Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
Assessing Health Literacy and Interpreter Use in Radiation Oncology at LAC+USC Medical Center
| Verified date | April 2024 |
| Source | University of Southern California |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study assesses the health literacy and understanding of radiation therapy information during consultation in patients with prostate or breast cancer undergoing definitive radiation therapy. Health literacy is defined as "the capacity to obtain, process, and understand health information and services to enable sound health decisions." Information gained from this study, may help researchers develop appropriate modalities to enhance comprehension of radiation therapy, and therefore allow for improved patient decision making with medical treatment.
| Status | Terminated |
| Enrollment | 35 |
| Est. completion date | April 23, 2024 |
| Est. primary completion date | April 23, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - All participants in this study will have cT1-4N0-1M0 prostate cancer or cT1-4N1-3M0 breast cancer, as clinically staged by the attending radiation oncologist following the American Joint Committee on Cancer (AJCC) 8th edition - Non-metastatic breast or prostate cancer - Radiation consultation for definitive treatment - English or Spanish-speaking Exclusion Criteria: - Any person with major cognitive deficit or psychiatric impairment - Any person, who with assistance by a family member or caregiver, is unable to complete a written survey |
| Country | Name | City | State |
|---|---|---|---|
| United States | Los Angeles County-USC Medical Center | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of Southern California | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Understanding of radiation therapy information | Patients will be given an internally developed questionnaire of 11 questions intended to ascertain understanding of basic radiotherapy information that is needed to make an informed decision. The questions with one answer will be given a +1 for correct and -1 for incorrect. The questions with multiple answers (toxicity) will be given a +1 for a correctly chosen side effect, and a -1 for an incorrect response. The total will be the patient's summary score. | Up to 1 week | |
| Secondary | Radiation comprehension and satisfaction | Findings will be correlated with validated measures of health literacy, acculturation, and socioeconomic status of patients. Will assess variables associated with post-consult knowledge, with independent variables (IVs) comprising of ethnicity, cultural factors (nativity, acculturation), level of health literacy, sex, and socioeconomic status in linear regression models. Bivariate analyses will initially be conducted between IVs and the outcome; variables that are significant at p < 0.10 will be included in the multivariable model. Interaction terms will also be examined to test for differences by Hispanic/non-Hispanic ethnicity (the outcome regressed on Hispanic*IVs). The alpha level for the multivariable model will be p < 0.05. | Up to 1 week |
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