TerminatedPhase 2/3

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

Stopped: Poor accrual and poor patient engagement with survey completion

United States89 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of Life Questionnaires (EuroQol Group EQ-5D)

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05456360

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-30

Results submitted2024-10-15

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