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

Completed

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Invasive Breast Carcinoma; Prognostic Stage IIIB Breast Cancer AJCC v8
• Interventions: Procedure: Discussion; Other: Interview; Other: Survey Administration

• Registration Number: NCT05071677
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-08
• Status Verified: 2023-08
• Primary Completion: 2023-08-07
• Study Completion: 2023-08-07
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (survey, interview)	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.
Observational (survey, interview)	Survey Administration	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.
Observational (survey, interview)	Discussion	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who accept the recommended treatment plan	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States