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NCT05351424 | RECRUITING | Breast Cancer Invasive

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

Columbia University

Information provided by (Responsible Party):

Lisa A. Kachnic

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.

Condition or disease

Breast Cancer Invasive

Prostate Cancer

Intervention/treatment

Audiovisual Intervention- Radiation Therapy Education

ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

Audiovisual Intervention- Cancer Clinical Trials Education

NCI Taking Part in Cancer Research Studies Brochure

Phase

NA

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
Estimated Enrollment : 194 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Audiovisual Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology
Actual Study Start Date : 2022-05-03
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc

Location Details

NCT05351424

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How to Participate

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Locations

RECRUITING

United States, Florida

Mount Sinai Medical Center

Miami Beach, Florida, United States, 33140

RECRUITING

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032