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NCT Number: NCT05351424

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

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.

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Key information

Conditions

Breast Cancer Invasive Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Medical Center, Miami Beach, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pilot Phase Inclusion Criteria:

  • 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
  • Currently undergoing treatment for breast or prostate cancer, or recently been treated

Pilot Phase Exclusion Criteria:

  • Patient with bilateral deafness and/or blindness
  • Patient with psychosis and/or dementia

Main Study Inclusion Criteria:

  • 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
  • Patients with non-metastatic prostate or breast cancer
  • Histopathologically proven diagnosis of prostate or breast cancer
  • History and physical examination within 28 days prior to enrollment
  • Karnofsky performance status 70 or greater
  • For women of childbearing potential, pregnancy testing to be performed in accordance to institutional guidelines
  • 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.
  • Consultation visit must be performed with a certified interpreter

Main Study Exclusion Criteria:

  • Patient with bilateral deafness and/or blindness
  • Patient with psychosis and/or dementia
  • Clinical or radiological evidence of metastatic disease
  • Prior participation in cancer patient education trial
  • Prior RT
  • RT for sites other than breast or prostate

Treatment and study plan

Audiovisual Intervention- Radiation Therapy Education

Other

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

ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

Other

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

Audiovisual Intervention- Cancer Clinical Trials Education

Other

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

NCI Taking Part in Cancer Research Studies Brochure

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Chesnakov, MPH

CONTACT

[email protected]

646-317-4244

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

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

Acronym: ADELANTE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 28, 2022
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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