Designing a Decision Aid to Help People With Medullary Thyroid Cancer Make Decisions With Their Doctors About Whether to Start or Stop New Drugs, Enroll in Clinical Trials, or Continue With Active Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Decision aid acceptability
研究概览
简要总结
This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.
详细描述
PRIMARY OBJECTIVES:
I. To assess patient/survivor, caregiver/family member, and provider decision-making needs.
II. To design and develop an initial patient decision aid prototype. III. To pilot test its acceptability. IV. To evaluate the acceptability and usability of the decision aid prototype from patients/survivors, caregivers and providers in a real world environment.
OUTLINE:
Participants use decision aid and complete questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Aged 18 years old or older
- •Have or will face(d) this decision, including: Patient/survivor - who has medullary thyroid carcinoma, as determined by a clinician or documented in the Genetics of Endocrine Neoplasia Registry or sporadic (medullary thyroid carcinoma) MTC database; Caregiver/family member - of patient/survivor who has medullary thyroid carcinoma, as nominated by the patient/survivor; and Provider - who treats patients/survivors who have medullary thyroid carcinoma, as described above
- •Able to speak, read, and write English
- •Pregnant patients are included
排除标准
- •-Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)
研究组 & 干预措施
Supportive care (decision aid)
Participants use decision aid and complete questionnaires.
干预措施: Decision Aid (Other)
Supportive care (decision aid)
Participants use decision aid and complete questionnaires.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Decision aid acceptability
时间窗: Up to 1 year post decision aid
The research team will review the Think Aloud interview notes for potential opportunities for improvement. Responses to the post-decision aid acceptability questionnaire will be tabulated and summarized into tables for publication and presentation using Excel. The Stakeholder Advisory Panel will review responses to the post-decision aid acceptability questionnaire, to confirm that viewing the decision aid provides a balanced presentation of the options and is not likely to bias patients'/survivors' initial preferences.
Needs assessment
时间窗: Up to 1 year
The research team will tabulate and summarize responses to the needs assessment questionnaire to identify priority design needs, and review open text areas for notable suggestions.
Real World Evaluation
时间窗: Up to 1 year post
Responses to the participant characteristics will be tabulated and summarized for presentation and publication, as appropriate. The research team will tabulate and summarize responses to the needs assessment questionnaire to identify priority design needs and review open text areas for notable suggestions.
Decision aid design refining (storyboarding)
时间窗: Up to 1 year
During storyboarding, the research team will iteratively review the interviewers' notes regarding participant feedback, identify predominant recommendations for improvement, and make decisions to refine the decision aid design.
次要结局
未报告次要终点