Study Results
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View full resultsBasic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2015-06-10
2017-09-27
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Usual informed consent
Study participant will receive usual, standard-of-care informed consent for chemotherapy materials.
Usual, standard-of-care informed consent for chemotherapy
The enrolling site's institutional standard-of-care informed consent materials.
Investigational informed consent
Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team.
Investigational informed consent for chemotherapy
Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.
Interventions
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Investigational informed consent for chemotherapy
Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.
Usual, standard-of-care informed consent for chemotherapy
The enrolling site's institutional standard-of-care informed consent materials.
Eligibility Criteria
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Inclusion Criteria
* 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
* Isolated liver metastases being evaluated for curative resection
In addition, caregivers of eligible patients will also be eligible to participate in the caregivers assessments.
21 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Alliance for Clinical Trials in Oncology
OTHER
National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Andrea Enzinger
Chief, Division of Population Sciences
Principal Investigators
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Andrea Enzinger, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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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
Countries
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References
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Weeks JC, Catalano PJ, Cronin A, Finkelman MD, Mack JW, Keating NL, Schrag D. Patients' expectations about effects of chemotherapy for advanced cancer. N Engl J Med. 2012 Oct 25;367(17):1616-25. doi: 10.1056/NEJMoa1204410.
Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
Mazor KM, Street RL Jr, Sue VM, Williams AE, Rabin BA, Arora NK. Assessing patients' experiences with communication across the cancer care continuum. Patient Educ Couns. 2016 Aug;99(8):1343-8. doi: 10.1016/j.pec.2016.03.004. Epub 2016 Mar 6.
Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.
Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
Enzinger AC, Uno H, McCleary N, Frank E, Sanoff H, Van Loon K, Matin K, Bullock A, Cronin C, Cibotti H, Bagley J, Schrag D. Effectiveness of a Multimedia Educational Intervention to Improve Understanding of the Risks and Benefits of Palliative Chemotherapy in Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1265-1270. doi: 10.1001/jamaoncol.2020.1921.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CE-1304-6517
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
15-143
Identifier Type: -
Identifier Source: org_study_id