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.
Research indicates that many patients with advanced cancer receive palliative chemotherapy without sufficient understanding of its likely risks and benefits. In surveys, many patients receive palliative chemotherapy without expressing an understanding that cure is unlikely. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
216
Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.
The enrolling site's institutional standard-of-care informed consent materials.
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
Number of Patients With Accurate Understanding of Chemotherapy Benefits
Patients were asked "How likely do you think that chemotherapy is to cure your cancer?" with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of "not at all likely" was considered accurate. All other responses, including don't know, were considered inaccurate.
Time frame: 3 months
Number of Patients With Accurate Understanding of Chemotherapy Risks
Patients were asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration, with separate items for nausea/vomiting, diarrhea, neuropathy, and hair loss. Patients' responses were correlated to the known side effect profile of their chemotherapy regimen and coded as accurate or inaccurate.
Time frame: 2 weeks
Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy
Patients were asked "according to your doctor, what is the goal of the chemotherapy?" with the ability to choose any/all of the following response options: cure, control cancer growth, alleviate symptoms, prolong life, or other. Selecting either control cancer growth, and/or alleviate symptoms, and/or prolong life were defined as accurate understanding; "to cure" was considered inaccurate.
Time frame: 2 weeks
Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores
Decisional Conflict was assessed by a modified version of the 4 item SURE instrument of Legare at al which assesses whether patients 1) are sure of the best treatment option, 2) know the risks and benefits of their treatment options, 3) are clear about which risks and benefits matter to them, and 4) whether they have sufficient support to make their treatment decision. We expanded items 2 and 3 into four separate items assessing risks and benefits individually. Responses were summed, resulting in a scale of 0-6, where 0 indicates maximum conflict and 6 indicates no conflict
Time frame: 2 weeks
Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process
Achievement of preferred role in decision-making was assessed by the Control Preferences Scale; patients indicate the role they played in their treatment decision which is compared to their preferred role (assessed at baseline).
Time frame: 2 weeks
Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores
Satisfaction with communication during treatment decision-making process was assessed via 5 items from the Patient Assessment of Cancer Communication Experiences (PACE). Scores were averaged ("does not apply" excluded), creating a score of 1 to 4, with 4 being the most satisfied.
Time frame: 2 weeks
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team
Time frame: 3 months
Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale
Decisional Regret was assessed at the 3-month survey using Brehaut's 5-item decisional regret scale, with scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret.
Time frame: 3 months
Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment
Emotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable.
Time frame: 3 months
Patient-Reported Prognostic Understanding in Median Years
Prognostic understanding was assessed by asking patients about their understanding of the prognosis of the typical patient with their condition (\<1 year, 1-2 years, 2- 3 years, 3-5 years, 5-10 years, \>10 years). This measure was adapted from the CANCORS trial.
Time frame: 3 months
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