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

NCT05456360 | Terminated Phase 2 Results DMC FDA Device

• 2 other identifiers: 2022-0190NCI-2022-05712
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention group

OTHER

Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device.

Device: ViSi Mobile device

Control group

OTHER

Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.

Drug: Sleep enhancement intervention

Interventions

ViSi Mobile device 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

Intervention group

Sleep enhancement intervention DRUG

Participants will receive a medication administration will be limited to before bedtime.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

Results Point of Contact

• Title: Dr. Vijaya Gottumukkala
• Organization: The University of Texas MD Anderson Cancer Center

vgottumukkala@mdanderson.org

(713) 794-1398

Study Officials

• Vijaya Gottumukkala, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: March 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-11

Locations

US (1)