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

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

Tracking Information

• First Submitted Date: March 31, 2022
• First Posted Date: April 28, 2022
• Last Update Posted Date: July 13, 2023
• Actual Study Start Date: May 3, 2022
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2022)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 24, 2022)

• 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.
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc
• Official Title: Audiovisual Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

2x2

Masking: None (Open Label)
Primary Purpose: Health Services Research

Condition

• Breast Cancer Invasive
• Prostate Cancer

Intervention

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

Study Arms

• Experimental: Audiovisual Intervention- Radiation Therapy Education
  Audiovisual video will be provided to the subjects as educational material.
  Intervention: Other: Audiovisual Intervention- Radiation Therapy Education
• Active Comparator: Written Brochure- Radiation Therapy Education
  Written brochures will be provided to the subjects as educational material.
  Intervention: Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure
• Experimental: Audiovisual Intervention- Cancer Clinical Trials
  Audiovisual video will be provided to the subjects as educational material.
  Intervention: Other: Audiovisual Intervention- Cancer Clinical Trials Education
• Active Comparator: Written Brochure- Cancer Clinical Trials
  Written brochures will be provided to the subjects as educational material.
  Intervention: Other: NCI Taking Part in Cancer Research Studies Brochure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 24, 2022): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: females with breast cancer, males with prostate cancer

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Oscar Padilla, MD; 212-305-7077; op2237@cumc.columbia.edu

Contact: Mariamne Reyna; 646-317-4244; mo2213@cumc.columbia.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05351424
• Other Study ID Numbers: AAAT2490
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lisa A. Kachnic, Columbia University
• Original Responsible Party: Same as current
• Current Study Sponsor: Columbia University
• Original Study Sponsor: Same as current
• Collaborators: Varian Medical Systems

Investigators

• Principal Investigator: Lisa Kachnic, MD; Columbia University

• PRS Account: Columbia University
• Verification Date: July 2023