ISRCTN25569053
Active, not recruiting
Phase 4
Evaluating the use of a smartphone application and biosensor by cancer patients undergoing systemic treatments
Roche (United States)0 sites100 target enrollmentJanuary 7, 2022
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cancer (Solid Tumour)
- Sponsor
- Roche (United States)
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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