Implementation of Digital Vital Sign Monitoring to Decrease Sleep Interruption and Enhance Recovery in Phase II of the PROmoting Sleep, Patient Engagement and Recovery (PROSPER) Project

This phase II/III trial examines how a sleep enhancement intervention, including the use of wearable digital vital sign monitoring device (ViSi), affects the quality of life of cancer patients receiving acute care. Sleep enchancement interventions may improve the quality of life of patients with cancer due to fewer interruptions at night during hospital stays.

Study Overview

• Status: Terminated
• Conditions: Sleep
• Intervention / Treatment: Device: ViSi Mobile device; Drug: Sleep enhancement intervention

Detailed Description

Objective:

Primary Objective:

1). Investigate the impact of our sleep enhancement intervention, that entails a wearable digital vital sign monitoring device, on variation in the quality of life of acute care cancer patients

Secondary Objectives:

1. . Assess the impact of our sleep enhancement intervention on acute care utilization e.g. length of stay, 30-day readmissions
2. . Assess the implementation and feasibility of wearable digital vital signs capture in an inpatient oncologic setting using validated instruments such as system usability scale (SUS) and Weiner implementation outcomes (AIM, FIM, IAM).
3. . Assess the impact, via validated survey instruments, of our sleep enhancement intervention on patient mood, patient activation and satisfaction with inpatient stay experience.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (> 18 years of age), english speaking, able to complete consent and survey materials.
• Patients must be admitted to the hospital for at least 3 nights.
• Patient's using pharmacological sleeping aides will be included in the study as this will help us understand if the intervention will also help patients with pre-exisitng sleep disturbances.

Exclusion Criteria:

• Vulnerable populations (pregnancy, incarcerated, history of delirium, suicidal ideation, ischemic stroke with measurable neurologic deficit, cerebral palsy, seizures), primary brain tumor/metastases patients.
• Patients concurrently enrolled in contact isolation with SARS-CoV2 will be excluded.
• Lastly, hospice or hospice-bound patients will also be excluded.
• Any patient can remove themselves from the study at any point.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention group; Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device.	Device: ViSi Mobile device; Participants will wear the device on your wrist like a watch, and it will continuously (non-stop) monitor your pulse, blood pressure, temperature, breathing rate, heart rate, and pulse rate
Other: Control group; Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.	Drug: Sleep enhancement intervention; Participants will receive a medication administration will be limited to before bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaires (EuroQol Group EQ-5D)	Score Scales (0-100) 0-worst health/100 best health	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Vijaya Gottumukkala, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-0190; NCI-2022-05712 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes