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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05712 | Other Identifier | NCI-CTRP Clinical Trials Reporting Registry |
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Poor accrual and poor patient engagement with survey completion
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Other | Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device. |
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| Control group | Other | Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vijaya Gottumukkala, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Vital Signs were monitor per standard of care |
| FG001 | Intervention: Passive Vital Signs Monitoring | Vital Signs were monitor per PROSPER algorithm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2023 |
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| Sleep enhancement intervention | Drug | Participants will receive a medication administration will be limited to before bedtime. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Vital Signs were monitor per standard of care |
| BG001 | Intervention: Passive Vital Signs Monitoring | Vital Signs were monitor per PROSPER algorithm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life Questionnaires (EuroQol Group EQ-5D) | Score Scales (0-100) 0-worst health/100 best health | 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. | Posted | through study completion, an average of 1 year |
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Events were monitored during patients' admission. Admission Time average was 3.5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Vital Signs were monitor per standard of care | 0 | 52 | 0 | 52 | 0 | 52 |
| EG001 | Intervention: Passive Vital Signs Monitoring | Vital Signs were monitor per PROSPER algorithm | 0 | 37 | 0 | 37 | 0 | 37 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vijaya Gottumukkala | The University of Texas MD Anderson Cancer Center | (713) 794-1398 | vgottumukkala@mdanderson.org |
| Oct 15, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2022 | Nov 22, 2024 | ICF_001.pdf |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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