AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc (ADELANTE)

February 10, 2026 updated by: Lisa A. Kachnic, Columbia University

Audiovisual Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology

The study aims to develop educational media interventions to prepare Latinx Spanish-speaking radiation oncology patients for a course of breast or prostate cancer radiation therapy and to foster receptivity and informed decision-making around cancer clinical trial participation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research suggests that utilization of audiovisual educational interventions may help to address health literacy and language barriers as well as suboptimal outcomes and trial enrollment in minority and/or non-English speaking patients. However, this has yet to be demonstrated in the radiation oncology setting, in which educational material is limited to written brochures for non-English speaking patients. Herein, the investigators propose to develop and implement a targeted linguistically and culturally appropriate audiovisual intervention (AVI) for Latinx/Spanish-speaking (SS) patients undergoing curative radiotherapy (RT). Our overall objective is to demonstrate benefit of AVI on RT knowledge, adherence, satisfaction and cancer trial perceptivity and enrollment in Latinx/SS patients. The investigators also aim to identify patient-specific and modifiable system-level factors predictive of quality RT delivery and clinical trial accrual to instruct future demographic-segmentation strategies focused on reducing outcomes disparities within radiation oncology.

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Pilot Phase Inclusion Criteria:

  1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
  2. Currently undergoing treatment for breast or prostate cancer, or recently been treated

Pilot Phase Exclusion Criteria:

  1. Patient with bilateral deafness and/or blindness
  2. Patient with psychosis and/or dementia

Main Study Inclusion Criteria:

  1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
  2. Patients with non-metastatic prostate or breast cancer
  3. Histopathologically proven diagnosis of prostate or breast cancer
  4. History and physical examination within 28 days prior to enrollment
  5. Karnofsky performance status 70 or greater
  6. For women of childbearing potential, pregnancy testing to be performed in accordance to institutional guidelines
  7. Plan to receive definitive, curative radiation. Patients planning to receive curative RT after upcoming adjuvant chemotherapy or induction hormonal therapy may enroll at reconsult "follow-up" visit.
  8. Consultation visit must be performed with a certified interpreter

Main Study Exclusion Criteria:

  1. Patient with bilateral deafness and/or blindness
  2. Patient with psychosis and/or dementia
  3. Clinical or radiological evidence of metastatic disease
  4. Prior participation in cancer patient education trial
  5. Prior RT
  6. RT for sites other than breast or prostate

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Audiovisual Intervention- Radiation Therapy Education
Audiovisual video will be provided to the subjects as educational material.
Other: Audiovisual Intervention- Radiation Therapy Education
A video with educational information will be shown regarding radiation therapy.
Active Comparator: Written Brochure- Radiation Therapy Education
Written brochures will be provided to the subjects as educational material.
Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure
Brochure with written information will be given to the subject regarding radiation therapy.
Experimental: Audiovisual Intervention- Cancer Clinical Trials
Audiovisual video will be provided to the subjects as educational material.
Other: Audiovisual Intervention- Cancer Clinical Trials Education
A video with educational information will be shown regarding cancer clinical trials.
Active Comparator: Written Brochure- Cancer Clinical Trials
Written brochures will be provided to the subjects as educational material.
Other: NCI Taking Part in Cancer Research Studies Brochure
Brochure with written information will be given to the subject regarding cancer clinical trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Therapy (RT) Knowledge Questionnaire
Time Frame: : baseline prior to first randomization (within 1 week of enrollment for both breast and prostate cancer) and before CT simulation visit, and again during CT simulation visit (1-4 weeks from enrollment for both breast and prostate cancer)
Subjects will complete the "RT Knowledge Questionnaire" to measure the change in the subjects' understanding of radiation therapy. This will be administered twice- once prior the subject receiving either the AVI or written brochure on RT knowledge and before CT simulation, and again on the same day after CT simulation.
: baseline prior to first randomization (within 1 week of enrollment for both breast and prostate cancer) and before CT simulation visit, and again during CT simulation visit (1-4 weeks from enrollment for both breast and prostate cancer)
Radiation Therapy (RT) Adherence Score
Time Frame: up to 6 weeks after completion of Radiation Therapy
Reflects the frequency of unplanned treatment and clinic absence as well as subject compliance of provider recommendations
up to 6 weeks after completion of Radiation Therapy
Radiation Therapy (RT) Satisfaction Questionnaire
Time Frame: during or immediately prior to the end-of-treatment visit (4-6 weeks from enrollment for breast cancer, 4-9 weeks from enrollment for prostate cancer)
Adapted for radiation oncology setting from the CAHPS Cancer Center and EORTC Cancer Patient Satisfaction Surveys
during or immediately prior to the end-of-treatment visit (4-6 weeks from enrollment for breast cancer, 4-9 weeks from enrollment for prostate cancer)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Trials Perceptivity Questionnaire
Time Frame: Prior to second randomization during the last week of radiation therapy (4-6 weeks after enrollment for breast cancer, 4-9 weeks for prostate cancer) and again during the first follow-up visit after completing radiation therapy (8-12 weeks from e
Subjects will complete the "Clinical Trials Perceptivity Questionnaire" to measure the change in the subjects' understanding of cancer clinical trials. This will be administered twice- once during the last week of RT prior to the subject receiving either the AVI or written brochure on cancer clinical trials, and again during the first follow-up visit after completing radiation therapy.
Prior to second randomization during the last week of radiation therapy (4-6 weeks after enrollment for breast cancer, 4-9 weeks for prostate cancer) and again during the first follow-up visit after completing radiation therapy (8-12 weeks from e
Clinical trial enrollment
Time Frame: following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years
Subjects' medical records will be reviewed to ascertain the number subsequent cancer clinical trials they enroll in after completing radiation therapy, for up to 5 years
following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years

Collaborators and Investigators

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

Sponsor

Columbia University

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Lisa Kachnic, MD, Columbia University

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)

May 3, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 24, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT2490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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