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

April 25, 2024 updated by: University of Southern California

Assessing Health Literacy and Interpreter Use in Radiation Oncology at LAC+USC Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County-USC Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

English and Spanish-speaking patients receiving care through LAC + USC radiation oncology who are being seen in consultation for definitive radiation for breast or prostate cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (survey)
Patients complete a survey over 5-10 minutes about their understanding of radiation therapy.
Other: Survey Administration
Complete survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding of radiation therapy information
Time Frame: 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.
Up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation comprehension and satisfaction
Time Frame: 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.
Up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kimberly Miller, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Actual)

April 23, 2024

Study Completion (Actual)

April 23, 2024

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0S-20-6 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2020-06668 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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