Development of an Educational Patient Decision Aid (Treatments in Advanced Cancer - Decision Aid, TA-DA) to Promote Shared Decision Making for Third-line or Beyond Palliative Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
To develop an educational patient decision aid for advanced cancer patients to prepare them to have conversations with their clinicians about treatment options (Treatments in Advanced cancer - Decision Aid, TA-DA).
详细描述
Primary Objectives:
The study objective is to develop an educational patient DA (Treatments in Advanced cancer - Decision Aid, TA-DA) to assist patients, their caregivers, and clinicians to make an informed decision about third-line or beyond palliative systemic therapy for advanced cancer. To fulfill the study's objectives, we will complete 3 study parts:
Using qualitative methods, explore the decision-making needs of patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy; identify initial preferences and recommendations to inform the design of the educational patient DA in Part II.
Following a user-centered design approach, develop and measure the acceptability of an educational patient DA to promote shared decision making among patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy.
Conduct a pilot RCT to estimate the effect of the educational patient DA (TA-DA) on patient's knowledge of their treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinicians (Part I/II/III):
- •MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer
- •Patients (Part I/II/III):
- •Age 18 or over
- •Diagnosis of advanced cancer (i.e., metastatic, relapsed, and/or incurable disease as defined by the treating oncologist) who has received at least 2 lines of palliative systemic therapy*
- •Patient-rated ECOG performance status of 1-3 for Part I/II and 2-3 for Part III
- •Able to make treatment decisions based on the clinical judgement of the oncology team
- •English speaking
- •patient has started, is receiving, and/or has completed second-line palliative systemic therapy or beyond
- •Caregivers (Part I/II/III):
- •Age 18 or older
- •Currently a primary caregiver to a patient who satisfies the patient eligibility criteria listed above
- •For the study purposes, a primary caregiver is defined as:
- •someone who provides physical, emotional, decisional and/or logistical assistance to the patient regularly (e.g. daily, weekly);
- •can be a family member, friend, or other individual in a close relationship with the patient;
- •must be identified by the patient and self-identify as the primary person providing caregiving support to the patient
- •Able to provide informed consent and participate in the study
- •English speaking
排除标准
- •Any patient who meets any of the following criteria will be excluded from participation in this study:
- •(Part I/II/III): Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker as determined by the clinical team
- •(Part III only): Participants in Part I and II
研究组 & 干预措施
EUC
Patient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool.
干预措施: Communication (Other)
TA-DA
Patient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool.
干预措施: Communication (Other)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点