Diabetes Care for Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimizing Delivery of Diabetes Management During Breast Cancer Care

Conditions
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Breast Cancer, PreDiabetes, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Nurse-practitioner led intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-practitioner led intervention group<br>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<br>* 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.<br>|
| No Intervention: Non-intervention (control) group<br>Patient will not have access to the nurse practitioner led intervention. | |

What is the study measuring?
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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 |