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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
2 other identifiers
interventional
3
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Apr 2021
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedMarch 28, 2022
March 1, 2022
9 months
July 8, 2020
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Nurse-led
EXPERIMENTALNurse-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
NO INTERVENTIONUsual 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.
Interventions
Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Scarton
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 13, 2020
Study Start
April 1, 2021
Primary Completion
December 13, 2021
Study Completion
December 13, 2021
Last Updated
March 28, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share