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Summary

for people ages 21 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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 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. 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.

Official 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

Details

A substantial body of research indicates that many patients with incurable cancer harbor significant misconceptions about the benefits of palliative chemotherapy. 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 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. 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.

Keywords

Metastatic Colorectal Cancer cancer palliative chemotherapy metastatic colorectal communication informed consent video education oncology patient-centered outcomes research

Eligibility

You can join if…

Open to people ages 21 years and up

  • 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 CAN'T join 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.

Locations

  • Novant Health completed
    Winston-Salem, North Carolina, 27103, United States
  • University of North Carolina at Chapel Hill in progress, not accepting new patients
    Chapel Hill, North Carolina, 27599, United States
  • Virginia Commonwealth University in progress, not accepting new patients
    Richmond, Virginia, 23284, United States
  • Dana-Farber at Milford accepting new patients
    Milford, Massachusetts, 01757, United States
  • Beth Israel Deaconess Medical Center accepting new patients
    Boston, Massachusetts, 02215, United States
  • Dana-Farber Cancer Institute accepting new patients
    Boston, Massachusetts, 02215, United States
  • Dana-Farber at South Shore accepting new patients
    South Weymouth, Massachusetts, 02190, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dana-Farber Cancer Institute
ID
NCT02282722
Study Type
Interventional
Last Updated
April 1, 2017