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

December 21, 2021 updated by: Andrea Enzinger, Dana-Farber Cancer Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Chemotherapy education intervention arm
Patients randomized to the chemotherapy education intervention (CEI) arm will be given regimen specific written and video chemotherapy educational materials developed by the study team. The treating oncologist will identify which chemotherapy regimen(s) are being considered, in order to select the appropriate chemotherapy educational tool(s) to give the patient. The patient may be given more than one CEI tool if they are considering more than one regimen. Patients randomized to the intervention arm may receive the intervention in addition to OR in place of the standard institutionally approved chemotherapy information sheets (both are acceptable); this is at the discretion of the treating site or the treating physician.
Behavioral: Chemotherapy education intervention (CEI)
Video, booklet, and website educational materials
ACTIVE_COMPARATOR: Usual chemotherapy education arm
Patients randomized to the usual chemotherapy education (CE) arm will undergo the standard institutional practice of chemotherapy education. The oncologist may also choose to give the patient the institutionally approved chemotherapy information sheets according to site-specific policies and clinical practice.
Behavioral: Usual chemotherapy education (CE)
Standard chemo education will given per hospital guideline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks
Time Frame: 8-12 weeks
Participants were asked how likely they thought chemotherapy was to cure their cancer (response options: very likely, somewhat likely, a little likely, not at all likely, don't know). Not at all likely is considered accurate, all other responses are considered inaccurate.
8-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Understanding of Chemotherapy Risks
Time Frame: 2 weeks
Participants will be asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration (fatigue, nausea/vomiting, neuropathy, myalgias/arthralgias, hair loss, diarrhea). Patients' responses will be correlated to the known side effect profile of their chemotherapy regimen. Participants who are accurate on all questions will be considered to have accurate knowledge.
2 weeks
Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey
Time Frame: 2 weeks
Communication satisfaction: will be assessed by five communication satisfaction items from the cancer specific version of the Consumer Assessment for Health Providers and Systems (CAHPS): "How often did your doctors...listen carefully to you, explain things in a way you could understand, give you as much information as you wanted about your cancer treatments, encourage you to ask all the questions you had, and treat you with courtesy and respect?" Options: always, usually, sometimes, or never. Patient responses will be summed, with possible score of 0-100 (with higher scores indicating better communication). Patients will complete this assessment at the post-decision and 3-month survey, but our primary analysis for this outcome will consider the post-decision assessment because it is most proximate to chemotherapy decision-making and exposure to the intervention.
2 weeks
Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.
Time Frame: 2 weeks

At the post-decision assessment, patients in the intervention arm will be asked to rate their satisfaction with the investigational chemotherapy educational materials with the following item: "Please think about the booklet, video, and website together. How would you rate them as a whole?" with response options on a 5-point likert scale where higher scores indicate greater satisfaction. (range: 1-5, 5 is best) Patients could alternatively choose "don't know, or I did not review them."

Patients in the control arm will be asked to rate chemotherapy educational materials they were given with the same response options.
2 weeks
Decisional Conflict as Measured by the 4-item SURE
Time Frame: 2 weeks
Decisional conflict will be assessed by the SURE test of Legare et al, which includes 4 items assessing whether patients feel (yes/no) 1) sure of their decision, 2) understand benefits and risks of each option, 3) are clear about which risks and benefits matter most to them, and 4) if they have enough support for the decision. Scores range from 0-4, with lower scores indicating more decisional conflict. Scores of 3 or less are considered positive for the presence of decisional conflict.
2 weeks
Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale
Time Frame: 2 weeks

Whether patients achieved their preferred role in decision-making will be assessed by the two-item Degner's Control Preferences Scale (CPS) which assesses and compares patients' preferred role (baseline) and achieved role (post-decision) decision-making.

At baseline patients are asked so select among 5 options their preferred decision-making role - with two options representing an active role, two representing a passive role, and one representing shared decision-making. At post-decision, patients indicate what role they played in their treatment decision, with 5 similarly worded options representing active, passive, or shared decision-making.

Patients whose preferred decision-making role (passive, shared, or active) matches their achieved role (passive, shared, or active) will be considered to have achieved their preferred role in their treatment decision.
2 weeks
Decisional Regret
Time Frame: 3 months
Patient decisional regret will be assessed with Brehaut's 5-item Decisional Regret Scale. In this scale patients respond to a series of 5 questions about their recent treatment decision, with response options ranging from 1 (strongly agree) to 5 (strongly agree) on a 5-point likert scale. Two items are reverse-code, averaged, and converted to a 0-100 scale by subtracting 1 and multiplying by 25. A score of 100 indicates maximal regret.
3 months
Discussions About End-of-life Care Preferences With Healthcare Proxy and Care Team
Time Frame: 3 months
At 8-12 weeks and 6 months, patients will indicate whether they have designated a healthcare proxy, or discussed end-of-life wishes with their physicians or proxy.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dana-Farber Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-128
  • U54CA156732-06A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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