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临床试验/NCT07218874
NCT07218874已完成不适用

Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2026年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Feasibility via completion rate

研究概览

简要总结

The goal of this study is to determine whether a mobile application that combines real-time sensor data and patient-reported symptoms to trigger care-team contact recommendations is feasible and beneficial for patients receiving chemotherapy. The main questions it aims to answer are:

  • Is the mobile application 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.
  • Complete daily symptom ratings.
  • Wear a Fitbit activity tracker for 90 days.
  • At the end of the study, complete a semi-structured interview to provide feedback on the study.
  • Optional: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).

详细描述

Participants (n=50) 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.

Following informed consent, participants will have the ROSA Android or iOS application installed on their smartphones that are capable of running the app (or will be talked through the installation of the app on their smartphone if conducting visit remotely). The application will securely store this information on the device and transmit this information to a secure cloud-based research server over secure network (WiFi or cellular) connection at least once per day. All data will be de-identified and will use only a study ID number linked to identifying participant information in a password protected file. The data captured for the research will not include any personally identifiable information. The data plan requirements of the application are not significantly different from what most smartphone users would require if they use their device to access the Internet for web searching.

At the initial visit (either in person or online, 20-30 minutes), participants will also be oriented to the ecological momentary assessment procedures to assess patient-reported symptoms. Participants will install the ROSA Android or iOS application on their smartphones. The unique non-identifying participant ID will be entered into the app upon initial log in and will be saved locally on the device. This code number will be attached to participant data so that the research team will be able to know which participant code number each survey response is associated with. Participants will be able to set the time of day for which they wish to receive notifications to complete the daily symptom ratings. When participants receive the survey notification, it will open up the study application and they can proceed to take the daily survey (approximately 5 minutes) via an anonymous Qualtrics survey link embedded in the app and opened in their smartphone's internet browser. Symptoms will be assessed using the PRO version of the Common Terminology for Adverse Events (PRO-CTCAE).

Participants will be asked to complete at least one rating per day and will report on symptoms over the last 24 hours. Responses range from 0-4; any grade 1 response (reflecting mild symptoms) will trigger a recommendation to view symptom management/education tips available in a self-care library in the app, and any grade 2-4 response (reflecting moderate to severe symptoms) will trigger a recommendation that the participant may want to contact their provider about the potentially concerning symptom. Reports will be automatically generated and emailed each week displaying their summarized data and a list of all the individual data points that triggered alerts which they can then share with their care team, family members, etc. Weekly reports will include a link to an optional survey asking for feedback on how they've used the last week's report. In addition to the PRO-CTCAE questions in the daily survey, participants will also be asked to rate their overall quality of life for that day from 0 (worst possible) to 10 (best possible), about any cancer treatment they've received since the last survey, about any communication with their cancer care team since their last survey, and approximately how much time they spent each day on tasks related to cancer care.

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

  • •Receiving chemotherapy at the UPMC Hillman Cancer Center for any solid tumor cancer at any stage with at least two cycles remaining;
  • •age 18 years or older;
  • •ability to read and write in English;
  • •sufficient performance status to participate in research (e.g., Karnofsky performance status of 60-100%); and
  • •owns and uses an Android smartphone or an iPhone capable of running the study apps.

排除标准

  • •under 18 years old; and
  • •unable to read and write in English

研究组 & 干预措施

Symptom monitoring via smartphone app

Experimental

Participants will rate symptoms daily for 90 days using PRO-CATCAE questions to assess 8 common chemotherapy-related symptoms. Participants will wear a Fitbit (Inspire 3 or similar) 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.

干预措施: Mobile Symptom Monitoring and Alert App (Behavioral)

结局指标

主要结局

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)

Feasibility via engagement

时间窗: From enrollment to the end of the intervention (at approximately 90 days)

engagement (how many days within the study the participants engaged with the app and had Fitbit data)

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 program (e.g., likelihood to keep using app and to recommend app)

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)

次要结局

  • Patient-Reported Physical Symptoms(Change from baseline to the end of the intervention (at approximately 90 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carissa Low

Associate Professor

University of Pittsburgh

研究点 (1)

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