Mobile Health Device Study for Myeloma Patients

Completed

• Conditions: Multiple Myeloma; Myeloma
• Interventions: Device: Garmin Vivofit device; Behavioral: Mobile Health quality of life assessements

• Registration Number: NCT03006315
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Enrolled participants health status will be tracked by using a mobile health-monitoring device while undergoing chemotherapy for multiple myeloma.

Detailed Description

Newly diagnosed multiple myeloma participants receiving induction chemotherapy will be continuously bio-monitored at baseline (1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles using the Garmin Vivofit wearable device. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT. The study will include a total of 40 newly diagnosed multiple myeloma participants in two cohorts with 20 patients in each cohort (Cohort A and B). Cohort A will be comprised of patients \<65 years. Cohort B will be comprised of patients \>/= 65 years.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-30
• Status Verified: 2024-11
• Primary Completion: 2024-11-14
• Study Completion: 2024-11-14
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B: >/= 65 years	Garmin Vivofit device	Cohort B will be comprised of participants \>/= 65 years and will accrue a total of 20 patients.
Cohort A: <65 years	Garmin Vivofit device	Cohort A will be comprised of participants \<65 years old and will accrue a total of 20 patients.
Cohort B: >/= 65 years	Mobile Health quality of life assessements	Cohort B will be comprised of participants \>/= 65 years and will accrue a total of 20 patients.
Cohort A: <65 years	Mobile Health quality of life assessements	Cohort A will be comprised of participants \<65 years old and will accrue a total of 20 patients.

Primary Outcome Measures

Name	Time	Method
Number of patients continuously wearing the device.	1 year	Feasibility of using mobile wearable health device

Trial Locations

Locations (5)

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States