Back to resultsPilot RCT Feasibility Study: Cancer and T2D
Primary Purpose
Diabetes Mellitus, Type 2, Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse-led diabetes care
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nurse-led
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Acceptability
Study acceptability (scores>8 indicate adequate acceptability) will be measured via the Study Acceptability Scale questionnaire for both groups
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04468243
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse-led
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nurse-led diabetes care
Intervention Description
Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit
Primary Outcome Measure Information:
Title
Acceptability
Description
Study acceptability (scores>8 indicate adequate acceptability) will be measured via the Study Acceptability Scale questionnaire for both groups
Time Frame
At 3-month study visit
Title
Point of Care HbA1c Test
Description
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.
Time Frame
At baseline visit and at 3-month study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Scarton
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot RCT Feasibility Study: Cancer and T2D
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