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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05071677
Collaborator
National Cancer Institute (NCI) (NIH)
62
Enrollment
1
Location
103.2
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Discussion
  • Other: Interview
  • Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. Evaluate the acceptance of treatment recommendations by African American women diagnosed with triple negative breast cancer (TNBC).
SECONDARY OBJECTIVES:

  1. Evaluate the association of beliefs about chemotherapy, self-efficacy, and cancer-specific psychological distress with intention to follow through with treatment.

  2. Evaluate the association of intention, Reliance on Formal or Informal Resources, and decisional conflict as predictors of final treatment decision.

  3. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
62 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Determinants of Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer
Actual Study Start Date :
May 3, 2021
Anticipated Primary Completion Date :
Dec 9, 2029
Anticipated Study Completion Date :
Dec 9, 2029

Arms and Interventions

Arm Intervention/Treatment
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
Participate in treatment planning meeting
Other Names:
  • Discuss

    • Other: Interview
    Participate in interview

    Other: Survey Administration
    Complete survey

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Makesha V Miggins, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05071677
    Other Study ID Numbers:
    • 2019-1042
    • NCI-2021-09081
    • 2019-1042
    First Posted:
    Oct 8, 2021
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms
    Triple Negative Breast Neoplasms

    Study Results

    No Results Posted as of Jan 14, 2022