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An Audiovisual Didactic Intervention to Increase Radiation Adherence in Latino Spanish Speaking Patients with Non-metastatic Breast or Prostate Cancer, ADELANTE Study
Trial Status: active
This phase II trial tests whether giving educational and audiovisual tools work to improve understanding, adherence, and satisfaction of radiation therapy in Latino Spanish speaking patients breast or prostate cancer that has not spread to other parts of the body (non-metastatic). An audiovisual didactic intervention may be an effective method to help Latino Spanish speaking patients learn about radiation therapy. This may increase their adherence to treatment.
Inclusion Criteria
PRODUCTION AND PILOT STUDY: Age 18 years or greater
PRODUCTION AND PILOT STUDY: Spanish speakers of Latino background as defined by the United States (U.S.) Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
PRODUCTION AND PILOT STUDY: Be currently undergoing treatment for breast or prostate cancer, or recently been treated
MAIN STUDY: Age 18 years or greater
MAIN STUDY: Spanish speakers of Latino background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
MAIN STUDY: Patients with non-metastatic prostate or breast cancer
MAIN STUDY: Histopathological proven diagnosis of prostate or breast cancer
MAIN STUDY: History and physical examination within 28 days prior to enrollment
MAIN STUDY: Karnofsky performance status 70 or greater
MAIN STUDY: For women of childbearing potential, pregnancy testing to be performed in accordance to institutional guidelines
MAIN STUDY: Plan to receive definitive, curative radiation. Patients planning to receive curative RT after upcoming adjuvant chemotherapy or induction hormonal therapy may enroll at re-consult “follow-up” visit
MAIN STUDY: Translation method must be documented
Exclusion Criteria
PRODUCTION AND PILOT STUDY: Patient with bilateral deafness and/or blindness
PRODUCTION AND PILOT STUDY: Patient with psychosis and/or dementia
MAIN STUDY: Patient with bilateral deafness and/or blindness
MAIN STUDY: Patient with psychosis and/or dementia
MAIN STUDY: Clinical or radiological evidence of metastatic disease
MAIN STUDY: Prior participation in any clinical trial
MAIN STUDY: Prior RT
MAIN STUDY: RT for sites other than breast or prostate
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05351424.
I. To determine the efficacy of a culturally and linguistically appropriate audiovisual didactic intervention (AVDI) in improving Latino-Spanish speaking (SS) patient radiotherapy (RT) adherence and satisfaction.
SECONDARY OBJECTIVE:
I. To determine the efficacy of a culturally and linguistically appropriate audiovisual didactic intervention (AVDI) in improving Latino-SS patient understanding and receptiveness of cancer clinical trials (clinical trials perceptivity).
Ia. To study the impact of clinical trial perceptivity on subsequent clinical trial enrollment.
TERTIARY OBJECTIVE:
I. To evaluate sociodemographic, culturolinguistic and modifiable healthcare system-level predictors of improved RT adherence, satisfaction and clinical trial perceptivity in Latino-SS patients.
OUTLINE:
PRODUCTION AND PILOT STUDY: Patients complete a focus group session (conducted in person or online) over 30 minutes on study.
MAIN STUDY:
FIRST RANDOMIZATION: Patients are randomized to 1 of 2 arms.
ARM I: Patients watch RT Knowledge AVDI video over 25 minutes prior to radiation therapy planning.
ARM II: Patients read an educational brochure over 25 minutes prior to radiation therapy planning.
SECOND RANDOMIZATION: Patients are randomized to 1 of 2 arms.
ARM III: Patients watch Clinical Trials AVDI video over 25 minutes at final clinic visit of radiation therapy.
ARM IV: Patients read an educational brochure over 25 minutes at final clinic visit of radiation therapy.
After completion of radiation therapy, patients are followed for up to 5 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
