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

Primary Purpose

Multiple Myeloma, Lymphoma, Transplant-Related Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feedback
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Feedback

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fitness measured by 6 minute walk test after discharge
Standard 6 minute walk test will be performed

Secondary Outcome Measures

Fitness assessed by SF-36 questionnaire after discharge
Standard SF-36 questionnaire will be completed

Full Information

First Posted
July 23, 2021
Last Updated
October 5, 2022
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04985409
Brief Title
Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant
Official Title
Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Lymphoma, Transplant-Related Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Subjects who are randomized to not get feedback about their activity will not be aware that there is another group that is receiving feedback
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fitness measured by 6 minute walk test after discharge
Description
Standard 6 minute walk test will be performed
Time Frame
3-4 weeks
Secondary Outcome Measure Information:
Title
Fitness assessed by SF-36 questionnaire after discharge
Description
Standard SF-36 questionnaire will be completed
Time Frame
3-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Paquette, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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