Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audiovisual Intervention- Radiation Therapy Education | Experimental | Audiovisual video will be provided to the subjects as educational material. |
|
| Written Brochure- Radiation Therapy Education | Active Comparator | Written brochures will be provided to the subjects as educational material. |
|
| Audiovisual Intervention- Cancer Clinical Trials | Experimental | Audiovisual video will be provided to the subjects as educational material. |
|
| Written Brochure- Cancer Clinical Trials | Active Comparator | Written brochures will be provided to the subjects as educational material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audiovisual Intervention- Radiation Therapy Education | Other | A video with educational information will be shown regarding radiation therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | : 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Pilot Phase Inclusion Criteria:
Pilot Phase Exclusion Criteria:
Main Study Inclusion Criteria:
Main Study Exclusion Criteria:
Females with breast cancer, and males with prostate cancer.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Chesnakov, MPH | Contact | 646-317-4244 | cc4047@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Kachnic, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | Recruiting | Miami Beach | Florida | 33140 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2x2
Not provided
Not provided
Not provided
Not provided
| ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure | Other | Brochure with written information will be given to the subject regarding radiation therapy. |
|
| Audiovisual Intervention- Cancer Clinical Trials Education | Other | A video with educational information will be shown regarding cancer clinical trials. |
|
| NCI Taking Part in Cancer Research Studies Brochure | Other | Brochure with written information will be given to the subject regarding cancer clinical trials. |
|
| 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 | following completion of RT (4-6 weeks from enrollment for breast cancer, 4-9 weeks for prostate cancer), for up to 5 years |
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided