Digital Remote Patient Monitoring and Triage During Cancer Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility via engagement with surveys
研究概览
简要总结
The goal of this study is to evaluate the feasibility of using information from wearable devices and self-reported symptoms to remotely monitor patients during immunotherapy. The main questions it aims to answer are:
- Is the digital remote patient monitoring tool feasible and acceptable to patients?
- Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?
Participants will:
- Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.
- As feasible: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).
If participant is randomly assigned to the intervention group, they will also:
- Complete weekly symptom ratings via digital remote patient monitoring tool
- Wear a Fitbit activity tracker as feasible for 90 days.
- At the end of the study, complete a semi-structured interview to provide feedback on the study.
详细描述
Participants (n = 40) will be recruited from UPMC Hillman clinics.
If eligible patients consent to participate, they will complete online baseline, midpoint, and end of study questionnaires. Participant's medical records will be reviewed to extract demographic information and clinical covariates, including information about their cancer, its treatment, biological variables such as sex and age, clinical variables such as comorbidities, surgeries and hospitalizations, medications, and other markers of health care utilization (e.g., emergency department visits). Once extracted, these values will be linked only to their study ID number.
As feasible, participants will complete the Short Physical Performance Battery (SPPB) at the UPMC Hillman Cancer Center or the research team's office at baseline and at the end of the study. During these visits, this in-person assessment will be administered by trained study team members. Participants that enroll in the study remotely will be invited to complete the in-person SPPB as feasible. The SPPB will be conducted within one month of the enrollment date and within one month of the end of study date.
Following informed consent and completing baseline questionnaires, participants will then be randomized into the digital remote monitoring group or usual care (1:1).
For participants in the intervention condition (digital remote monitoring group):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •receiving immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for melanoma;
- •age 18 years or older;
- •ability to read and write in English;
- •owns and uses a smartphone capable of running study applications
排除标准
- •under 18 years old; and
- •unable to read and write in English
研究组 & 干预措施
Digital remote monitoring group (intervention)
Participants will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB) as feasible. Participants will rate symptoms weekly for 90 days using PRO-CTCAE questions to assess symptoms commonly associated with immune-related adverse events (irAEs). Participants will also wear a Fitbit activity tracker (Inspire 3 or similar) as feasible for the duration of the study and install the Fitbit app on their smartphone. The Fitbit is a wristwatch-sized waterproof device that assesses heart and breathing rates, physical activity, and sleep, skin temperature, and oxygen levels and wirelessly transmits data to the server. Data from the wearable devices along with electronic patient-reported outcomes will be used to detect and triage immune-related adverse events.
干预措施: Digital remote monitoring intervention (Behavioral)
Usual care
This group will complete baseline, midpoint, and end of study measures and complete the Short Physical Performance Battery (SPPB) as feasible but will not wear an activity tracker or rate weekly symptoms.
干预措施: Usual Care (Other)
结局指标
主要结局
Feasibility via engagement with surveys
时间窗: From enrollment to the end of the intervention (at approximately 90 days)
engagement (how many weeks participants completed symptom surveys)
Feasibility via completion rate
时间窗: From enrollment to the end of the intervention (at approximately 90 days)
completion rate (number of participants that complete the study)
Acceptability via semi-structured interviews
时间窗: At the end of the intervention (at approximately 90 days)
Post-intervention semi-structured interviews will be conducted to gather participant feedback and assess acceptability of the intervention. Participants will be asked to rate the likelihood they would keep using system on their own and to recommend system on a scale from 0 (not at all likely) to 10 (extremely likely). Responses will be averaged.
Acceptability via System Usability Scale
时间窗: At the end of the intervention (at approximately 90 days)
System Usability Scale (SUS). For odd items, subtract one from the user response. For even-numbered items, subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. Possible range of scores is 0 to 100 representing a composite measure of the overall usability of the system being studied.
Feasibility via accrual rate
时间窗: From enrollment to the end of the intervention (at approximately 90 days)
accrual rate (number of participants that enroll \[consent and provide at least one form of data\] out of number of participants approached)
Feasibility via engagement with Fitbit
时间窗: From enrollment to the end of the intervention (at approximately 90 days)
engagement (how many days within the study the participants had Fitbit data)
次要结局
- Patient-Reported Physical Symptoms(Change from baseline to the end of the intervention (at approximately 90 days))
研究者
Carissa Low
Associate Professor
University of Pittsburgh