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

NCT05071677 | Completed

• 2 other identifiers: 2019-1042NCI-2021-09081
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who accept the recommended treatment plan

  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.

  through study completion, an average of 1 year

Study Arms (1)

Observational (survey, interview)

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.

Procedure: Discussion; Other: Interview; Other: Survey Administration

Interventions

Discussion PROCEDURE

Participate in treatment planning meeting

Also known as: Discuss

Observational (survey, interview)

Interview OTHER

Participate in interview

Observational (survey, interview)

Survey Administration OTHER

Complete survey

Observational (survey, interview)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of triple negative invasive breast

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Makesha V Miggins, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 8, 2021
• Study Start: May 3, 2021
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

US (1)