PATHOS Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Socio-economic and demographic characteristics
研究概览
简要总结
This study is aiming to look into patients' treatment preferences and their socio economic background as well as the exploration of thought processes leading to these preferences. It will integrate, in two exploratory questionnaires, the three most common treatment schema (standard of care, non-operative management, surgery alone) all of which have been demonstrated efficacious.
详细描述
The primary study objective is to evaluate socioeconomic and demographic factors involved in patients' / physicians treatment preferences. The secondary objective is to assess the tradeoff level between the benefits versus quality of life.
This study will evaluate 192 participants: 14 physicians (group A) and 178 patients (group B).
Participants with operable rectal cancer or health professionals will be screened for eligibility. Subsequently, these participants will be offered to participate in this pilot study and provided a consent form. When a participant has consented to participate, he/she will be provided with a first questionnaire (socio-demographic characteristics, some clinical data and medical baseline information as well as details about their current knowledge about treatments).
An informational brochure will be given after answering the first questionnaire describing different treatment regimens, treatment duration, potential side effects and oncologic outcomes.
A second questionnaire will be provided (evaluating patients treatment preferences and tradeoff).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •New rectal cancer patient
- •Operable patients
- •Capable adults older than 18 years of age
- •Capacity to sign a consent form
- •Capacity to answer questionnaires on an online platform Group B
- •Treating physician specialists
- •Capacity to sign a consent form
- •Capacity to answer questionnaires on an online platform
排除标准
- •Patient unable to sign a consent form
- •Patients with metastasis
- •Recurrent tumours
- •Inability to answer questionnaires on an online platform
- •Inability to communicate in french or english
- •Participant unable to sign a consent form
- •Inability to answer questionnaires on an online platform
结局指标
主要结局
Socio-economic and demographic characteristics
时间窗: 1 day
The primary study objective is to evaluate socioeconomic and demographic factors involved in patients' / physicians treatment preferences. This will be evaluated with the first questionnaire given at the time of the first consultation or when first approached by a research team member.
次要结局
- Tradeoff level(1 day)
研究者
Dr. Te Vuong
Radiation-oncologist
Sir Mortimer B. Davis - Jewish General Hospital