N/A
Completed N=10
EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options
Source: ClinicalTrials.gov NCT03602885 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks — 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks |
0; 0 | — |
| SECONDARY Understanding of Chemotherapy Risks |
0; 3 | — |
| SECONDARY Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey |
90; 99 | — |
| SECONDARY Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale. |
4; 3 | — |
| SECONDARY Decisional Conflict as Measured by the 4-item SURE |
3.67; 3.8 | — |
| SECONDARY Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale |
2; 3 | — |
| SECONDARY Decisional Regret |
15; 7 | — |
| SECONDARY Discussions About End-of-life Care Preferences With Healthcare Proxy and Care Team |
0; 5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03602885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.