AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient with bilateral deafness and/or blindness
Patient with psychosis and/or dementia
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
Trial design
Design model
Factorial
Treatments tested in this trial
Audiovisual Intervention- Radiation Therapy Education
Other interventionA video with educational information will be shown regarding radiation therapy.
ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure
Other interventionBrochure with written information will be given to the subject regarding radiation therapy.
Audiovisual Intervention- Cancer Clinical Trials Education
Other interventionA video with educational information will be shown regarding cancer clinical trials.
NCI Taking Part in Cancer Research Studies Brochure
Other interventionBrochure with written information will be given to the subject regarding cancer clinical trials.
Treatment groups
194 Participants
are divided into 4 treatment groupsGroup A: Audiovisual Intervention- Radiation Therapy EducationExperimental treatment 1 intervention
Group B: Written Brochure- Radiation Therapy EducationActive comparator 1 intervention
Group C: Audiovisual Intervention- Cancer Clinical TrialsExperimental treatment 1 intervention
Group D: Written Brochure- Cancer Clinical TrialsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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)2
Radiation Therapy (RT) Adherence Score
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 Therapy3
Radiation Therapy (RT) Satisfaction Questionnaire
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 outcomes
1
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.
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 e2
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
Time frame
following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Varian Medical Systems
Collaborator
Source ClinicalTrials.gov