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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Completed

Conditions

Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Triple-Negative Breast Carcinoma
Prognostic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Invasive Breast Carcinoma
Anatomic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8

Treatments

Other: Interview
Procedure: Discussion
Other: Survey Administration

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT05071677
NCI-2021-09081 (Registry Identifier)
2019-1042 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Observational (survey, interview)
Description:
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.
Treatment:
Procedure: Discussion
Other: Survey Administration
Other: Interview

Trial contacts and locations

1

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Central trial contact

Makesha V Miggins, MD

Data sourced from clinicaltrials.gov

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