A study to evaluate the use of a smartphone application and biosensor by cancer participants undergoing systemic treatments

Phase 4

• Conditions: Cancer; Cancer (Solid Tumour)

• Registration Number: ISRCTN25569053
• Lead Sponsor: Roche (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-07
• Last Update Posted: 17 January 2022
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified