Breast Cancer Clinical Trial

Diabetes Care for Breast Cancer Patients

Summary

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 chemotherapy 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.

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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 ongoing chemotherapy.

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, ~12 weeks). Through chart review, the investigators will document chemotherapy 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 chemotherapy (~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 breast cancer care for patients undergoing chemotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed invasive breast cancer

Plan to receive neo-adjuvant or adjuvant chemotherapy 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

76

Study ID:

NCT05565534

Recruitment Status:

Not yet recruiting

Sponsor:

Weill Medical College of Cornell University

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There are 3 Locations for this study

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NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn New York, 11215, United States More Info
Evelyn Taiwo, M.D.
Contact
929-470-9600
[email protected]
Evelyn Taiwo, M.D.
Principal Investigator
New York-Presbyterian Queens
Flushing New York, 11355, United States More Info
Lauren Elreda, M.D.
Contact
718-670-1180
[email protected]
Lauren Elreda, M.D.
Principal Investigator
Weill Cornell Medicine
New York New York, 10021, United States More Info
Caroline Zeng, BA
Contact
646-962-5038
[email protected]
Laura Pinheiro, PhD, MPH
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

76

Study ID:

NCT05565534

Recruitment Status:

Not yet recruiting

Sponsor:


Weill Medical College of Cornell University

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