EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options

Brief summary public domain (ClinicalTrials.gov)

The objective of this study is to improve the chemotherapy decision making process for Latinos with advanced gastrointestinal cancers. In this study Latinos who are considering 1st line chemotherapy for newly diagnosed advanced colorectal or pancreatic cancer will be randomized to usual care or to usual care supplemented by a Spanish/English language multimedia chemotherapy educational intervention. Primary informal caregivers will also be invited to participate. This research study is evaluating if a new set of educational materials will improve the treatment decision-making process for Latinos with advanced gastrointestinal cancers. This research study will involve about 154 patients and 154 caregivers.

Detailed description public domain (ClinicalTrials.gov)

There is growing evidence of racial/ethnic disparities in the quality of communication between oncologists and Latinos with cancer. These communication disparities are evidenced by gaps in Latino's understanding of their condition and treatment options, and by worse satisfaction with provider communication. Limited English proficiency and health literacy are very common among Latinos, yet few interventions have been developed to help Latino cancer patients better understand their condition and treatment options. In this study the investigators have partnered with Latino patients, providers, and researchers to develop a Spanish/English language intervention aimed at better informing Latinos with advanced gastrointestinal cancers about the risks and benefits of their chemotherapy options. Specifically, the intervention consists of a dual language, regimen-specific suite of videos and booklets explaining the most common chemotherapy options used to treat advanced colorectal cancer and advanced pancreatic cancer. The videos feature Latino patients describing their experiences on treatment, as well as clinicians describing factual information about treatment risks, benefits, and alternatives. In this study, self-identifying Hispanic/Latino patients with metastatic colorectal cancer, locally advanced and metastatic pancreatic cancer considering treatment with first line chemotherapy will be randomized to the usual care, or to usual care supplemented by access to the relevant chemotherapy educational materials. Caregivers will also be enrolled on the study. Participants will be surveyed at baseline, 2-weeks post-treatment initiation, 2-3 months post-treatment initiation, and 4-6 months post-treatment initiation regarding their understanding of chemotherapy risks and benefits, decisional conflict, and other metrics of informed decision-making.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks [8-12 weeks]. Count Of Participants, Participants. Chemotherapy Education Intervention Arm (n=2): 0; Usual Chemotherapy Education Arm (n=5): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Understanding of Chemotherapy Risks [2 weeks]. Count Of Participants, Participants. Chemotherapy Education Intervention Arm (n=3): 0; Usual Chemotherapy Education Arm (n=5): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey [2 weeks]. Mean, score on a scale (Standard Deviation). Chemotherapy Education Intervention Arm (n=3): 90 (17.3); Usual Chemotherapy Education Arm (n=5): 99 (2.24).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale. [2 weeks]. Mean, score on a scale (Standard Deviation). Chemotherapy Education Intervention Arm (n=3): 4 (0); Usual Chemotherapy Education Arm (n=1): 3 (0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Decisional Conflict as Measured by the 4-item SURE [2 weeks]. Mean, score on a scale (Standard Deviation). Chemotherapy Education Intervention Arm (n=3): 3.67 (.58); Usual Chemotherapy Education Arm (n=5): 3.8 (.45).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale [2 weeks]. Count Of Participants, Participants. Chemotherapy Education Intervention Arm (n=3): 2; Usual Chemotherapy Education Arm (n=5): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Decisional Regret [3 months]. Mean, score on a scale (Standard Deviation). Chemotherapy Education Intervention Arm (n=2): 15 (7); Usual Chemotherapy Education Arm (n=5): 7 (11).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Discussions About End-of-life Care Preferences With Healthcare Proxy and Care Team [3 months]. Count Of Participants, Participants. Chemotherapy Education Intervention Arm (n=0): 0; Usual Chemotherapy Education Arm (n=5): 5.