NCT04927559

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

3.3 years

First QC Date

May 25, 2021

Last Update Submit

April 25, 2024

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Stage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage IIA Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Radiation comprehension and satisfaction

    Up to 1 week

Study Arms (1)

Observational (survey)

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

Other: Survey Administration

Interventions

Survey AdministrationOTHER

Complete survey

Observational (survey)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kimberly Miller, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 16, 2021

Study Start

December 18, 2020

Primary Completion

April 23, 2024

Study Completion

April 23, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations

US(1)