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

Prostate Cancer Clinical Trial

— ADELANTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351424
• Other study ID #: AAAT2490
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Columbia University
• Contact: Oscar Padilla, MD
• Phone: 212-305-7077
• Email: op2237[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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
Secondary	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