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

NCT ID: NCT04985409

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2022-10-01

Brief 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.

Detailed 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.

Conditions

Multiple Myeloma; Lymphoma; Transplant-Related Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Feedback

Participants in the intervention arm will receive a Fitbit upon admission and will receive feedback from the activity tracker and the in-room TV screen as demonstrated by the Study Navigator. Study participants in this arm will be engaging with their physicians around achievement of daily step goals by viewing the in-room TV display of their daily step counts on rounds.

Group Type: EXPERIMENTAL

Feedback

Intervention Type: BEHAVIORAL

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.

Control

Subjects in the control arm will receive a Fitbit upon admission for their transplant but neither the physician, nurse, nor patient will receive any feedback from the device. They will be blinded to any data capture by their activity monitor. Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods to encourage ambulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ronald Paquette

Medical Director, Blood and Marrow Transplant Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ron Paquette, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

CSHS0523

Identifier Type: -

Identifier Source: org_study_id