Diabetes Care Intervention for Breast Cancer Patients

Recruiting at 2 trial locations

Overseen By Katherine Berg, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Antidiabetic medications

Disqualifiers: Hospice care, Type 1 diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

76 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Nurse-practitioner led intervention, Nurse-led diabetes care, Nurse-practitioner led diabetes intervention for breast cancer patients?

Research shows that nurse-led interventions can effectively manage diabetes, as seen in studies where nurse practitioners helped control blood sugar levels in patients with type 2 diabetes. This suggests that similar nurse-led approaches could be beneficial for breast cancer patients with diabetes. ^{1 2 3 4 5}

Is the Nurse-practitioner led diabetes intervention generally safe for humans?

The studies reviewed focus on the quality and feasibility of nurse-practitioner led diabetes care, but they do not provide specific safety data. However, the absence of reported safety concerns in these studies suggests that the intervention is generally considered safe in the contexts evaluated. ^{1 3 5 6 7}

How is the Nurse-practitioner led diabetes intervention unique for breast cancer patients with diabetes?

This treatment is unique because it involves nurse practitioners leading the care, focusing on personalized diabetes management through education, dietary advice, and medication adjustments, which is different from standard doctor-led approaches. ^{2 3 5 8 9}

What is the purpose of this trial?

The goal of this study is to find a new way to make diabetes care better for patients with breast cancer and diabetes who are currently receiving cancer treatment. We will have two groups, the researchers will decide who is in which group. One group will be working with a nurse who is trained in diabetes care while the other does not. This will allow the investigators to see if having a trained nurse as part of the care team can help improve the care the patients receive.

Research Team

Laura C Pinheiro, PhD, MPH

Principal Investigator

Assistant Professor of Health Services Research in Medicine

Eligibility Criteria

This trial is for adults over 18 with breast cancer and prediabetes or type 2 diabetes, who are about to start or currently receiving chemotherapy at Weill Cornell Medicine. It's not open to those with type 1 diabetes or patients in hospice care.

Inclusion Criteria

I have pre-diabetes or type 2 diabetes, and may be on medication or have high blood sugar levels.

I plan to undergo treatment before or after surgery at Weill Cornell Medicine.

I have been recently diagnosed with invasive cancer.

Exclusion Criteria

I am currently receiving hospice care.

I have Type 1 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cancer treatment while managing diabetes, with or without a nurse practitioner intervention

12 weeks

Regular visits as per cancer treatment schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment, including diabetes management outcomes

4 weeks

1 follow-up visit (in-person)

Data Collection

Collection of data on intervention feasibility, acceptability, and appropriateness

2 years

Treatment Details

Interventions

• Nurse-practitioner led intervention

Trial Overview The study is testing if a nurse-practitioner specializing in diabetes can improve care for breast cancer patients with diabetes during chemotherapy. Participants will be split into two groups: one receives this specialized nursing support, the other does not.

Participant Groups

Group I: Nurse-practitioner led intervention group Experimental Treatment 1 Intervention

A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments

Group II: Non-intervention (control) group Active Control 1 Intervention

Patient will not have access to the nurse practitioner led intervention.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A nurse practitioner-led outpatient clinic successfully managed the transition of 71 patients with diabetes from hospital to community care, providing timely interventions and follow-up within 3 to 21 days post-discharge.

The clinic effectively addressed issues such as hypoglycemia management and medication adjustments, demonstrating its feasibility as a safe transition option, although communication with family physicians about diabetes management plans needs improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nurse Practitioner-Led Multidisciplinary Diabetes Clinic for Adult Patients Discharged From Hospital. Roschkov, S., Chik, CL.[2021]

Nurse-led clinics significantly improve hemoglobin A1c (HbA1c) control in type 2 diabetes patients compared to standard care, with a strong effect size (SMD = -0.767) across various settings.

Nurse-led prescriptions are equally effective as doctor prescriptions for managing HbA1c levels, suggesting that nurses can play a vital role in diabetes care, especially when physician availability is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of nurse-led clinic and nurse-led prescription on hemoglobin A1c control in type 2 diabetes: A meta-analysis. Wang, Q., Shen, Y., Chen, Y., et al.[2022]

Involving nurse practitioners (NPs) in diabetes management before elective surgery led to significantly lower fasting blood glucose levels on the day of surgery, with a mean of 153.4 mg/dL in the NP phase compared to 171.4 mg/dL in the control group.

The NP-mediated intervention also increased patient access to care, with 93% of patients receiving intervention in phase 2, suggesting that NPs can effectively enhance preoperative diabetes control strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse practitioner-mediated intervention for preoperative control of diabetes in elective surgery patients. Garg, R., Metzger, C., Rein, R., et al.[2017]

The introduction of a nurse practitioner in primary care teams significantly improved the process quality of diabetes management, particularly in foot exams and HbA1c testing, based on a study of 132 patients.

While the process of care improved, the study did not find significant evidence of better glycemic control, indicating that while quality indicators were met, further research is needed to confirm improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of care for patients with diabetes mellitus type 2 in 'model practices' in Slovenia - first results. Petek, D., Mlakar, M.[2022]

An evaluation of 150 patient charts across five Nurse Practitioner-Led Clinics showed that the care provided for patients with diabetes and other chronic conditions was generally complete, indicating effective management in this healthcare model.

The study found no significant links between patient or organizational characteristics and the completeness of diabetes care, suggesting that the quality of care may be consistent regardless of these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Care for Patients With Diabetes and Mulitmorbidity Registered at Nurse Practitioner-Led Clinics. Heale, R., Wenghofer, E., James, S., et al.[2019]

Nurse practitioner-led clinics (NPLCs) in Ontario are designed to enhance access to primary healthcare, particularly for patients with diabetes and multimorbidity, and the study confirmed that nurse practitioners serve as the primary care providers in these settings.

Challenges such as stagnant NP salaries, insufficient healthcare resources, and high patient vulnerability negatively impact the quality of care at NPLCs, suggesting that strategies like mentoring could help improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multiple-Case Study in Nurse Practitioner-Led Clinics: An Exploration of the Quality of Care for Patients with Multimorbidity. Heale, R., James, S., Garceau, ML.[2019]

There is now a wide range of treatment options available for type 2 diabetes (T2D) beyond lifestyle changes and metformin, allowing for better blood glucose control and additional benefits like reduced risk of hypoglycemia and weight gain.

Nurse practitioners can tailor treatment plans to individual patient needs, improving compliance and outcomes, which may help slow the progression of T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic choices, and the nurse practitioner's role, in type 2 diabetes when metformin alone is no longer enough. Tierney, K.[2022]

In a study of 43 insulin-treated diabetic patients with poor glycemic control, 63% achieved improved HbA1c levels after intervention by diabetes specialist nurses, indicating the effectiveness of this approach.

Despite the overall success, 37% of patients did not improve and even experienced a deterioration in their HbA1c levels, suggesting that targeted interventions may be necessary for those more likely to respond positively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving glycaemic control of insulin-treated diabetic patients--a structured audit of specialist nurse intervention. Yong, A., Power, E., Gill, G.[2022]

A care model led by practice nurses significantly enhances the uptake of insulin treatment in patients with type 2 diabetes, indicating a potential improvement in diabetes management.

This approach suggests that involving practice nurses in diabetes care can lead to better treatment adherence and outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led model boosts uptake of type 2 diabetes treatment. [2019]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Nurse Practitioner-Led Multidisciplinary Diabetes Clinic for Adult Patients Discharged From Hospital. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Impacts of nurse-led clinic and nurse-led prescription on hemoglobin A1c control in type 2 diabetes: A meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Nurse practitioner-mediated intervention for preoperative control of diabetes in elective surgery patients. [2017]

4. Poland pubmed.ncbi.nlm.nih.gov

Quality of care for patients with diabetes mellitus type 2 in 'model practices' in Slovenia - first results. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Quality of Care for Patients With Diabetes and Mulitmorbidity Registered at Nurse Practitioner-Led Clinics. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

A Multiple-Case Study in Nurse Practitioner-Led Clinics: An Exploration of the Quality of Care for Patients with Multimorbidity. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Therapeutic choices, and the nurse practitioner's role, in type 2 diabetes when metformin alone is no longer enough. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Improving glycaemic control of insulin-treated diabetic patients--a structured audit of specialist nurse intervention. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nurse-led model boosts uptake of type 2 diabetes treatment. [2019]