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

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ClinicalTrials.gov Identifier: NCT03602885
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrea Enzinger, Dana-Farber Cancer Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Unresectable Pancreatic Cancer Metastatic Colorectal Cancer Behavioral: Usual chemotherapy education (CE) Behavioral: Chemotherapy education intervention (CEI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options - RCT of Usual Chemotherapy Educational Tools Versus Investigational Chemotherapy Educational Tools
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of participants with accurate understanding of chemotherapy benefits at 8-12 weeks [ Time Frame: 8-12 weeks ]
    Participants will be asked about their understanding of the likelihood of cure from chemotherapy.


Secondary Outcome Measures :
  1. 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. Responses will be summed for a composite knowledge score

  2. 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.

  3. 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 ranging from poor, fair, good, very good, or excellent. 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.


  4. 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.

  5. 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.


  6. 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.

  7. Discussions about end-of-life care preferences with healthcare proxy and care team [ Time Frame: 3 & 6 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602885


Contacts
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Contact: Andrea Enzinger, MD 617-582-7335 andrea_enzinger@dfci.harvard.edu

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Estrella Carballido Romero, MD    813-745-8459    Estrella.Carballido@moffitt.org   
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Kevan Hartshorn, MD    617-638-6428    Khartsho@bu.edu   
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Andrea Enzinger, MD    617-582-7335    andrea_enzinger@dfci.harvard.edu   
Principal Investigator: Andrea Enzinger, MD         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Jessica Belmonte, MD    505-272-4946    jbelmonte@salud.unm.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Muhammed Beg, MD    214-645-4673    Muhammad.Beg@UTSouthwestern.edu   
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andrea Enzinger, MD Dana-Farber Cancer Institute
Publications:
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Responsible Party: Andrea Enzinger, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03602885    
Other Study ID Numbers: 18-128
U54CA156732-06A1 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Enzinger, Dana-Farber Cancer Institute:
Gastrointestinal Cancer
cancer
palliative
chemotherapy
metastatic
colorectal
pancreatic
communication
informed consent
video
education
oncology
patient-centered
outcomes research
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases