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Diabetes Care Intervention for Breast Cancer Patients
N/A
Recruiting
Led By Laura C Pinheiro, PhD, MPH
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether having a nurse trained in diabetes care can help improve the care of patients with breast cancer and diabetes who are currently receiving chemotherapy treatment.
Who is the study for?
This trial is for adults over 18 with breast cancer and prediabetes or type 2 diabetes, who are about to start or currently receiving chemotherapy at Weill Cornell Medicine. It's not open to those with type 1 diabetes or patients in hospice care.
What is being tested?
The study is testing if a nurse-practitioner specializing in diabetes can improve care for breast cancer patients with diabetes during chemotherapy. Participants will be split into two groups: one receives this specialized nursing support, the other does not.
What are the potential side effects?
Since this trial involves standard care plus additional nursing support, there aren't new medical side effects expected from the intervention itself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Data Collection Success Ratio
Intervention Completion Success Ratio
Number of in-person, virtual or phone contacts with the NP
+8 moreSecondary study objectives
Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire
Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire
Change in Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nurse-practitioner led intervention groupExperimental Treatment1 Intervention
A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments
Group II: Non-intervention (control) groupActive Control1 Intervention
Patient will not have access to the nurse practitioner led intervention.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,087 Previous Clinical Trials
1,148,671 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,962 Total Patients Enrolled
Laura C Pinheiro, PhD, MPHPrincipal InvestigatorAssistant Professor of Health Services Research in Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving hospice care.I have pre-diabetes or type 2 diabetes, and may be on medication or have high blood sugar levels.I have Type 1 diabetes.I plan to undergo treatment before or after surgery at Weill Cornell Medicine.I am 18 years old or older.I have been recently diagnosed with invasive cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Nurse-practitioner led intervention group
- Group 2: Non-intervention (control) group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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