Health Literacy in Understanding Radiation Therapy Information in Patients Undergoing Definitive Radiation Therapy

Terminated

• Conditions: Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Stage I Prostate Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8
• Interventions: Other: Survey Administration

• Registration Number: NCT04927559
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess patient health literacy and understanding of critical radiation information during consultation in Spanish and English speaking patient in the department of radiation oncology at Los Angeles County (LAC) + University of Southern California (USC) utilizing a patient survey administered after consultation.

SECONDARY OBJECTIVE:

I. Correlate findings of radiation comprehension and satisfaction with validated measures of health literacy, acculturation, and socioeconomic status of patients.

TERTIARY OBJECTIVE:

I. To assess patient satisfaction of interpreter service in Spanish-speaking patients among breast and prostate cancer patients receiving definitive radiation.

OUTLINE:

Patients complete a survey over 5-10 minutes about their understanding of radiation therapy.

Study Timeline

• Study Start: 2020-12-18
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-16
• Status Verified: 2024-04
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (survey)	Survey Administration	Patients complete a survey over 5-10 minutes about their understanding of radiation therapy.

Primary Outcome Measures

Name	Time	Method
Understanding of radiation therapy information	Up to 1 week	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.

Secondary Outcome Measures

Name	Time	Method
Radiation comprehension and satisfaction	Up to 1 week	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.

Trial Locations

Locations (1)

Los Angeles County-USC Medical Center; 🇺🇸 Los Angeles, California, United States