Clinical trial NCT04468243: Pilot RCT Feasibility Study: Cancer and T2D
Official title: A Nurse-led Intervention in Patients With Newly Diagnosed Cancer and Type 2 Diabetes: A Pilot RCT Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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 possible given prevalence of T2D (diagnosed and undiagnosed) in UF patients with newly diagnosed cancer; (b) retention rates in both groups ≥80% to indicate that the study design and methods are adequately patient-centered; (c) identified barriers to and facilitators of a nurse-led intervention are respectively modifiable or optimizable; and (d) patient acceptability scores \>8 for the study procedures. We hypothesize that we will recruit up to 40 patients within 18 months and retain ≥ 80% of patients in all groups; minor but important revisions will be required to resolve issues identified with using the nurse-led intervention; and 80% of patients from both groups who complete the study will report that the burden of the study is acceptable through their retention in the study.

Specific Aim 2: To determine the variation in HbA1c at baseline and at the end of the three-month intervention period in each of the two study groups.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Acceptability
timeFrame: At 3-month study visit
measure: Point of Care HbA1c Test
timeFrame: At baseline visit and at 3-month study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Lisa Scarton
role: PRINCIPAL_INVESTIGATOR
References: