N/A
N=186
Improving Informed Consent for Palliative Chemotherapy
Metastatic Colorectal Cancer · Metastatic Pancreatic Cancer · Unresectable Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02282722 ↗Enrolled (actual)
186
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Number of Patients With Accurate Understanding of Chemotherapy Benefits — 39; 39; 30; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational informed consent for chemotherapy (Other); Usual, standard-of-care informed consent for chemotherapy (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Accurate Understanding of Chemotherapy Benefits |
39; 39; 30; 31; 2; 3 | — |
| SECONDARY Number of Patients With Accurate Understanding of Chemotherapy Risks |
47; 33; 31; 41; 1; 1 | — |
| SECONDARY Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy |
10; 9; 68; 65; 1; 1 | — |
| SECONDARY Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores |
5.2; 5.5 | — |
| SECONDARY Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process |
48; 39; 30; 35; 1; 1 | — |
| SECONDARY Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores |
3.6; 3.7 | — |
| SECONDARY Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team |
60; 55; 10; 16; 1; 2 | — |
| SECONDARY Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale |
79.6; 84.7 | — |
| SECONDARY Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment |
16.5; 17.3 | — |
| SECONDARY Patient-Reported Prognostic Understanding in Median Years |
2.5; 2.5 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02282722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.