Improving Informed Consent for Palliative Chemotherapy

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.