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Trial Title:
Diabetes Care for Breast Cancer Patients
NCT ID:
NCT05565534
Condition:
Breast Cancer
PreDiabetes
Type 2 Diabetes
Conditions: Official terms:
Breast Neoplasms
Diabetes Mellitus
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
This is a quasi-experimental study with non-randomized intervention and control groups. A
nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage
diabetes for breast cancer patients undergoing cancer treatments. The control group will
be enrolled first, followed by the experimental group.
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Nurse-practitioner led intervention
Description:
- Face-to-face or virtual consultation with NP during chemotherapy infusion with
individualized recommendations/medications AND patient education through the Patient
Activated Learning System (PALS).
- Weekly follow-ups from NP via phone, Zoom, or in-person (patient directed) for 12
weeks/course of chemotherapy.
Arm group label:
Nurse-practitioner led intervention group
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 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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NewYork-Presbyterian Brooklyn Methodist Hospital
Address:
City:
Brooklyn
Zip:
11215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Evelyn Taiwo, M.D.
Phone:
929-470-9600
Email:
eot9002@med.cornell.edu
Investigator:
Last name:
Evelyn Taiwo, M.D.
Email:
Principal Investigator
Facility:
Name:
New York-Presbyterian Queens
Address:
City:
Flushing
Zip:
11355
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Elreda, M.D.
Phone:
718-670-1180
Email:
lae2014@med.cornell.edu
Investigator:
Last name:
Lauren Elreda, M.D.
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medicine
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Caroline Zeng, BA
Phone:
646-962-5038
Email:
caz4007@med.cornell.edu
Investigator:
Last name:
Laura Pinheiro, PhD, MPH
Email:
Principal Investigator
Start date:
February 28, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05565534
