Clincosm LogoSign in Get a demo

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

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT04927559
Collaborator
National Cancer Institute (NCI) (NIH)
100
Enrollment
2
Locations
42
Anticipated Duration (Months)
50
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. Correlate findings of radiation comprehension and satisfaction with validated measures of health literacy, acculturation, and socioeconomic status of patients.
TERTIARY OBJECTIVE:
  1. 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Assessing Health Literacy and Interpreter Use in Radiation Oncology at LAC+USC Medical Center
Actual Study Start Date :
Dec 18, 2020
Anticipated Primary Completion Date :
Dec 18, 2023
Anticipated Study Completion Date :
Jun 18, 2024

Arms and Interventions

Arm Intervention/Treatment
Observational (survey)

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

Other: Survey Administration
Complete survey

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Los Angeles County-USC Medical Center Los Angeles California United States 90033
2 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Omar M Ragab, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern California
ClinicalTrials.gov Identifier:
NCT04927559
Other Study ID Numbers:
  • 0S-20-6
  • NCI-2020-06668
  • 0S-20-6
  • P30CA014089
First Posted:
Jun 16, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
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
Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 9, 2022