Diabetes Care for Breast Cancer Patients

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Breast Cancer; Type 2 Diabetes; PreDiabetes

Treatments: Behavioral: Nurse-practitioner led intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05565534

K01CA251645-01 (U.S. NIH Grant/Contract)

22-07025006

Details and patient eligibility

About

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.

Full description

The present study aims to develop a stakeholder-engaged nurse practitioner (NP)-led intervention to improve diabetes care for patients with breast cancer and diabetes who are undergoing cancer treatment.

This is a pilot feasibility study, in which we will use a quasi-experimental pre-post design with non-randomized intervention and control groups. In this feasibility study, the investigators will first enroll 38 eligible patients for the control group and collect effectiveness measures at baseline and follow-up (end of chemotherapy or other cancer treatment, ~12 weeks). Through chart review, the investigators will document cancer treatment regimen completion at follow-up. The investigators will then enroll 38 patients for the intervention group, collecting the effectiveness and implementation outcomes at the end of their treatment (~12 weeks).

The main hypothesis that will be tested in this pilot study is that a nurse practitioner embedded in the oncology team who is trained in diabetes management may successfully manage diabetes during active cancer care for patients undergoing cancer treatment.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed invasive cancer

• Plan to receive neo-adjuvant or adjuvant chemotherapy, targeted therapy, hormonal therapy, or radiation at Weill Cornell Medicine (WCM)

  • Age 18+ years
  • Pre-diabetes OR type 2 diabetes. Treatment with antidiabetic medication OR

• HbA1c greater than or equal to 5.7 OR

• Random glucose greater than or equal to OR

• Fasting blood glucose greater than or equal to 100

Exclusion criteria

• Patients receiving hospice care
• Type 1 diabetes

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Nurse-practitioner led intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Nurse-practitioner led intervention

Non-intervention (control) group

No Intervention group

Description:

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