Status:
TERMINATED
Pilot RCT Feasibility Study: Cancer and T2D
Lead Sponsor:
University of Florida
Conditions:
Diabetes Mellitus, Type 2
Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The purpose of this study is to test a nurse-led intervention for adults with newly diagnosed cancer and undiagnosed/newly diagnosed Type-2 diabetes
Detailed Description
Specific Aim 1: To examine study feasibility of a nurse-led intervention for adults with newly diagnosed cancer and T2D. We define feasibility indicators as: (a) efficient study recruitment is possibl...
Eligibility Criteria
Inclusion
- a) 18 years and older
- b) Using pathology reports, a new diagnosis of a solid tumor cancer or lymphoma within the past 3 months
- c) Patients being treated with curative intent or those with a prognosis estimated to be \>2 years, as best assessed by the oncologist.
- d) First medical oncology outpatient visit at UF within the past 3 months
- e) Plans to continue cancer care at UF
- f) Speaks and reads English
- g) Can comply with study related procedures, per the treating oncologist or advanced practice provider
Exclusion
- a) Diagnosis of leukemia or pancreatic cancer as the new cancer diagnosis
- b) Being treated for T2D for \> than 3 months
- c) eGFR \<45mL/minute/1.73m2
- d) Liver insufficiency (defined as liver enzymes over 5 times the upper limit of normal or clinical sequelae of advanced cirrhosis as documented by the treating oncologist or Advanced Practice Providers.
- e) Active infection requiring systemic antibiotics
- f) Taking systemic steroids of more than 1-week duration. Must have stopped \>3 days prior to study enrollment. Note, inhaled or topical steroids are not exclusion criteria.
- g) Planning to receive cancer care at a location outside of UF
- h) Enrolled in another study with similar outcomes.
- i) Currently taking metformin or known inability to tolerate it
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04468243
Start Date
April 1 2021
End Date
December 13 2021
Last Update
March 28 2022
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610