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A study to evaluate the use of a smartphone application and biosensor by cancer participants undergoing systemic treatments.
Evaluating the Use of a Smartphone Application and Biosensor by Cancer Patients Undergoing Systemic Treatments
- Cancer
- Solid Tumors
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Not yet recruiting
This trial runs in
Country
- United States
Trial Identifier:
ML41539
Trial Summary
Cancer is a disease in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. Cancer can be of different types, with one of them being solid tumours. Solid cancers are defined as abnormal cellular growths in "solid" organs such as the breast or prostate and does not contain cysts or liquid areas. The treatment for such tumours involves surgery, chemotherapy, chemoradiation, etc. While on treatment, participants may require emergency visits to the hospital due to treatment-related symptoms such as pain, nausea (the uneasiness of the stomach that often comes before vomiting), and dehydration. These symptoms may be preventable with earlier symptom management by monitoring them. The study aims to resolve this by helping doctors and the participant care team with real-time data so that they may help participants before their symptoms reach critical levels to reduce emergency department visits and inpatient hospital stays. The main purpose of this study is:
- To evaluate the feasibility and usability of the patient-facing smartphone application (APP) and Sensor technology
- To determine how well the APP captures, stores, transmits, and retrieves from the cloud the participant data that has been collected
- To assess the overall participant satisfaction with the Sensor and APP
- To assess the participants’ compliance to use the Sensor and the APP
- To validate self-reported emergency department (ED) visits and in-patient (IP) hospital visits
- To evaluate the feasibility of Electronic Case Report Form (eCRF) data collection and submission
F. Hoffmann-La Roche (USA)
Sponsor
ML41539
Trial Identifier
Both
Gender
18-80 Years
Age
No
Healthy Volunteers
Who can participate?
People aged between 18 to 80 years with a confirmed diagnosis of solid tumours.
What does the study involve?
Participants may be asked to be in the study for a maximum of 12 months. This includes:
- Initial Survey: The participant will be asked to fill up a 10-min basic survey regarding demographics (education, marital status, income, etc.), health information and technology ownership and technology use for health purposes
- Observation Phase: Participants will be provided with a pre-paired Samsung Galaxy Watch3 and a Samsung Galaxy A12 smartphone with the pre-installed Project Zebra app. The participant will be asked to wear a Samsung Galaxy Watch3 biosensor device, which will automatically measure the vital signs (heart rate, oxygen level in blood, activity, sleep and falls), and to complete daily surveys regarding the symptoms and any unplanned visits to the hospital or emergency department, daily, for a 2-week or 6-week period
- Interview or Focus Group: After completion of the Observation Phase, some participants may be asked to participate in an interview or focus group via phone or video conferencing. If selected, they will be asked questions about the experience with the sensor and the app
- At the end of the study period, participants will be asked to return the Samsung Galaxy Watch3 biosensor and Samsung Galaxy A12 smartphone to the care team and complete a qualitative survey
Participants will be recruited in one of the following Phase:
- Vanguard Phase: The participants will be asked to wear the Sensor and use the APP 24-hours, daily for a period of 2 weeks
- Operational Phase: If the Vanguard Phase is completed, the participants will be recruited in this phase and will be asked to wear the Sensor and use the APP 24-hours, daily for up to 6 weeks.
What are the possible benefits and risks of participating?
Participants will not receive any direct medical benefit from participating in this study, but the information will help researchers and doctors to learn more about improving side effect management and reducing unnecessary trips to the emergency department and hospital. Also, they will receive a total of $115 in two-parts for their participation in the study.
There are no major risks from participating in the study, but participants may experience the following:
- Wearing the Samsung Galaxy Watch3 may cause skin irritation and discomfort
- A small risk of becoming distressed from reflecting on the symptom and emergency department and hospital visits while completing the in-app questionnaire and study surveys
- Although the sponsor takes great care to protect participant’s information, there is a slight risk of loss of confidentiality.
- There are potential safety risks associated with the use of the Samsung Galaxy Watch3 which include inhalation or swallowing of small parts can be dangerous or even fatal, burns and explosions if batteries are exposed to fire, etc.
- There are potential safety risks associated with the use of the Samsung Galaxy A12 smartphone which include electric shocks, if the device is wet or used with wet hands while charging, prolonged use might increase the device temperature
Where is the study run from?
Genentech (USA)
When is the study starting and how long is it expected to run for?
December 2020 to October 2023
Who is funding the study?
F. Hoffmann-La Roche (USA)
Who is the main contact?
Dr Elaine Yu, global-roche-genentech-trials@gene.com
Trial Summary
Cancer is a disease in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. Cancer can be of different types, with one of them being solid tumours. Solid cancers are defined as abnormal cellular growths in "solid" organs such as the breast or prostate and does not contain cysts or liquid areas. The treatment for such tumours involves surgery, chemotherapy, chemoradiation, etc. While on treatment, participants may require emergency visits to the hospital due to treatment-related symptoms such as pain, nausea (the uneasiness of the stomach that often comes before vomiting), and dehydration. These symptoms may be preventable with earlier symptom management by monitoring them. The study aims to resolve this by helping doctors and the participant care team with real-time data so that they may help participants before their symptoms reach critical levels to reduce emergency department visits and inpatient hospital stays. The main purpose of this study is:
- To evaluate the feasibility and usability of the patient-facing smartphone application (APP) and Sensor technology
- To determine how well the APP captures, stores, transmits, and retrieves from the cloud the participant data that has been collected
- To assess the overall participant satisfaction with the Sensor and APP
- To assess the participants’ compliance to use the Sensor and the APP
- To validate self-reported emergency department (ED) visits and in-patient (IP) hospital visits
- To evaluate the feasibility of Electronic Case Report Form (eCRF) data collection and submission
F. Hoffmann-La Roche (USA)
Sponsor
ML41539
Trial Identifier
Cancer (Solid Tumour)
Condition
Official Title
Evaluating the Use of a Smartphone Application and Biosensor by Cancer Patients Undergoing Systemic Treatments
Eligibility Criteria
Both
Gender
18-80 Years
Age
No
Healthy Volunteers
For the latest version of this information please go to www.forpatients.roche.com