Pilot RCT Feasibility Study: Cancer and T2D

Study Overview
=================
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.

Official Title
-----------------
A Nurse-led Intervention in Patients With Newly Diagnosed Cancer and Type 2 Diabetes: A Pilot RCT Feasibility Study

Conditions
-----------------
Diabetes Mellitus, Type 2, Cancer

Intervention / Treatment
-----------------
* Other: Nurse-led diabetes care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-led<br>Nurse-led (group A). Patients randomized to group A will be taken to an available consultation room within the clinic and provided brief diabetes education which includes understanding what it means to have diabetes, healthy eating, and physical activity. Patients will also receive instructions on how to use a glucometer and how to take Metformin. | Other: Nurse-led diabetes care<br>* Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit<br>|
| No Intervention: Usual Care<br>Usual Care (Control; group B). Patients randomized to usual care will be informed of their HbA1c value, will continue to receive usual cancer care, and will be encouraged to follow-up with their PCP for T2D management. The RA will ensure that oncology visit clinic notes and the results of the HbA1c testing are relayed to the patient's PCP office. Patients who do not have a PCP identified will be referred to an appropriate provider. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Study acceptability (scores>8 indicate adequate acceptability) will be measured via the Study Acceptability Scale questionnaire for both groups | At 3-month study visit | 
| Point of Care HbA1c Test | 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. | At baseline visit and at 3-month study visit |