EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options
2 other identifiers
interventional
10
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2020
CompletedResults Posted
Study results publicly available
January 11, 2022
CompletedJanuary 11, 2022
December 1, 2021
2.2 years
July 9, 2018
August 25, 2021
December 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Accurate Understanding of Chemotherapy Benefits at 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 Outcomes (7)
Understanding of Chemotherapy Risks
2 weeks
Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey
2 weeks
Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.
2 weeks
Decisional Conflict as Measured by the 4-item SURE
2 weeks
Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale
2 weeks
- +2 more secondary outcomes
Study Arms (2)
Chemotherapy education intervention arm
EXPERIMENTALPatients 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.
Usual chemotherapy education arm
ACTIVE COMPARATORPatients 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.
Interventions
Standard chemo education will given per hospital guideline
Video, booklet, and website educational materials
Eligibility Criteria
You may qualify if:
- 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
- Caregivers of eligible patient participants
- Age ≥ 21
- English or Spanish proficient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (5)
Weeks JC, Catalano PJ, Cronin A, Finkelman MD, Mack JW, Keating NL, Schrag D. Patients' expectations about effects of chemotherapy for advanced cancer. N Engl J Med. 2012 Oct 25;367(17):1616-25. doi: 10.1056/NEJMoa1204410.
PMID: 23094723BACKGROUNDDegner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
PMID: 9505581BACKGROUNDMazor KM, Street RL Jr, Sue VM, Williams AE, Rabin BA, Arora NK. Assessing patients' experiences with communication across the cancer care continuum. Patient Educ Couns. 2016 Aug;99(8):1343-8. doi: 10.1016/j.pec.2016.03.004. Epub 2016 Mar 6.
PMID: 26979476BACKGROUNDLegare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.
PMID: 20705870BACKGROUNDBrehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
PMID: 12926578BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study closed early for slow accrual
Results Point of Contact
- Title
- Andrea Enzinger, MD
- Organization
- DFCI
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Enzinger, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 9, 2018
First Posted
July 27, 2018
Study Start
September 1, 2018
Primary Completion
November 27, 2020
Study Completion
November 27, 2020
Last Updated
January 11, 2022
Results First Posted
January 11, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share