A nurse‐led intervention in patients with newly diagnosed cancer and Type 2 diabetes: A pilot randomized controlled trial feasibility study

• Published in: Cancer medicine (Malden, MA) Vol. 12; no. 11; pp. 12874 - 12880
• Main Authors: Scarton, Lisa, Nelson, Tarah, Jo, Ara, O’Neal, LaToya J., Yao, Yingwei, Huggins, Shavondra, Legaspi, Anatolia B., McClaren, Mariah J., Cabassa, Jake S., Burgos Melendez, Joan M., Munoz‐Pena, Juan M., Markham, Merry J., Murphy, Martina C., Chatzkel, Jonathan A., Rogers, Sherise, George, Thomas J.
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01-06-2023; John Wiley and Sons Inc; Wiley
• Subjects: Adult; Brief Communication; Cancer; Cell cycle; Chemotherapy; clinical management; Clinical trials; community outreach; Consent; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - diagnosis; Diabetes Mellitus, Type 2 - drug therapy; Education; Efficiency; Electronic health records; Feasibility Studies; Glucose; Glycated Hemoglobin; Humans; Life span; medical oncology; Medical prognosis; Metformin; Metformin - therapeutic use; Mortality; Neoplasms - diagnosis; Neoplasms - drug therapy; Nurse's Role; Oncology; Patient satisfaction; Pilot Projects; Primary care; screening; Smoking; Sociodemographics; Software; clinical management; medical oncology; screening; clinical trials; community outreach
• ISSN: 2045-7634; 2045-7634
• DOI: 10.1002/cam4.6118

Background
Undiagnosed Type 2 diabetes (T2D) has been associated with advanced stage cancer at diagnosis, higher mortality, and lower long‐term all‐cause survival. This was a RCT pilot study to examine the feasibility of a nurse‐led T2D intervention for adults with newly diagnosed cancer (≤3 months), and T2D, undiagnosed or untreated with medication, conducted at an outpatient oncology clinic affiliated with a large academic institution.
Methods
Participants needed to meet the eligibility criteria including a HbA1c level between 6.5% and 9.9%. Randomization was 1:1 to a 3‐month intervention that consisted of nursing‐led diabetes education and immediate initiation of metformin versus referral to primary care for usual care (control).
Results
Three hundred and seventy nine patients were screened using EHR, 55 agreed to participate, and 3 had eligible HbA1c levels and were randomized in the study. Primary reasons for study exclusion included life expectancy ≤2 years (16.9%), current use or inability to tolerate metformin (14.8%), and abnormal labs that contraindicated metformin use (13.9%).
Conclusion
This study was not feasible due to recruitment inefficiencies, but acceptable to all who qualified.
Undiagnosed Type 2 diabetes (T2D) has been associated with advanced stage cancer at diagnosis, higher mortality, and lower long‐term all‐cause survival. This was a pilot RCT study to examine the feasibility of a nurse‐led T2D intervention for adults with newly diagnosed cancer (=3 months), and T2D, undiagnosed or untreated with medication, conducted at an outpatient oncology clinic affiliated with a large academic institution. This study was not feasible due to the cost, time, and personnel needed to screen participants with a point‐of‐care HbA1c test.