- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05071677
Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer
Determinants of Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer
Study Overview
Status
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
- 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
- Invasive Breast Carcinoma
- Triple-Negative Breast Carcinoma
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Makesha V Miggins, MD
- Phone Number: 713-745-2840
- Email: mvmiggins@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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.
|
Participate in interview
Complete survey
Participate in treatment planning meeting
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who accept the recommended treatment plan
Time Frame: 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.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Makesha V Miggins, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1042 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-09081 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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