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Completed

NCT Number: NCT05565534

Diabetes Care for Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases PreDiabetes Prediabetic State Skin Diseases Skin and Connective Tissue Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Success Ratio

    Time frame: 2 years

    Number of participants recruited divided by the number of participants approached

  2. 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.

  3. Data Collection Success Ratio

    Time frame: 2 years

    Number of participants who completed both surveys divided by the number of participants who were enrolled.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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.

  5. Average Number of Hospitalizations Since Study Enrollment

    Time frame: From baseline to Week ~12 follow-up

    The average number of hospitalizations since study enrollment

  6. 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

  7. 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

  8. 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

  9. Chemo Dose Reduction

    Time frame: From baseline to Week ~12 follow-up

    Whether or not participants had their chemotherapy dose reduced

  10. Most Recent HbA1c Level

    Time frame: From baseline to Week ~12 follow-up

    Average last HbA1c level

  11. Highest Glucose During Treatment

    Time frame: From baseline to Week ~12 follow-up

    Average highest glucose measure during treatment

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Optimizing Delivery of Diabetes Management During Breast Cancer Care

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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