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

Primary Purpose

Breast Cancer Invasive, Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Audiovisual Intervention- Radiation Therapy Education

ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

Audiovisual Intervention- Cancer Clinical Trials Education

NCI Taking Part in Cancer Research Studies Brochure

About this trial

This is an interventional health services research trial for Breast Cancer Invasive focused on measuring breast cancer, prostate cancer, audiovisual intervention, Spanish-speaking, focus group, treatment experience, patient education, radiotherapy adherence, cancer trial participation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Audiovisual Intervention- Radiation Therapy Education

Written Brochure- Radiation Therapy Education

Audiovisual Intervention- Cancer Clinical Trials

Written Brochure- Cancer Clinical Trials

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Radiation Therapy (RT) Adherence Score

Reflects the frequency of unplanned treatment and clinic absence as well as subject compliance of provider recommendations

Radiation Therapy (RT) Satisfaction Questionnaire

Adapted for radiation oncology setting from the CAHPS Cancer Center and EORTC Cancer Patient Satisfaction Surveys

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT05351424

First Posted

March 31, 2022

Last Updated

July 12, 2023

Sponsor

Columbia University

Collaborators

Varian Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT05351424

Brief Title

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

Acronym

ADELANTE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 3, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Varian Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

2x2

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Audiovisual Intervention- Radiation Therapy Education

Arm Type

Experimental

Arm Description

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

Arm Title

Written Brochure- Radiation Therapy Education

Arm Type

Active Comparator

Arm Description

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

Arm Title

Audiovisual Intervention- Cancer Clinical Trials

Arm Type

Experimental

Arm Description

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

Arm Title

Written Brochure- Cancer Clinical Trials

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Audiovisual Intervention- Radiation Therapy Education

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Audiovisual Intervention- Cancer Clinical Trials Education

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

NCI Taking Part in Cancer Research Studies Brochure

Intervention Description

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

Primary Outcome Measure Information:

Title

Radiation Therapy (RT) Knowledge Questionnaire

Description

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)

Title

Radiation Therapy (RT) Adherence Score

Description

Reflects the frequency of unplanned treatment and clinic absence as well as subject compliance of provider recommendations

Time Frame

up to 6 weeks after completion of Radiation Therapy

Title

Radiation Therapy (RT) Satisfaction Questionnaire

Description

Adapted for radiation oncology setting from the CAHPS Cancer Center and EORTC Cancer Patient Satisfaction Surveys

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 Measure Information:

Title

Clinical Trials Perceptivity Questionnaire

Description

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

Title

Clinical trial enrollment

Description

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

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

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

females with breast cancer, males with prostate cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oscar Padilla, MD

Phone

212-305-7077

op2237@cumc.columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mariamne Reyna

Phone

646-317-4244

mo2213@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Kachnic, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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