Clinical trial · Interventional
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
NCT04468243CI-TRIAL-00057371terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nurse-led diabetes care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nurse-led
- 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.
- interventionNames
- Other: Nurse-led diabetes care
- type
- NO_INTERVENTION
- label
- Usual Care
- 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.
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.