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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071677
Other study ID # 2019-1042
Secondary ID NCI-2021-0908120
Status Completed
Phase
First received
Last updated
Start date May 3, 2021
Est. completion date August 7, 2023

Study information

Verified date August 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 7, 2023
Est. primary completion date August 7, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • 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
  • Breast Neoplasms
  • Carcinoma
  • 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 Neoplasms
  • Triple-Negative Breast Carcinoma

Intervention

Procedure:
Discussion
Participate in treatment planning meeting
Other:
Interview
Participate in interview
Survey Administration
Complete survey

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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