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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 16
- 主要终点
- Number of Patients With Accurate Understanding of Chemotherapy Benefits
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •English proficiency (reading and speaking)
排除标准
- •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.
结局指标
主要结局
Number of Patients With Accurate Understanding of Chemotherapy Benefits
时间窗: 3 months
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.
次要结局
- Number of Patients With Accurate Understanding of Chemotherapy Risks(2 weeks)
- Patient-Reported Prognostic Understanding in Median Years(3 months)
- Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy(2 weeks)
- Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores(2 weeks)
- Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores(2 weeks)
- Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment(3 months)
- Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team(3 months)
- Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process(2 weeks)
- Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale(3 months)
研究者
Andrea Enzinger
Chief, Division of Population Sciences
Dana-Farber Cancer Institute