Clinical trial NCT05071677: Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer
Official title: Determinants of Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of triple negative invasive breast

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Proportion of patients who accept the recommended treatment plan
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Makesha V Miggins, MD
role: PRINCIPAL_INVESTIGATOR
References: