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

NCT05351424 | Recruiting DMC

• 1 other identifier: AAAT2490
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Invasive; Prostate Cancer

Keywords

breast cancer; prostate cancer; audiovisual intervention; Spanish-speaking; focus group; treatment experience; patient education; radiotherapy adherence; cancer trial participation

Outcome Measures

Primary Outcomes (3)

• 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.

  : 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

  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

  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 Outcomes (2)

• 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

• 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

Study Arms (4)

Audiovisual Intervention- Radiation Therapy Education

EXPERIMENTAL

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

Other: Audiovisual Intervention- Radiation Therapy Education

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

Audiovisual Intervention- Cancer Clinical Trials

EXPERIMENTAL

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

Other: Audiovisual Intervention- Cancer Clinical Trials Education

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

Interventions

ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure OTHER

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

Written Brochure- Radiation Therapy Education

Audiovisual Intervention- Radiation Therapy Education OTHER

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

Audiovisual Intervention- Radiation Therapy Education

Audiovisual Intervention- Cancer Clinical Trials Education OTHER

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

Audiovisual Intervention- 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.

Written Brochure- Cancer Clinical Trials

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females with breast cancer, and males with prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Varian Medical Systems: collaborator

Study Sites (2)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lisa Kachnic, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Chesnakov, MPH

CONTACT

646-317-4244; cc4047@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Radiation Oncology

Model Details: 2x2

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 28, 2022
• Study Start: May 3, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)