Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

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.

III. Evaluate the association of Reliance on Formal or Informal Resources as a moderator of the relationship between intention and final treatment decision.

OUTLINE:

Patients participate in a standard of care treatment planning meeting over 3 hours with members of the multidisciplinary treatment team including, the oncologist, radiologist, oncology surgeon, and social worker. Patients then complete surveys over 20 minutes and within 30 days later. Some patients may participate in interviews over 30 minutes.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

62

Study ID:

NCT05071677

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Makesha V. Miggins
Contact
713-745-2840
[email protected]
Makesha V. Miggins, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

62

Study ID:

NCT05071677

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

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