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

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ClinicalTrials.gov Identifier: NCT05351424
Recruitment Status : Recruiting
First Posted : April 28, 2022
Last Update Posted : July 13, 2023
Sponsor:
Collaborator:
Varian Medical Systems
Information provided by (Responsible Party):
Lisa A. Kachnic, Columbia University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2
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
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Clinical Trials

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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) ]
    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.

  2. Radiation Therapy (RT) Adherence Score [ Time Frame: 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

  3. 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) ]
    Adapted for radiation oncology setting from the CAHPS Cancer Center and EORTC Cancer Patient Satisfaction Surveys


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females with breast cancer, males with prostate cancer
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05351424


Contacts
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Contact: Oscar Padilla, MD 212-305-7077 op2237@cumc.columbia.edu
Contact: Mariamne Reyna 646-317-4244 mo2213@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Varian Medical Systems
Investigators
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Principal Investigator: Lisa Kachnic, MD Columbia University
More Information
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Responsible Party: Lisa A. Kachnic, Professor and Chair, Department of Radiation Oncology, Columbia University
ClinicalTrials.gov Identifier: NCT05351424    
Other Study ID Numbers: AAAT2490
First Posted: April 28, 2022    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa A. Kachnic, Columbia University:
breast cancer
prostate cancer
audiovisual intervention
Spanish-speaking
focus group
 treatment experience
patient education
radiotherapy adherence
cancer trial participation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases