Design of a Medical Device for Oxaliplatin-Induced Peripheral Neuropathy Considering the Patient's Voice in Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Co-design a medical device with patients to develop a solution that can prevent the onset of oxaliplatin-induced peripheral neuropathy (OIPN)
研究概览
简要总结
This is an observational study related to a medical device designed for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with gastrointestinal cancer. The primary objective is to collect data through interviews with patients experiencing OIPN symptoms to co-design the medical device prototype, incorporating the patient's perspective. Additionally, the study aims to identify clinical and usability patterns that will help optimize the design of a future clinical investigation assessing the safety and efficacy of the final device.
详细描述
Main Hypothesis:
The clinical data collected from patient interviews, along with their active participation in the co-design of the localized cooling medical device, likely in the form of gloves, will enable the design of both the functional prototype and the future clinical research on safety and efficacy. This approach will increase the likelihood of patient acceptance of the medical device treatment and help identify different patient profiles that could benefit the most from it.
Secondary Hypotheses:
- Patients will be able to easily adhere to the use of the device during chemotherapy.
- The final glove design, in terms of materials and structure, will be suitable for commercial manufacturing and will have a viable demand among patients and healthcare providers.
- There is no difference in treatment adherence between men and women or among people of different ages.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Outpatient patient with gastrointestinal cancer treated with oxaliplatin.
- •Having completed at least three cycles of chemotherapy.
- •Presenting acute or chronic symptoms of chemotherapy-induced peripheral neuropathy.
- •The study will include individuals over 18 years old. Gender identify will be collected confidentially and inclusively, offering options for non-binary individuals and those who prefer not to identify with binary categories.
排除标准
- •Patient with osteoarthritis or arthritis in the hands.
- •Diagnosis of any autoimmune disease affecting connective tissue, such as: rheumatoid arthritis, Raynaud's syndrome, lupus, scleroderma, dermatomyositis, vasculitis, or cryoglobulinemia.
研究组 & 干预措施
Observational group of patients with gastrointestinal cancer treated with oxaliplatin.
干预措施: Clinical interviews with patients and Usability interviews and glove testing. (Other)
结局指标
主要结局
Co-design a medical device with patients to develop a solution that can prevent the onset of oxaliplatin-induced peripheral neuropathy (OIPN)
时间窗: From baseline to 6 months
Interviews will be conducted with patients to gather information on the clinical presentation of oxaliplatin-induced peripheral neuropathy and its impact on patients' quality of life.
次要结局
- Gain an in-depth understanding of the progression of OIPN symptoms.(From baseline to 6 months)
- Ensure the usability of the device by assessing the patient's ability to adhere to treatment with a medical device.(From baseline to 6 months)
- Determine the design characteristics of the gloves.(From baseline to 6 months)
研究者
Sandra Soriano-Sánchez
Principal Investigator
Corporacion Parc Tauli