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

Not Applicable

Recruiting

• Conditions: Breast Cancer Invasive; Prostate Cancer
• Interventions: Other: NCI Taking Part in Cancer Research Studies Brochure; Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure; Other: Audiovisual Intervention- Radiation Therapy Education; Other: Audiovisual Intervention- Cancer Clinical Trials Education

• Registration Number: NCT05351424
• Lead Sponsor: Columbia University

Brief 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.

Study Timeline

• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-24
• Study First Posted: 2022-04-28
• Study Start: 2022-05-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Written Brochure- Cancer Clinical Trials	NCI Taking Part in Cancer Research Studies Brochure	Written brochures will be provided to the subjects as educational material.
Written Brochure- Radiation Therapy Education	ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure	Written brochures will be provided to the subjects as educational material.
Audiovisual Intervention- Radiation Therapy Education	Audiovisual Intervention- Radiation Therapy Education	Audiovisual video will be provided to the subjects as educational material.
Audiovisual Intervention- Cancer Clinical Trials	Audiovisual Intervention- Cancer Clinical Trials Education	Audiovisual video will be provided to the subjects as educational material.

Primary Outcome Measures

Name	Time	Method
Radiation Therapy (RT) Knowledge Questionnaire	: 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.
Radiation Therapy (RT) Adherence Score	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
Radiation Therapy (RT) Satisfaction Questionnaire	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 Outcome Measures

Name	Time	Method
Clinical trial enrollment	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
Clinical Trials Perceptivity Questionnaire	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.

Trial Locations

Locations (2)

Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States