Improving Informed Consent for Palliative Chemotherapy

Completed · Not applicable

Conditions studied: Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT02282722

Run by

Dana-Farber Cancer Institute

People needed

216

Starts

2015-06-10

Expected to finish

2017-09-27

Last updated by the study team

2021-10-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber at Milford — Milford, Massachusetts, United States
• Dana-Farber at South Shore — South Weymouth, Massachusetts, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Novant Health — Winston-Salem, North Carolina, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.