Telehealth as a Nursing Strategy for Monitoring Patients in an Ambulatory Oncology Phase I Clinical Trial Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The study will be feasible as measured by the Feasibility of Intervention at study completion.
研究概览
简要总结
The study aimed to evaluate the feasibility, acceptability, satisfaction and effectiveness of telehealth on early identification and mitigation of adverse events during cycle one of a Phase 1 oncology clinical trial.
详细描述
Oncology patients in Phase 1 clinical trials receive study medications administered for the first time in humans. Participants need to be monitored closely for adverse events which can be serious and have critical implications.
A single group repeated measures design was used to evaluate the effect of telehealth on patient outcomes and patient experience for up to four telehealth sessions and nursing staff perceptions of telehealth. Enrollment was limited to 21 participants, in order to limit the number of patients for a pilot study.
Telehealth sessions began within seven days after the initial treatment and occurred weekly during cycle one of the participant's Phase 1 protocol. Side effects assessed by nursing included mucositis, nausea, vomiting, constipation, diarrhea, dyspnea, cough, rash, pain and fever. Patients were also given the opportunity to address other symptoms.
Original research was required to establish validity of telehealth for managing adverse events, dose limiting toxicities of study medications, and enhancing safe clinical care with potentially meeting unmet patient needs when beginning an oncology Phase 1 clinical trial.
Data Collection tools included:
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
- 否
入选标准
- •Cancer diagnosis
- •Consented and registered to a Phase I oncology clinical trial
- •Cycle one patient
- •18 years of age or older
- •Willing to participate in weekly telehealth sessions during cycle one
- •Patient Gateway account
- •Zoom video application downloaded and installed
- •A reliable internet connection
- •A device with the following requirements
- •PC/Mac with:
- •Chrome or Firefox as an internet browser
- •Speakers or Headphones
- •iPhone/iPad/Android Device with:
- •The Partners Patient Gateway Application
- •Front facing camera
排除标准
- •Adults who are unable to consent
- •Individuals younger than 18 years old
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Telehealth visit
Patients were approached to participate in up to four nursing telehealth visits during their cycle one Phase 1 oncology clinical trial. Nursing assessed for potential adverse events and dose limiting toxicities using the Common Terminology Criteria for Adverse Events. Previous education was reinforced for participants. If the participant was administering an oral study medication at home, dosing instructions were reviewed, and diary evaluated for proper administration and documentation.
干预措施: Telehealth (Other)
结局指标
主要结局
The study will be feasible as measured by the Feasibility of Intervention at study completion.
时间窗: From enrollment to the end of cycle one which can be up to 28 days.
Measures were scored via a Linkert scale ranging from 1 to 5. The higher the score indicates feasibility. 1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree and 5 = completely agree. Feasibility was measured by patients and nurses to see if telehealth would be feasible if implemented in a Phase 1 oncology clinical trial unit.
次要结局
- The study will be acceptable as measured by the Acceptability of Intervention Measure at study completion.(From enrollment to the end of cycle one which can be up to 28 days.)
研究者
Deborah M. Melonas, R.N
Registered Nurse
Massachusetts General Hospital