- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04468243
Pilot RCT Feasibility Study: Cancer and T2D
A Nurse-led Intervention in Patients With Newly Diagnosed Cancer and Type 2 Diabetes: A Pilot RCT Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nurse-led
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.
|
Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit
|
No Intervention: Usual Care
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
Time Frame: At 3-month study visit
|
Study acceptability (scores>8 indicate adequate acceptability) will be measured via the Study Acceptability Scale questionnaire for both groups
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At 3-month study visit
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Point of Care HbA1c Test
Time Frame: At baseline visit and at 3-month study visit
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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.
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At baseline visit and at 3-month study visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa Scarton, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201902145
- OCR35482 (Other Identifier: University of Florida)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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