Diabetes Care for Breast Cancer Patients

NCT05565534 | Completed

• 2 other identifiers: 22-07025006K01CA251645-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer; PreDiabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire

  From baseline to week 12 follow-up visit

• Change in Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey

  From baseline to week 12 follow-up visit

• Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire

  From baseline to Week 12 follow-up

• Change in Patient Self-report Responses of the Audit of Diabetes Dependent QoL Questionnaire

  From baseline to Week 12 follow-up

• Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire

  From baseline to Week 12 follow-up

Study Arms (2)

Nurse-practitioner led intervention group

EXPERIMENTAL

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

Non-intervention (control) group

NO INTERVENTION

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

Interventions

Nurse-practitioner led intervention BEHAVIORAL

* 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.

Nurse-practitioner led intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients receiving hospice care
• Type 1 diabetes

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

New York-Presbyterian Queens

Flushing, New York, 11355, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 21130938 BACKGROUND

• 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.

  PMID: 10474547 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laura C Pinheiro, PhD, MPH

  Assistant Professor of Health Services Research in Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 4, 2022
• Study Start: February 28, 2023
• Primary Completion: July 29, 2025
• Study Completion: October 6, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)