommended treatment plan

时间窗: through study completion, an average of 1 year

Patient demographics and clinical characteristics will be summarized using numerical summaries for continuous variables and proportions for categorical variables. The proportion of patients who accept the recommended treatment plan will be estimated along with a 95% confidence interval.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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