Sleep
Conditions
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.
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.
Interventions
DEVICEViSi 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
Participants will receive a medication administration will be limited to before bedtime.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaires (EuroQol Group EQ-5D) | through study completion, an average of 1 year | Score Scales (0-100) 0-worst health/100 best health |
Countries
United States
Participant flow
Recruitment details
Between March 2023 and October 2023, we enrolled 89 patients. 52 patients were assigned to the control group, while 37 were assigned to the intervention group. The study was terminated due to insufficient staff and the inability to enroll an adequate number of patients. Consequently, we could not draw any conclusions.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Vital Signs were monitor per standard of care | 52 |
| Intervention: Passive Vital Signs Monitoring Vital Signs were monitor per PROSPER algorithm | 37 |
| Total | 89 |
Baseline characteristics
| Characteristic | Standard of Care | Intervention: Passive Vital Signs Monitoring | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 15 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 22 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 34 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 31 Participants | 78 Participants |
| Region of Enrollment United States | 52 participants | 37 participants | 89 participants |
| Sex: Female, Male Female | 30 Participants | 10 Participants | 40 Participants |
| Sex: Female, Male Male | 22 Participants | 27 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 37 |
| other Total, other adverse events | 0 / 52 | 0 / 37 |
| serious Total, serious adverse events | 0 / 52 | 0 / 37 |
Outcome results
Primary
Quality of Life Questionnaires (EuroQol Group EQ-5D)
Score Scales (0-100) 0-worst health/100 best health
Time frame: through study completion, an average of 1 year
Population: Based on the feedback from the team it was unrealistic to complete the protocol in the estimated period due to lack of patient interest and engagement, data was not collected.