CClinicalTrials.gg
RecruitingNCT05351424ADELANTEUpdated Feb 12, 2026

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

An interventional study of Audiovisual Intervention- Radiation Therapy Education and ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure in Breast Cancer Invasive and Prostate Cancer, sponsored by Columbia University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Columbia University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Breast Cancer Invasive
  • Prostate Cancer

Keywords

  • breast cancer
  • prostate cancer
  • audiovisual intervention
  • Spanish-speaking
  • focus group
  • treatment experience
  • patient education
  • radiotherapy adherence
  • cancer trial participation
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 194 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
194 participants (estimated)

Study arms

  • Experimental
    Audiovisual Intervention- Radiation Therapy Education

    Audiovisual video will be provided to the subjects as educational material.

    Other: Audiovisual Intervention- Radiation Therapy Education

  • 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

  • Experimental
    Audiovisual Intervention- Cancer Clinical Trials

    Audiovisual video will be provided to the subjects as educational material.

    Other: Audiovisual Intervention- Cancer Clinical Trials Education

  • 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

Interventions

  • OtherAudiovisual Intervention- Radiation Therapy Education

    A video with educational information will be shown regarding radiation therapy.

  • OtherASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

    Brochure with written information will be given to the subject regarding radiation therapy.

  • OtherAudiovisual Intervention- Cancer Clinical Trials Education

    A video with educational information will be shown regarding cancer clinical trials.

  • OtherNCI Taking Part in Cancer Research Studies Brochure

    Brochure with written information will be given to the subject regarding cancer clinical trials.

06

What researchers measure

Primary outcomes

  1. Radiation Therapy (RT) Knowledge Questionnaire

    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.

    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)

  2. Radiation Therapy (RT) Adherence Score

    Reflects the frequency of unplanned treatment and clinic absence as well as subject compliance of provider recommendations

    Time frame: up to 6 weeks after completion of Radiation Therapy

  3. Radiation Therapy (RT) Satisfaction Questionnaire

    Adapted for radiation oncology setting from the CAHPS Cancer Center and EORTC Cancer Patient Satisfaction Surveys

    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)

Secondary outcomes

  1. Clinical Trials Perceptivity Questionnaire

    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.

    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

  2. Clinical trial enrollment

    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

    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

07

Study locations

2 of 2 sites recruiting
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
    Recruiting
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05351424
Lead sponsor
Columbia University
Collaborators
Varian Medical Systems
Responsible party
Lisa A. Kachnic (Professor and Chair, Department of Radiation Oncology, Columbia University) — Principal investigator
First posted
Apr 28, 2022
Start date
May 3, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 12, 2026

Study contacts

Christina Chesnakov, MPH
Contact
cc4047@cumc.columbia.edu
646-317-4244
Lisa Kachnic, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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