Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- AMMA Feasibility Within PH&S System
研究概览
简要总结
The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the PH&S system.
详细描述
A novel cold capping device, named Amma™, is now commercially available for use and FDA approved. The Amma system has the potential to be as effective as the Penguin Cold Cap system, but with key innovations that make it more efficient and feasible in the clinic. Innovations include:
- Portable and battery powered unit, not requiring dry ice
- Form-fitting scalp cap that eliminates the need for frequent cap exchanges The Amma system has not been evaluated for efficacy, and no clinical trials are published.
Because of the ease of use and the self-directed administration of the Amma scalp cooling device, we wish to explore this as an option for patients treated within the PH&S system. To do this, we propose an observational study that evaluates clinical outcomes and patient-reported satisfaction amongst a cohort of patients who undergo self-directed scalp cooling using the Amma system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Women with stage I-III breast cancer are eligible to participate if:
- •They consent to conduct baseline (week 0) and follow-up (week 4 post-chemo) surveys/interviews
- •They consent to be photographed at baseline (week 0) and follow-up (week 4 post-chemo), to document hair retention outcomes
- •Curative-intent chemotherapy is planned with a taxane-based, anthracycline-sparing chemotherapy regimen (which includes but may not be limited to: TC x 4, T x 12, TCHP x6)
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Anywhere from 14 to 0 days prior to treatment, enrolled subjects will complete the following questionnaires, and their hair will be photographed by research staff.
Once enrolled, subjects will be provided the Amma device by the clinic on days of chemotherapy treatment, and upon completion of treatment it will be returned to the clinic for safekeeping. Upon completion of chemotherapy, anywhere from 3-6 weeks following treatment, subjects will repeat the questionnaires and their hair will be photographed again.
Subjects will then complete their enrollment in the study.
干预措施: Amma Cooling Caps (Device)
结局指标
主要结局
AMMA Feasibility Within PH&S System
时间窗: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients with early-stage breast cancer within oncology suites within the PH\&S system. Patient satisfaction will be assessed using pre and post treatment questionnaires related to the Amma system and an exit interview.
次要结局
- Patient Satisfaction Utilizing the Was It Worth It Questionnaire(End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen))
- Patient Reported Outcome Utilizing Dean's Score(End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen))
- Patient Reported Outcome Utilizing Body Image Scale(End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen))