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

Clinicaltrials.gov ID: NCT05351424
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 194

Conditions

Breast Cancer Invasive, Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Principal Investigator

  • Lisa Kachnic, MD

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

Study Plan

Audiovisual Intervention- Radiation Therapy Education

EXPERIMENTAL

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

  • OTHER:

    Audiovisual Intervention- Radiation Therapy Education

    Description:

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

Written Brochure- Radiation Therapy Education

ACTIVE_COMPARATOR

Written brochures will be provided to the subjects as educational material.

  • OTHER:

    ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

    Description:

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

Audiovisual Intervention- Cancer Clinical Trials

EXPERIMENTAL

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

  • OTHER:

    Audiovisual Intervention- Cancer Clinical Trials Education

    Description:

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

Written Brochure- Cancer Clinical Trials

ACTIVE_COMPARATOR

Written brochures will be provided to the subjects as educational material.

  • OTHER:

    NCI Taking Part in Cancer Research Studies Brochure

    Description:

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

Outcome Measures

Primary Outcome Measures

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)

Radiation Therapy (RT) Adherence Score

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

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)

Secondary Outcome Measures

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

Timeline

  • Last Updated
    June 7, 2024
  • Start Date
    April 28, 2022
  • Today
    May 12, 2025
  • Completion Date ( Estimated )
    December 31, 2026

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