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 chemotherapy 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.

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 ongoing chemotherapy. 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, ~12 weeks). Through chart review, the investigators will document chemotherapy 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 chemotherapy (~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 breast cancer care for patients undergoing chemotherapy.

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.

A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments

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.

Only for the interventional group The number of participants who completed intervention divided by the number of participants who enrolled

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

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.

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.

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.

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.

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.

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.

Number of patients who receive a summary document compared to the number of patients who complete the follow-up visit.

Diabetes Treatment Satisfaction Questionnaire (8 items) DTSQ, score 0-36; higher scores reflecting higher satisfaction

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

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.

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.

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.

Inclusion Criteria: Newly diagnosed invasive breast cancer Plan to receive neo-adjuvant or adjuvant chemotherapy 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

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