Diabetes Care for Breast Cancer Patients

June 10, 2026 updated by: Weill Medical College of Cornell University

Optimizing Delivery of Diabetes Management During Breast Cancer Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • NewYork-Presbyterian Brooklyn Methodist Hospital
      • Flushing, New York, United States, 11355
        • New York-Presbyterian Queens
      • New York, New York, United States, 10021
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse-practitioner led intervention group
A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments
Behavioral: Nurse-practitioner led intervention
  • 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.
No Intervention: Non-intervention (control) group
Patient will not have access to the nurse practitioner led intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Success Ratio
Time Frame: 2 years
Number of participants recruited divided by the number of participants approached
2 years
Data Collection Success Ratio
Time Frame: 2 years
Number of participants who completed both surveys divided by the number of participants who were enrolled.
2 years
Intervention Completion Ratio
Time Frame: 2 years
(Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled.
2 years
Patient Questionnaire: Self-report of Intervention Feasibility
Time Frame: Immediately post-intervention at the week ~12 follow-up

Questionnaire: Feasibility of Intervention Measure (4 items)

Response Scale:

For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating that the intervention is very feasible, and lower scores (below 3) indicating the intervention is not feasible.
Immediately post-intervention at the week ~12 follow-up
Patient Questionnaire: Self-report of Intervention Acceptability
Time Frame: Immediately post-intervention at the week 12 follow-up

Questionnaire: Acceptability of Intervention Measure (4 items)

Response Scale:

For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating more favorable attitudes toward the intervention and lower scores (below 3) indicating less favorable attitudes.
Immediately post-intervention at the week 12 follow-up
Patient Questionnaire: Self-report of Intervention Appropriateness
Time Frame: Immediately post-intervention at the week 12 follow-up

Questionnaire: Intervention Appropriateness Measure (4 items)

Response Scale:

For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating the intervention suits their needs well and lower scores (below 3) indicating the intervention does not fit their needs well.
Immediately post-intervention at the week 12 follow-up
Ratio of Patients Who Had a Summary Document Created for Them at the End of the Intervention
Time Frame: 2 years
Number of patients who had a summary document created for them compared to the number of patients who complete the follow-up visit.
2 years
Mean Number of In-person, Virtual or Phone Contacts With the NP Per Participant.
Time Frame: 2 years
This will assess the degree to which the intervention was implemented over the course of the study
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire
Time Frame: From baseline to week 12 follow-up visit
Diabetes Treatment Satisfaction Questionnaire (8 items) DTSQ, score 0-36; higher scores reflecting higher satisfaction
From baseline to week 12 follow-up visit
Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire
Time Frame: From baseline to Week 12 follow-up
Functional Assessment of Cancer Therapy -Breast (44-items) measures quality of life for patients with breast cancer. Total scores range from 0-148 with higher scores representing better quality of life.
From baseline to Week 12 follow-up
Severity of Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey at Follow-up
Time Frame: At week 12 follow-up visit

PRO-CTCAE: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

Neuropathy - PRO-CTCAE (2 items) 0-8 with higher scores representing worse neuropathy
At week 12 follow-up visit
Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire
Time Frame: From baseline to Week 12 follow-up
Diabetes Distress Scale (17 items) A score of "1" indicates a particular item is not a problem or bother for the patient, whereas "6" represents an item is very concerning for the patient. To score, the patient's responses will be summed and then divided by the number of items in that scale. A mean score of 3 or higher (moderate distress) is considered as a level of distress that is above average. (decrease in score means the item is considered less of a problem/bother)
From baseline to Week 12 follow-up
Average Number of Hospitalizations Since Study Enrollment
Time Frame: From baseline to Week ~12 follow-up
The average number of hospitalizations since study enrollment
From baseline to Week ~12 follow-up
Average Number of ED Visits Since Study Enrollment
Time Frame: From baseline to Week ~12 follow-up
The average number of emergency department (ED) visits since study enrollment
From baseline to Week ~12 follow-up
Average Number of Uncompleted Chemotherapy Sessions
Time Frame: From baseline to Week ~12 follow-up
Average number of planned chemo sessions that were not completed by participants
From baseline to Week ~12 follow-up
Proportion of Planned Chemo Session Completed (%)
Time Frame: From baseline to Week ~12 follow-up
The proportion of planned chemo session completed during study enrollment, as a percentage
From baseline to Week ~12 follow-up
Chemo Dose Reduction
Time Frame: From baseline to Week ~12 follow-up
Whether or not participants had their chemotherapy dose reduced
From baseline to Week ~12 follow-up
Most Recent HbA1c Level
Time Frame: From baseline to Week ~12 follow-up
Average last HbA1c level
From baseline to Week ~12 follow-up
Highest Glucose During Treatment
Time Frame: From baseline to Week ~12 follow-up
Average highest glucose measure during treatment
From baseline to Week ~12 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Laura C Pinheiro, PhD, MPH, Assistant Professor of Health Services Research in Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

July 29, 2025

Study Completion (Actual)

October 6, 2025

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-07025006
  • K01CA251645-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe