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



Status:Recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:2/8/2019
Start Date:September 1, 2018
End Date:July 31, 2024
Contact:Andrea Enzinger, MD
Email:andrea_enzinger@dfci.harvard.edu
Phone:617-582-7335

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EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options - RCT of Usual Chemotherapy Educational Tools Versus Investigational Chemotherapy Educational Tools

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.

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.

Patient Inclusion Criteria:

- Self-identify as Hispanic/Latino

- Has been diagnosed with metastatic colorectal cancer (mCRC) OR locally advanced
pancreatic cancer (LAPC) OR metastatic pancreatic cancer (mPC) AND is making a
decision regarding treatment with 1st line palliative chemotherapy

- Treating oncologist has recommended consideration of one or more of the regimens for
which we have developed chemotherapy educational (CEI) toolkits

- For mCRC: FOLFOX, FOLFOX + bevacizumab, FOLFIRI, FOLFIRI + bevacizumab

- For LAPC or mPC: FOLFIRINOX, Gemcitabine, or Gemcitabine + nab-paclitaxel

- Patients who are also considering treatment on a clinical trial of one of these
regimens +/- an investigational agent would still be eligible, so long as the
treating MD believes to the content of the CEI to be relevant to the trial
regimen.

- Planning to receive treatment at the enrolling site

- Age ≥ 21

- English or Spanish proficient

Caregiver Inclusion Criteria:

- Caregivers of eligible patient participants

- Age ≥ 21

- English or Spanish proficient

Exclusion Criteria:

- For mCRC patients: Patients with oligometastatic disease who have a definitive plan
for curative surgical resection are not eligible.

- Significant delirium/dementia as judged by the treating oncologist
We found this trial at
5
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Andrea Enzinger, MD
Phone: 617-582-7335
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Phone: 813-745-4673
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Boston, Massachusetts 02118
Phone: 617-638-6428
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-645-4673
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Tampa, Florida 33612
Phone: 813-745-4380
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Tampa, FL
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