Diabetes Care for Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Optimizing Delivery of Diabetes Management During Breast Cancer Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565534
• Other study ID #: 22-07025006
• Secondary ID: K01CA251645-01
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Weill Medical College of Cornell University
• Contact: Laura C Pinheiro, PhD, MPH
• Phone: 646-962-5898
• Email: lcp2003[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Diabetes Mellitus
• PreDiabetes
• Type 2 Diabetes

Intervention

Behavioral:
• Nurse-practitioner led intervention
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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Success Ratio	Number of participants recruited divided by the number of participants approached	2 years
Primary	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
Primary	Data Collection Success Ratio	Number of participants who completed both surveys divided by the number of participants who were enrolled.	2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in number of Hospitalizations Since Cancer Diagnosis		From baseline to Week 12 follow-up
Secondary	Change in number of Emergency Department (ED) Visits Since Cancer Diagnosis		From baseline to Week 12 follow-up
Secondary	Number of missed chemotherapy doses	# of doses given subtracted from total # planned doses	From baseline to Week 12 follow-up
Secondary	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
Secondary	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