Cancer (Solid Tumour) Cancer
Conditions
Interventions
Vanguard Phase Cohort: Participants will be asked to wear the Sensor and use the APP for 2 weeks. At the end of the observation period, participants will be asked to complete the modified versions of
Sponsors
Roche (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be between 18-80 years of age 2. Have a biopsy-proven current diagnosis of cancer. Cancer may be metastatic or non-metastatic, but the cancer type must be a solid tumour. Participants with current blood cancers are not eligible but those who have a history of a blood cancer, have completed therapy at least 12 months prior to enrolment, and are considered NED (no evidence of disease) are eligible 3. Scheduled to receive, or within 4 weeks following first dose of intravenous (IV) or oral cancer systemic therapy as an initial or a new line of treatment for their current disease 4. Able to wear the selected Sensor daily and as advised by the manufacturer’s device instruction manual 5. Able to provide informed consent, understand and provide information for study forms and in APP ePRO survey and questionnaires in English 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at enrolment
Exclusion criteria
Exclusion criteria: 1. Plan to receive radiation or hormone therapy only 2. Diagnosed with non-melanoma skin cancer or haematological malignancies only 3. Wearing pacemakers, implantable cardioverter defibrillators, cochlear implants, and/or neurostimulator devices 4. Living in a nursing home or skilled nurse facility at the time of enrolment 5. Participating in a clinical trial 6. Citizen of the European Union 7. Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of the study recruitment protocol measured by the number of participants screened each month during enrolment in Vanguard and Operational phase 2. Feasibility of the study recruitment protocol measured by the percentage of screened participants who are eligible each month during enrolment in Vanguard and Operational phase 3. Feasibility of the study recruitment protocol measured by the percentage of eligible participants who consent each month during enrolment in Vanguard and Operational phase 4. Feasibility of the onboarding protocol as measured by the percentage of consenting participants with a successfully activated app and sensor in Vanguard phase of 2 weeks and Operational phase of 6 weeks 5. Feasibility of the onboarding protocol as measured by the percentage of consenting participants who successfully complete the APP electronic participant-reported outcomes (ePRO) survey and record and store or transmit sensor data within 24-hours of onboarding in Vanguard phase of 2 weeks and Operational phase of 6 weeks 6. Completeness of data capture as measured by the percentage of completed ePRO APP surveys successfully transmitted, stored, and retrieved from the secure cloud environment during the observation period or prior to discontinuation in Vanguard phase of 2 weeks and Operational phase of 6 weeks 7. Completeness of data capture as measured by the percentage of the sensor data collected from the participants successfully recorded or transmitted, stored, and retrieved from the secure cloud environment during the observation period or prior to discontinuation in Vanguard phase of 2 weeks and Operational phase of 6 weeks 8. Completeness of data capture as measured by the number of days sensor data was successfully collected during the observation period in Vanguard phase of 2 weeks and Operational phase of 6 weeks 9. Partic | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant persistence with ePRO APP survey completion measured from the first day the participant completes the ePRO APP survey to the first 2 consecutive days of an incomplete or missing ePRO APP survey within the Vanguard phase of 2 weeks and Operational phase of 6 weeks 2. Participant persistence with wearing and synchronizing sensor measured from the first day the sensor data is recorded on the sensor or transmitted to and stored in the secure cloud environment to the first 2 consecutive days without any sensor data recorded on the sensor or transmitted to the secure cloud environment within the Vanguard phase of 2 weeks and Operational phase of 6 weeks | — |
Countries
United States of America
Contacts
Public ContactElaine Yu
Outcome results
None listed