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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether including a nurse trained in diabetes care on the cancer treatment team can improve diabetes management for breast cancer patients. Participants will be divided into two groups: one with access to a specialized nurse and one without. The study targets individuals newly diagnosed with invasive breast cancer who have pre-diabetes or type 2 diabetes and are scheduled to receive cancer treatment at Weill Cornell Medicine. As an unphased trial, it offers patients the chance to contribute to innovative care strategies that could enhance diabetes management during cancer treatment.

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 prior data suggests that this nurse-practitioner led intervention is safe for breast cancer patients with diabetes?

Research shows that nurse-led diabetes care is generally safe and can improve patient health. Studies have found that these approaches better manage diabetes, resulting in lower blood sugar levels, improved patient understanding, and fewer hospital visits and deaths. Past studies reported no major safety concerns, indicating that patients handle this approach well. Overall, involving a nurse practitioner in managing diabetes alongside cancer treatment appears both safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nurse-practitioner led intervention because it offers a personalized approach to managing diabetes for breast cancer patients undergoing treatment. Unlike standard care, which often involves separate management of diabetes and cancer, this approach integrates diabetes care directly into the oncology team. The involvement of a nurse practitioner trained in diabetes ensures that patients receive expert attention tailored to their unique needs, potentially improving both cancer and diabetes outcomes. This holistic method could lead to better overall health and quality of life for patients facing the dual challenges of breast cancer and diabetes.

What evidence suggests that the nurse-practitioner led intervention is effective for diabetes care in breast cancer patients?

Research has shown that care led by nurse practitioners can significantly improve diabetes management in cancer patients. In this trial, participants in the nurse-practitioner-led intervention group will receive diabetes management support from a trained nurse practitioner on the oncology team. Studies have found that patients under nurse practitioners' care have lower blood sugar levels, a better understanding and confidence in managing their condition, and fewer hospital visits. These interventions are also linked to lower death rates in patients with both diabetes and cancer. For breast cancer patients with diabetes, this type of care may help reduce the higher risk of death associated with having both conditions. Overall, evidence suggests that including a trained nurse on the care team can lead to better health outcomes for these patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Laura C Pinheiro, PhD, MPH

Principal Investigator

Assistant Professor of Health Services Research in Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05565534

NCT05565534 | Diabetes Care for Breast Cancer Patients The present study aims to develop a stakeholder-engaged nurse practitioner (NP)-led intervention to improve diabetes care for patients with breast cancer and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9093555/

Managing diabetes during treatment for breast cancer In this qualitative study, we elicited the perspectives of 29 primary care and oncology providers on a NP-led intervention to manage diabetes among women with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9892662/

Diabetes and cancer co-management: patient-reported ... Patients with breast cancer and diabetes have a 50% increased risk of 10-year all-cause and breast cancer-related mortality compared to breast ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748922001183

Nursing interventions to promote patient engagement in ... This systematic review demonstrated significant positive effect of nurse-led engagement interventions on relevant outcomes for adults with cancer, such as ...

5. mdpi.com mdpi.com/2227-9032/13/7/738

Effectiveness of Advanced Practice Nursing Interventions ... Reported outcomes included reductions in HbA1c levels, improved patient self-knowledge and self-efficacy, and decreased rates of readmission and mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10855413/

The Influence of Nurse-Led Interventions on Diseases ... Interventions led by nurses can support PWD for effective management of diabetes, which can positively improve clinical outcomes. Nurse-led ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499267115300277

The Effect of Nurse Practitioner-Led Intervention in ... In this study, we evaluated the feasibility of a nurse practitioner-led outpatient clinic (NPC) to facilitate the safe transition of patients with diabetes ...

8. researchgate.net researchgate.net/publication/370951373_A_nurse-led_intervention_in_patients_with_newly_diagnosed_cancer_and_Type_2_diabetes_A_pilot_randomized_controlled_trial_feasibility_study

(PDF) A nurse-led intervention in patients with newly ... 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 ...