Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer
NCT ID: NCT05071677
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2021-05-03
2023-08-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Discussion
Participate in treatment planning meeting
Interview
Participate in interview
Survey Administration
Complete survey
Interventions
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Discussion
Participate in treatment planning meeting
Interview
Participate in interview
Survey Administration
Complete survey
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 newly diagnosed bilateral breast cancer
* Patients with psychiatric disorders that exceed moderate severity documented within patient medical record
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Makesha V Miggins, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2021-09081
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-1042
Identifier Type: OTHER
Identifier Source: secondary_id
2019-1042
Identifier Type: -
Identifier Source: org_study_id
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