Improving Informed Consent for Palliative Chemotherapy

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Patients With Accurate Understanding of Chemotherapy Benefits [3 months]. Count Of Participants, Participants. Accurate: Patient Usual Care Arm (n=71): 39; Patient Investigational Care Arm (n=73): 39. Inaccurate: Patient Usual Care Arm (n=71): 30; Patient Investigational Care Arm (n=73): 31. Did not answer: Patient Usual Care Arm (n=71): 2; Patient Investigational Care Arm (n=73): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Patients With Accurate Understanding of Chemotherapy Risks [2 weeks]. Count Of Participants, Participants. Inaccurate: Patient Usual Care Arm (n=79): 47; Patient Investigational Care Arm (n=75): 33. Accurate: Patient Usual Care Arm (n=79): 31; Patient Investigational Care Arm (n=75): 41. Unknown/missing: Patient Usual Care Arm (n=79): 1; Patient Investigational Care Arm (n=75): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy [2 weeks]. Count Of Participants, Participants. Inaccurate: Patient Usual Care Arm (n=79): 10; Patient Investigational Care Arm (n=75): 9. Accurate: Patient Usual Care Arm (n=79): 68; Patient Investigational Care Arm (n=75): 65. Unknown/missing: Patient Usual Care Arm (n=79): 1; Patient Investigational Care Arm (n=75): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores [2 weeks]. Mean, units on a scale (Standard Deviation). Patient Usual Care Arm (n=79): 5.2 (1.7); Patient Investigational Care Arm (n=75): 5.5 (1.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process [2 weeks]. Count Of Participants, Participants. No: Patient Usual Care Arm (n=79): 48; Patient Investigational Care Arm (n=75): 39. Yes: Patient Usual Care Arm (n=79): 30; Patient Investigational Care Arm (n=75): 35. Unknown/missing: Patient Usual Care Arm (n=79): 1; Patient Investigational Care Arm (n=75): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores [2 weeks]. Mean, units on a scale (Standard Deviation). Patient Usual Care Arm (n=79): 3.6 (0.5); Patient Investigational Care Arm (n=75): 3.7 (0.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team [3 months]. Count Of Participants, Participants. No: Patient Usual Care Arm (n=71): 60; Patient Investigational Care Arm (n=73): 55. Yes: Patient Usual Care Arm (n=71): 10; Patient Investigational Care Arm (n=73): 16. Unknown/missing: Patient Usual Care Arm (n=71): 1; Patient Investigational Care Arm (n=73): 2.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale [3 months]. Mean, units on a scale (Standard Deviation). Patient Usual Care Arm (n=71): 79.6 (19.3); Patient Investigational Care Arm (n=73): 84.7 (14.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment [3 months]. Mean, units on a scale (Standard Deviation). Patient Usual Care Arm (n=71): 16.5 (4.6); Patient Investigational Care Arm (n=73): 17.3 (4.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Patient-Reported Prognostic Understanding in Median Years [3 months]. Median, years (Inter-Quartile Range). Patient Usual Care Arm (n=71): 2.5 (1.5 to 4.0); Patient Investigational Care Arm (n=73): 2.5 (1.5 to 4.0).