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.
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
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
74
* 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.
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
New York-Presbyterian Queens
Flushing, New York, United States
Weill Cornell Medicine
New York, New York, United States
Recruitment Success Ratio
Number of participants recruited divided by the number of participants approached
Time frame: 2 years
Intervention Completion Ratio
(Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled.
Time frame: 2 years
Data Collection Success Ratio
Number of participants who completed both surveys divided by the number of participants who were enrolled.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Immediately post-intervention at the week 12 follow-up
Ratio of Patients Who Had a Summary Document Created for Them at the End of the Intervention
Number of patients who had a summary document created for them compared to the number of patients who complete the follow-up visit.
Time frame: 2 years
Mean Number of In-person, Virtual or Phone Contacts With the NP Per Participant.
This will assess the degree to which the intervention was implemented over the course of the study
Time frame: 2 years
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
Time frame: From baseline to week 12 follow-up visit
Severity of Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey at Follow-up
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
Time frame: At 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. (decrease in score means the item is considered less of a problem/bother)
Time frame: 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.
Time frame: From baseline to Week 12 follow-up
Average Number of Hospitalizations Since Study Enrollment
The average number of hospitalizations since study enrollment
Time frame: From baseline to Week ~12 follow-up
Average Number of ED Visits Since Study Enrollment
The average number of emergency department (ED) visits since study enrollment
Time frame: From baseline to Week ~12 follow-up
Average Number of Uncompleted Chemotherapy Sessions
Average number of planned chemo sessions that were not completed by participants
Time frame: From baseline to Week ~12 follow-up
Proportion of Planned Chemo Session Completed (%)
The proportion of planned chemo session completed during study enrollment, as a percentage
Time frame: From baseline to Week ~12 follow-up
Chemo Dose Reduction
Whether or not participants had their chemotherapy dose reduced
Time frame: From baseline to Week ~12 follow-up
Most Recent HbA1c Level
Average last HbA1c level
Time frame: From baseline to Week ~12 follow-up
Highest Glucose During Treatment
Average highest glucose measure during treatment
Time frame: From baseline to Week ~12 follow-up