Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
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 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.


Options:
A: Inclusion Criteria:

* Adult (at least 18 year old) cancer patients connected to the Department of Oncology, Copenhagen University Hospital
* Patients who want to spend as much time as possible in their own homes supported by an SPT
* Patients with incurable cancer
* Patients with no or limited antineoplastic treatment options or patients who resign antineoplastic treatment
* Patients living in the Capital Region
* Written informed consent

Exclusion Criteria:

* Patients who have already been referred to an SPT
* Hospitalized patients who are not judged capable of being discharged home
* Patients who are admitted to other hospitals
* Patients who do not speak Danish well enough to answer the questionnaires
* Patients who are considered incapable of cooperating in the trial
B: Inclusion Criteria:

* age 18 years or older
* actively involved in the life of the patient receiving care; and
* functionally fluent in English or Spanish.

Exclusion Criteria:

* discharge plan in place for patient before day 4
* previously received palliative care
* patient placed on extracorporeal membrane oxygenation (ECMO)
* no prior admission to ICU for same hospitalization
C: 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.
D: Inclusion Criteria:

* Mechanically ventilated ≥ 7 days
* Mechanically ventilated without \> 96 hour interruption
* Age ≥ 21 years
* ICU MD does not expect patient will die within 72 hours
* ICU MD does not expect patient will be liberated from the ventilator within 72 hours.

Exclusion Criteria:

* Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for \> 7 days before transfer
* Chronic Neuromuscular (NM) Disease
* Trauma
* Burn
* Previous palliative care consultation in this hospitalization
* No family or other surrogate decision-maker
* Family not available
* Surrogate lacks English proficiency
* Physician refused permission for research staff to approach the family

Answer: C