Health Literacy in Understanding Radiation Therapy Inform... | NCT04927559

ID	Type	Description	Link
NCI-2020-06668	Registry Identifier	CTRP (Clinical Trial Reporting Program)
0S-20-6	Other Identifier	USC / Norris Comprehensive Cancer Center
P30CA014089	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low accrual

Expanded Access Info

Start Date

Dec 18, 2020Actual

Primary Completion Date

Apr 23, 2024Actual

Completion Date

Apr 23, 2024Actual

First Submitted Date

May 25, 2021

First Submission Date that Met QC Criteria

Jun 8, 2021

First Posted Date

Jun 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2024

Last Update Posted Date

Apr 29, 2024Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Conditions Module

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
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (survey)		Patients complete a survey over 5-10 minutes about their understanding of radiation therapy.	Other: Survey Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey Administration	Other	Complete survey	Observational (survey)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases