Moffitt logo

Clinical Trials Search

Clinical Trial 19860

Cancer Type: Gastrointestinal Tumor
Interventions:

Study Type: Health Services Research
Phase of Study: N/A
Investigators:

  • Estrella Carballido Romero

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

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.

Objective

Objective 1: Determine the impact of a multimedia chemotherapy educational intervention on understanding of chemotherapy risks and benefits among Latinos with advanced gastrointestinal cancers and their caregivers. Objective 2: Determine the impact of the multimedia chemotherapy educational intervention on communication satisfaction and quality of informed decision-making about palliative chemotherapy among Latinos with advanced GI cancers. Objective 3: Characterize Latino patients' & caregivers financial well-being, financial strain, and occupational outcomes over the first 6 months of palliative chemotherapy. Explore relationships between financial strain and patients' quality of life and symptoms, and caregiver well-being.

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
  • Participants 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 participants: Participants with oligometastatic disease who have a definitive plan for curative surgical resection are not eligible.
  • Significant delirium/dementia as judged by the treating oncologist