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

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05351424

Collaborator

Varian (Other)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Invasive Prostate Cancer	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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

2x22x2

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 3, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Radiation Therapy (RT) Knowledge Questionnaire [: 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)]
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 [up to 6 weeks after completion of Radiation Therapy]
Reflects the frequency of unplanned treatment and clinic absence as well as subject compliance of provider recommendations
Radiation Therapy (RT) Satisfaction Questionnaire [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)]
Adapted for radiation oncology setting from the CAHPS Cancer Center and EORTC Cancer Patient Satisfaction Surveys

Secondary Outcome Measures

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]
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 [following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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