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RecruitingInterventional

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

NCT ID: NCT05351424Sponsor: Columbia UniversityLast updated: 2026-02-12

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.

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.

Arms & 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.

Outcome measures

Primary

  • 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)

  • 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

  • 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

  • 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

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

Mount Sinai Medical Center

Miami Beach, Florida, 33140

Recruiting
Irina Bakura-Caso · Contact
(305) 674-2625Irina.BakuraCaso@msmc.com

Columbia University Irving Medical Center

New York, New York, 10032

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