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NCT04258813 · ClinicalTrials.gov registry record · NA
Onco-primary Care Networking to Support TEAM-based Care
A NA study of Cancer and Hypertension, sponsored by Duke University.
- Active
- Registry status
- NA
- Development phase
- 313
- Enrollment target
- 1
- Study location
NCT04258813 is a NA study of Cancer and Hypertension that is active but no longer recruiting, run by Duke University. The registered enrollment target is 313 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04258813, a NA study of Cancer and Hypertension, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 313 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.
Conditions Studied
Interventions
- BEHAVIORAL Control
- BEHAVIORAL iGuide Intervention (Self-guided)
- BEHAVIORAL iGuide 2 Intervention (Tailored/Targeted)
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04258813
The ClinicalTrials.gov registry entry for NCT04258813 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which Control is the first listed.
NCT04258813 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04258813 about?
NCT04258813 is a clinical study titled "Onco-primary Care Networking to Support TEAM-based Care". The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to random...
What is the current status of trial NCT04258813?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 313 participants. The study started on 2021-06-14. Estimated completion is 2026-07-31.
What conditions does trial NCT04258813 study?
This clinical trial studies the following conditions: Cancer, Hypertension, Non-Small Cell Lung Cancer, Blood Pressure, Cancer, Breast.
What interventions are being tested in trial NCT04258813?
The interventions under investigation include: Control (BEHAVIORAL), iGuide Intervention (Self-guided) (BEHAVIORAL), iGuide 2 Intervention (Tailored/Targeted) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04258813?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04258813 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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