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NCT04985409 Clinical Trial

Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant

Multiple Myeloma Clinical Trial

Official title:
Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04985409
Other study ID # CSHS0523
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2021
Est. completion date October 1, 2022

Study information
Verified date October 2022
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose the research is to obtain preliminary data about the change in fitness from admission to discharge in patients undergoing an Autologous Stem Cell Transplant (ASCT) , assessed by the 6 minute walk test as the primary objective and the SF-36 as the secondary objective. All subjects will wear a Fitbit monitor while admitted for the ASCT to record their daily activity.

Description:

This study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with each diagnosis) scheduled to undergo ASCT at Cedars-Sinai Medical Center. After signing the informed consent form, intake data will be collected on all subjects will include age, diagnosis, Karnofsky performance status, and comorbidity index. Subjects will complete an SF-36 questionnaire that assesses their functional and emotional status. Each subject will undergo a 6-minute walk test (6MWT) while wearing a Fitbit monitor to record the number of steps taken. After admission, subjects will be randomly assigned to either the control or intervention group. Subjects in the control arm will receive an activity monitor but the physician, nurse, and patient will not receive any feedback from the device. Patients will be blinded to any data capture from their activity monitor. Participants in the intervention arm will receive an activity monitor and they will receive feedback from the activity tracker and the in-room TV screen. Study participants in this arm will engage with their physicians and nurses around achievement of daily step goals by viewing the in-room TV display of daily step counts on rounds. After discharge, all subjects will again complete the SF-36 questionnaire and perform a 6MWT at a routine clinic visit, within 30 days of the transplant procedure. Descriptive statistics in the form of mean and standard deviation will be used to summarize patient physical activity as measured by 6MWT.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - diagnosis of multiple myeloma or lymphoma with plan to undergo autologous stem cell transplant - at least 18 years of age - English or Spanish speaking - have access to an IOS or Android device - able to provide informed consent. Exclusion Criteria: - pre-existing physical limitations which would preclude achievement of the ambulation goals - inability to wear the activity monitor - Jehovah's Witness patients enrolled in the bloodless transplant program are excluded as they require strict bed rest for long periods of time

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Feedback
The system uses Sonifi health (TV content and visualizations) and Fitabase (3rd party server to process Fitbit data and export to Sonifi). The system utilizes the patient's TVs to engage the patient and multidisciplinary team in monitoring ambulation status.

Locations
Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fitness measured by 6 minute walk test after discharge Standard 6 minute walk test will be performed 3-4 weeks
Secondary Fitness assessed by SF-36 questionnaire after discharge Standard SF-36 questionnaire will be completed 3-4 weeks
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