Improving Informed Consent for Palliative Chemotherapy



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:10/24/2018
Start Date:December 2013
End Date:September 27, 2017

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Improving Informed Consent for Palliative Chemotherapy: Development of a Regimen-Specific Multi-Media Informed Consent Library To Promote Patient-Centered Decision-Making About Treatment of Advanced Gastrointestinal Cancers

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 moment to equip patients with information they need to make truly
informed medical decisions, many patients and caregivers note that these conversations are
less useful than they could be. The informed consent process and its associated documents
suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials
focus on individual drugs instead of regimens; 3) information is presented in written instead
of alternative written/audiovisual format; and 4) the patient perspective is lacking.

The overarching objective of this project is to develop a library of communication tools for
the most common chemotherapy regimens used to treat advanced gastrointestinal cancers. Tools
will include video clips and written documents that can be readily distributed, modified, and
customized. This toolkit will be crafted in collaboration with oncologists and patients
living with gastrointestinal cancer and improves upon existing resources in several ways: 1)
balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3)
use of both written and video format, and 4) inclusion of the patient perspective (e.g. video
clips of patients describing their experience). A panel of oncologist and patient
stakeholders will evaluate the acceptability of the tools. The investigators will then
conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves
the quality of informed consent for palliative chemotherapy. If effective, the tools will be
amenable to broad dissemination via patient accessible cancer education websites and oncology
clinics.

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 palliative chemotherapy without expressing an understanding that cure is unlikely.

The root of this problem is undoubtedly complex, but may relate to gaps in communication and
patient education about the risks and benefits of treatment. 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 moment to
equip patients with information they need to make truly informed medical decisions, many
patients and caregivers note that these conversations are less useful than they could be. The
informed consent process and its associated documents suffer several limitations: 1) risks
are emphasized over benefits; 2) educational materials focus on individual drugs instead of
regimens; 3) information is presented in written instead of alternative written/audiovisual
format; and 4) the patient perspective is lacking.

The overarching objective of this trial is to test a suite of patient-centered videos and
booklets to support informed consent for common chemotherapy regimens used to treat advanced
gastrointestinal cancers. In this study, patients with metastatic colorectal cancer, locally
advanced and metastatic pancreatic cancer considering treatment with first or second-line
palliative chemotherapy were randomized to the usual process of chemotherapy informed
consent, or usual care supplemented by access to the appropriate investigational chemotherapy
informed consent video and booklet. Patients were surveyed at baseline, 2-weeks
post-treatment initiation, and 3 months regarding their understanding of chemotherapy risks
and benefits, decisional conflict, and other metrics of informed decision-making.

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
8
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-8301
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-2100
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Milford, Massachusetts 01757
Phone: 508-488-3700
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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San Francisco, California 94143
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101 Columbian Street
South Weymouth, Massachusetts 02190
Phone: 781-624-4800
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South Weymouth, MA
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2025 Frontis Plaza Boulevard
Winston-Salem, North Carolina 27103
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