Pilot RCT Feasibility Study: Cancer and T2D

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04468243
• Other study ID #: IRB201902145
• Secondary ID: OCR35482
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: March 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Diabetes Mellitus, Type 2

Intervention

Other:
• Nurse-led diabetes care
Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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