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

Official title

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

Overview

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.

Interventions

• Other Audiovisual Intervention- Radiation Therapy Education
  A video with educational information will be shown regarding radiation therapy.
• Other ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure
  Brochure with written information will be given to the subject regarding radiation therapy.
• Other Audiovisual Intervention- Cancer Clinical Trials Education
  A video with educational information will be shown regarding cancer clinical trials.
• Other NCI Taking Part in Cancer Research Studies Brochure
  Brochure with written information will be given to the subject regarding cancer clinical trials.

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 (2)

• 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

Pilot Phase Inclusion Criteria:

• 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

Pilot Phase Exclusion Criteria:

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

Main Study Inclusion Criteria:

• 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

Main Study Exclusion Criteria:

• 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
• RT for sites other than breast or prostate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• Mount Sinai Medical Center — Miami Beach
• Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT05351424 · AAAT2490

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗