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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
Investigator (PI): Schrag, Deborah
Performing Organization (PO): (Current): Dana-Farber Cancer Institute, Gastrointestinal Cancer Treatment Center / (617) 632-4500
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/CE-1304-6517
Funding: Total Award Amount: $1,010,164
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: A substantial body of research indicates that many patients with incurable cancer harbor significant misconceptions about the benefits of palliative chemotherapy. In a large population-based cohort of patients with metastatic colorectal and lung cancers, we found that the vast majority failed to recognize that chemotherapy was unlikely to cure their disease. This misunderstanding indicates pervasive deficiencies in how cancer patients are informed about fundamentals of their disease and treatment options. The root of this problem is undoubtedly complex, but likely relates to deficiencies in patient-doctor communication about incurable cancer. At the outset of treatment, it is important for oncologists to establish trust, a strong rapport, and convey hope even when prognosis is poor. As a result, oncologists may describe difficult information about prognosis and the limitations of chemotherapy in a telescopic or vague manner that makes it difficult for patients to understand what lies ahead. While this approach may initially provide solace, downstream it can impede patients' ability to make truly informed choices about how to allocate their limited time and energy. 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 five most common chemotherapy regimens used to treat metastatic colorectal cancer. 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. We 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.
MeSH Terms:
  • Antineoplastic Agents /therapeutic use
  • Attitude to Health
  • Communication
  • * Decision Making
  • * Decision Support Systems, Clinical
  • Drug Therapy /*methods
  • Gastrointestinal Neoplasms /*drug therapy
  • Humans
  • * Informed Consent
  • Multimedia
  • Palliative Care /*methods
  • Patient Education as Topic /*methods
  • Patient Participation
  • Patient-Centered Care
  • Physician-Patient Relations
  • Prognosis
  • Truth Disclosure
Country: United States
State: Massachusetts
Zip Code: 02215
UI: 20143516
CTgovId: NCT02282722
Project Status: Completed
Record History: ('2017: Project extended to 2018.',)