None listed
Conditions
Brief summary
The purpose of this research study is to assess the safety and practicality of using wearable devices to monitor vital signs, such as heart rate, temperature and blood pressure, in patients receiving chemotherapy and/or immunotherapy for relapsed/refractory myeloma. Who is it for? you may be eligible for this study if you are an adult who has been diagnosed with relapsed/refractory myeloma. Study details Participants will wear remote monitoring devices for 30 days following the administration of chemo-immunotherapy or CAR-T cell therapy. Vital signs will be checked 4 times a day for 30 days, participants will complete some quality-of-life questionnaires at the end of the monitoring phase and follow-up data will be collected for 100 days. This study is to inform current clinical practice incorporating wearable device technology with a goal to assist patients into the earliest, and safest, timeframe for community-based care while receiving chemo-immunotherapy and cellular therapies.
Interventions
Patient will be fitted with wearable devices for continuous vital signs monitoring for 30 days following treatment for relapsed/refractory myeloma. Patients will be stratified by treatment into two groups (SOC chemo-immunotherapy/CAR-T therapy) and the device requirements are the same for both groups.
The devices used for the trial include:
- a watch with an adhesive finger monitor to be warn continuously for the 30 days, which will monitor oxygen levels, heart rate and breathing rate
- a therm
Patient will be fitted with wearable devices for continuous vital signs monitoring for 30 days following treatment for relapsed/refractory myeloma. Patients will be stratified by treatment into two groups (SOC chemo-immunotherapy/CAR-T therapy) and the device requirements are the same for both groups. The devices used for the trial include: - a watch with an adhesive finger monitor to be warn continuously for the 30 days, which will monitor oxygen levels, heart rate and breathing rate - a thermometer sensor to be stuck to the chest area which will be worn continuously for the 30 days - a portable blood pressure machine will be used intermittently, at least twice per day for 30 days To be suitable for the study, participant's will need to own a smartphone compatible with the program used for monitoring. Participants will receive education on the devices and the program and be given a study specific information booklet at the beginning of the study by the clinical trial team. The education will be provided one-on-one, with the option of a caregiver to be present, and should take around 30 minutes. The clinical trial team will monitor the participant's data via a dashboard and can escalate deterioration patterns to the study investigators. The study team can call the participants to help troubleshoot device issue when data integrity is compromised (e.g. data not transmitting to the dashboard). The participants will also be given a number to call the study team if the notice device issues or have health concerns. Missed data points will be used to monitor compliance and device malfunction for statistical purposes.
Sponsors
Cell and Tissue Therapies WA, Royal Perth Hospital, East Metropolitan Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. People 18+ years at diagnosis of relapsed/refractory myeloma, regardless of gender 2. People who have their own personal smart phone and are confident to utilize this as part of the study 3. People who have access to transport to take them to a local emergency department within 30mins from their home address
Exclusion criteria
1. People in other countries 2. Children and/or young persons <18 years 3. People living in remote/rural communities that do not have access to a hospital emergency department within 30mins of their home address. 4. ECOG 3-4 5. People, or primary caregiver, who cannot communicate in English over the telephone 4. Women who are pregnant or nursing a child cannot participate in this study
Outcome results
None listed