Breast Cancer Invasive, Prostate Cancer
Conditions
Keywords
breast cancer, prostate cancer, audiovisual intervention, Spanish-speaking, focus group, treatment experience, patient education, radiotherapy adherence, cancer trial participation
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.
Interventions
OTHERAudiovisual Intervention- Radiation Therapy Education
A video with educational information will be shown regarding radiation therapy.
OTHERASTRO Radiation Therapy for Breast or Prostate Cancer Brochure
Brochure with written information will be given to the subject regarding radiation therapy.
OTHERAudiovisual Intervention- Cancer Clinical Trials Education
A video with educational information will be shown regarding cancer clinical trials.
OTHERNCI Taking Part in Cancer Research Studies Brochure
Brochure with written information will be given to the subject regarding cancer clinical trials.
Sponsors
Columbia University
Varian Medical Systems
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
2x2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Therapy (RT) Knowledge Questionnaire | : 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Trials Perceptivity Questionnaire | 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 | 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 |
Countries
United States
Contacts
CONTACTChristina Chesnakov, MPH
PRINCIPAL_INVESTIGATORLisa Kachnic, MD
Columbia University
Outcome results
None listed