Breast Cancer InvasiveADELANTENCT05351424
AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc
A study testing Audiovisual Intervention- Radiation Therapy Education, ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure and Audiovisual Intervention- Cancer Clinical Trials Education in people with Breast Cancer Invasive and Prostate Cancer, run by Columbia University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Invasive, Prostate Cancer
- What is being tested?
- Audiovisual Intervention- Radiation Therapy Education, ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure and Audiovisual Intervention- Cancer Clinical Trials Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 May 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Irina Bakura-Caso, (305) 674-2625, Irina.BakuraCaso@msmc.com
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Audiovisual Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology
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.
Read the 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.
- Conditions
- Breast Cancer Invasive, Prostate Cancer
- Being tested
- 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
- Keywords
- breast cancer, prostate cancer, audiovisual intervention, Spanish-speaking, focus group, treatment experience, patient education, radiotherapy adherence, cancer trial participation
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual Intervention- Radiation Therapy EducationOther
A video with educational information will be shown regarding radiation therapy.
ASTRO Radiation Therapy for Breast or Prostate Cancer BrochureOther
Brochure with written information will be given to the subject regarding radiation therapy.
Audiovisual Intervention- Cancer Clinical Trials EducationOther
A video with educational information will be shown regarding cancer clinical trials.
NCI Taking Part in Cancer Research Studies BrochureOther
Brochure with written information will be given to the subject regarding cancer clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual Intervention- Radiation Therapy Education | Experimental | Audiovisual video will be provided to the subjects as educational material. Receives: Other: Audiovisual Intervention- Radiation Therapy Education |
| Written Brochure- Radiation Therapy Education | Active comparator | Written brochures will be provided to the subjects as educational material. Receives: Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure |
| Audiovisual Intervention- Cancer Clinical Trials | Experimental | Audiovisual video will be provided to the subjects as educational material. Receives: Other: Audiovisual Intervention- Cancer Clinical Trials Education |
| Written Brochure- Cancer Clinical Trials | Active comparator | Written brochures will be provided to the subjects as educational material. Receives: Other: NCI Taking Part in Cancer Research Studies Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: : 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
Measured: 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
Measured: 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 outcomes (2)
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.
Measured: 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
Measured: following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start3 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Lisa A. Kachnic, Columbia University
- Investigators
- Lisa Kachnic, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351424
- Sponsor's protocol ID
- AAAT2490
- Acronym
- ADELANTE
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovisual Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology
- ClinicalTrials.gov ID
- NCT05351424
- Acronym / sponsor ID
- ADELANTE / AAAT2490
- Conditions
- Breast Cancer Invasive, Prostate Cancer
- Keywords
- breast cancer, prostate cancer, audiovisual intervention, Spanish-speaking, focus group, treatment experience, patient education, radiotherapy adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 3 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2
| Arm | Type | Receives |
|---|---|---|
| Audiovisual Intervention- Radiation Therapy Education | Experimental | Other: Audiovisual Intervention- Radiation Therapy EducationAudiovisual video will be provided to the subjects as educational material. |
| Written Brochure- Radiation Therapy Education | Active comparator | Other: ASTRO Radiation Therapy for Breast or Prostate Cancer BrochureWritten brochures will be provided to the subjects as educational material. |
| Audiovisual Intervention- Cancer Clinical Trials | Experimental | Other: Audiovisual Intervention- Cancer Clinical Trials EducationAudiovisual video will be provided to the subjects as educational material. |
| Written Brochure- Cancer Clinical Trials | Active comparator | Other: NCI Taking Part in Cancer Research Studies BrochureWritten brochures will be provided to the subjects as educational material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual Intervention- Radiation Therapy EducationA video with educational information will be shown regarding radiation therapy. | Other | Audiovisual Intervention- Radiation Therapy Education |
| ASTRO Radiation Therapy for Breast or Prostate Cancer BrochureBrochure with written information will be given to the subject regarding radiation therapy. | Other | Written Brochure- Radiation Therapy Education |
| Audiovisual Intervention- Cancer Clinical Trials EducationA video with educational information will be shown regarding cancer clinical trials. | Other | Audiovisual Intervention- Cancer Clinical Trials |
| NCI Taking Part in Cancer Research Studies BrochureBrochure with written information will be given to the subject regarding cancer clinical trials. | Other | Written Brochure- Cancer Clinical Trials |
Primary outcome
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.
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
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Kachnic, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual Intervention- Radiation Therapy Education, ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure and Audiovisual Intervention- Cancer Clinical Trials Education in people with Breast Cancer Invasive and Prostate Cancer, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Chesnakov, MPH (646-317-4244, cc4047@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.