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

  • STATUS
    Recruiting
  • End date
    Dec 9, 2029
  • participants needed
    62
  • sponsor
    M.D. Anderson Cancer Center
Updated on 21 March 2022

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.

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.

Details
Condition Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
Treatment Interview, survey administration, Discussion
Clinical Study IdentifierNCT05071677
SponsorM.D. Anderson Cancer Center
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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