Diabetes Care for Breast Cancer Patients

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: Breast Cancer; PreDiabetes; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Nurse-practitioner led intervention

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Number of participants recruited divided by the number of participants approached	2 years
Intervention Completion Success Ratio	Only for the interventional group The number of participants who completed intervention divided by the number of participants who enrolled	2 years
Data Collection Success Ratio	Number of participants who completed both surveys divided by the number of participants who were enrolled.	2 years
Patient Questionnaire: Self-report of intervention feasibility	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
Provider Questionnaire: Self-report of intervention feasibility	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	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
Provider Questionnaire: Self-report of intervention acceptability	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	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
Provider Questionnaire: Self-report of intervention appropriateness	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 receive a summary document at the end of the intervention	Number of patients who receive a summary document compared to the number of patients who complete the follow-up visit.	2 years
Number of in-person, virtual or phone contacts with the NP	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	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 Neuropathy as Measured By the PRO-CTCAE Survey	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	From baseline to week 12 follow-up visit
Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire	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.	From baseline to Week 12 follow-up
Change in Patient Self-report Responses of the Audit of Diabetes Dependent QoL Questionnaire	Audit of Diabetes Dependent Quality of life (QoL) (15 items). For each item, respondents provide a score for both "impact" and "importance." Total weighted scores range from -9 to +3. Lower scores reflect poorer quality of life.	From baseline to Week 12 follow-up
Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire	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
Change in number of Hospitalizations Since Cancer Diagnosis		From baseline to Week 12 follow-up
Change in number of Emergency Department (ED) Visits Since Cancer Diagnosis		From baseline to Week 12 follow-up
Number of missed chemotherapy doses	# of doses given subtracted from total # planned doses	From baseline to Week 12 follow-up
Number of participants with a Delay in Chemotherapy Administration	# of days chemotherapy infusion was delayed from schedule date	From baseline to Week 12 follow-up
Number of participants with Chemotherapy Dose Reductions	From the electronic medical chart: Indication if chemotherapy dose was reduced	From baseline to Week 12 follow-up

Collaborators and Investigators

• 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

General Publications

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
• Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.

Study record dates

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 (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Skin Diseases; Breast Diseases; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus, Type 2; Breast Neoplasms; Prediabetic State
• 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