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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer Invasive, Prostate Cancer

Intervention / Treatment
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* Other: Audiovisual Intervention- Radiation Therapy Education
* Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure
* Other: Audiovisual Intervention- Cancer Clinical Trials Education
* Other: NCI Taking Part in Cancer Research Studies Brochure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audiovisual Intervention- Radiation Therapy Education<br>Audiovisual video will be provided to the subjects as educational material. | Other: Audiovisual Intervention- Radiation Therapy Education<br>* A video with educational information will be shown regarding radiation therapy.<br>|
| Active Comparator: Written Brochure- Radiation Therapy Education<br>Written brochures will be provided to the subjects as educational material. | Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure<br>* Brochure with written information will be given to the subject regarding radiation therapy.<br>|
| Experimental: Audiovisual Intervention- Cancer Clinical Trials<br>Audiovisual video will be provided to the subjects as educational material. | Other: Audiovisual Intervention- Cancer Clinical Trials Education<br>* A video with educational information will be shown regarding cancer clinical trials.<br>|
| Active Comparator: Written Brochure- Cancer Clinical Trials<br>Written brochures will be provided to the subjects as educational material. | Other: NCI Taking Part in Cancer Research Studies Brochure<br>* Brochure with written information will be given to the subject regarding cancer clinical trials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Trials Perceptivity Questionnaire | 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. | 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 | 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 | following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, prostate cancer, audiovisual intervention, Spanish-speaking, focus group, treatment experience, patient education, radiotherapy adherence, cancer trial participation