Status:

COMPLETED

Improving Informed Consent for Palliative Chemotherapy

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

Patient-Centered Outcomes Research Institute

Alliance for Clinical Trials in Oncology

Conditions:

Metastatic Colorectal Cancer

Metastatic Pancreatic Cancer

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

Patients are routinely asked to sign an "informed consent" document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic m...

Detailed Description

Research indicates that many patients with advanced cancer receive palliative chemotherapy without sufficient understanding of its likely risks and benefits. In surveys, many patients receive palliati...

Eligibility Criteria

Inclusion

  • Diagnosis of advanced colorectal cancer with metastasis, locally advanced pancreatic cancer, or metastatic pancreatic cancer.
  • Is considering treatment with 1st line or 2nd line chemotherapy
  • Treating oncologist has recommended consideration of one or more of the regimens for which we have developed informed consent materials
  • Age ≥ 21
  • English proficiency (reading and speaking)

Exclusion

  • Significant delirium/dementia as judged by the treating physician
  • Isolated liver metastases being evaluated for curative resection
  • In addition, caregivers of eligible patients will also be eligible to participate in the caregivers assessments.

Key Trial Info

Start Date :

June 10 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 27 2017

Estimated Enrollment :

216 Patients enrolled

Trial Details

Trial ID

NCT02282722

Start Date

June 10 2015

End Date

September 27 2017

Last Update

October 14 2021

Active Locations (8)

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Page 1 of 2 (8 locations)

1

University of California at San Francisco

San Francisco, California, United States, 94143

2

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

3

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

4

Dana-Farber at Milford

Milford, Massachusetts, United States, 01757