Clinical trial NCT05565534: Diabetes Care for Breast Cancer Patients
Official title: Optimizing Delivery of Diabetes Management During Breast Cancer Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
PreDiabetes
Type 2 Diabetes
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-10-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Success Ratio
timeFrame: 2 years
measure: Intervention Completion Success Ratio
timeFrame: 2 years
measure: Data Collection Success Ratio
timeFrame: 2 years
measure: Patient Questionnaire: Self-report of intervention feasibility
timeFrame: Immediately post-intervention at the week 12 follow-up
measure: Provider Questionnaire: Self-report of intervention feasibility
timeFrame: Immediately post-intervention at the week 12 follow-up
measure: Patient Questionnaire: Self-report of intervention acceptability
timeFrame: Immediately post-intervention at the week 12 follow-up
measure: Provider Questionnaire: Self-report of intervention acceptability
timeFrame: Immediately post-intervention at the week 12 follow-up
measure: Patient Questionnaire: Self-report of intervention appropriateness
timeFrame: Immediately post-intervention at the week 12 follow-up
measure: Provider Questionnaire: Self-report of intervention appropriateness
timeFrame: Immediately post-intervention at the week 12 follow-up
measure: Ratio of patients who receive a summary document at the end of the intervention
timeFrame: 2 years
measure: Number of in-person, virtual or phone contacts with the NP
timeFrame: 2 years
Secondary outcomes:
measure: Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire
timeFrame: From baseline to week 12 follow-up visit
measure: Change in Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey
timeFrame: From baseline to week 12 follow-up visit
measure: Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire
timeFrame: From baseline to Week 12 follow-up
measure: Change in Patient Self-report Responses of the Audit of Diabetes Dependent QoL Questionnaire
timeFrame: From baseline to Week 12 follow-up
measure: Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire
timeFrame: From baseline to Week 12 follow-up
measure: Change in number of Hospitalizations Since Cancer Diagnosis
timeFrame: From baseline to Week 12 follow-up
measure: Change in number of Emergency Department (ED) Visits Since Cancer Diagnosis
timeFrame: From baseline to Week 12 follow-up
measure: Number of missed chemotherapy doses
timeFrame: From baseline to Week 12 follow-up
measure: Number of participants with a Delay in Chemotherapy Administration
timeFrame: From baseline to Week 12 follow-up
measure: Number of participants with Chemotherapy Dose Reductions
timeFrame: From baseline to Week 12 follow-up
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Flushing
country: United States
facility: New York-Presbyterian Queens
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Assistant Professor of Health Services Research in Medicine
name: Laura C Pinheiro, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.