AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc
Conditions
Breast Cancer Invasive, Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Mariamne Reyna
- 646-317-4244
- [email protected]
Principal Investigator
- Lisa Kachnic, MD
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
Study Plan
Audiovisual Intervention- Radiation Therapy Education
EXPERIMENTAL
Audiovisual video will be provided to the subjects as educational material.
OTHER:
Audiovisual Intervention- Radiation Therapy EducationDescription:
A video with educational information will be shown regarding radiation therapy.
Written Brochure- Radiation Therapy Education
ACTIVE_COMPARATOR
Written brochures will be provided to the subjects as educational material.
OTHER:
ASTRO Radiation Therapy for Breast or Prostate Cancer BrochureDescription:
Brochure with written information will be given to the subject regarding radiation therapy.
Audiovisual Intervention- Cancer Clinical Trials
EXPERIMENTAL
Audiovisual video will be provided to the subjects as educational material.
OTHER:
Audiovisual Intervention- Cancer Clinical Trials EducationDescription:
A video with educational information will be shown regarding cancer clinical trials.
Written Brochure- Cancer Clinical Trials
ACTIVE_COMPARATOR
Written brochures will be provided to the subjects as educational material.
OTHER:
NCI Taking Part in Cancer Research Studies BrochureDescription:
Brochure with written information will be given to the subject regarding cancer clinical trials.
Outcome Measures
Primary Outcome Measures
Radiation Therapy (RT) Knowledge Questionnaire
Radiation Therapy (RT) Adherence Score
Radiation Therapy (RT) Satisfaction Questionnaire
Secondary Outcome Measures
Clinical Trials Perceptivity Questionnaire
Clinical trial enrollment
Timeline
Last Updated
June 7, 2024Start Date
April 28, 2022Today
May 12, 2025Completion Date ( Estimated )
December 31, 2026
Sponsors of this trial
Lead Sponsor
Columbia UniversityCollaborating Sponsors
Varian Medical Systems