Breast CancerNCT05565534
Diabetes Care for Breast Cancer Patients
A study testing Nurse-practitioner led intervention in people with Breast Cancer and PreDiabetes, run by Weill Medical College of Cornell University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, PreDiabetes, Type 2 Diabetes
- What is being tested?
- Nurse-practitioner led intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Feb 2023to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients receiving hospice care
- Type 1 diabetes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
New York-Presbyterian Queens
Flushing, New York, 11355
Weill Cornell Medicine
New York, New York, 10021
About this study
Official title: Optimizing Delivery of Diabetes Management During Breast Cancer Care
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.
Read the 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.
- Conditions
- Breast Cancer, PreDiabetes, Type 2 Diabetes
- Being tested
- Nurse-practitioner led intervention
- Medical subject headings
- Breast Neoplasms, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-practitioner led interventionBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-practitioner led intervention group | Experimental | A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments Receives: Behavioral: Nurse-practitioner led intervention |
| Non-intervention (control) group | No intervention | Patient will not have access to the nurse practitioner led intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Success Ratio
Number of participants recruited divided by the number of participants approached
Measured: 2 years
Intervention Completion Ratio
(Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled.
Measured: 2 years
Data Collection Success Ratio
Number of participants who completed both surveys divided by the number of participants who were enrolled.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 years
Secondary outcomes (11)
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
Measured: 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
Measured: 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)
Measured: 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.
Measured: From baseline to Week 12 follow-up
Average Number of Hospitalizations Since Study Enrollment
The average number of hospitalizations since study enrollment
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to Week ~12 follow-up
Chemo Dose Reduction
Whether or not participants had their chemotherapy dose reduced
Measured: From baseline to Week ~12 follow-up
Most Recent HbA1c Level
Average last HbA1c level
Measured: From baseline to Week ~12 follow-up
Highest Glucose During Treatment
Average highest glucose measure during treatment
Measured: From baseline to Week ~12 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start28 Feb 2023
- Primary completion29 Jul 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura C Pinheiro, PhD, MPH, Principal investigator, Assistant Professor of Health Services Research in Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565534
- Sponsor's protocol ID
- 22-07025006
- Other IDs
- K01CA251645-01
- Status last verified
- Jun 2026
- First submitted
- 28 Sep 2022
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21130938Glasgow 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.
PubMed 10474547
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Delivery of Diabetes Management During Breast Cancer Care
- ClinicalTrials.gov ID
- NCT05565534
- Acronym / sponsor ID
- 22-07025006
- Conditions
- Breast Cancer, PreDiabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nurse-practitioner led intervention group | Experimental | Behavioral: Nurse-practitioner led interventionA nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments |
| Non-intervention (control) group | No intervention | –Patient will not have access to the nurse practitioner led intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed invasive cancer
- Plan to receive neo-adjuvant or adjuvant chemotherapy, targeted therapy, hormonal therapy, or radiation at Weill Cornell Medicine (WCM)
- 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
Key exclusion criteria (2 listed)
- Patients receiving hospice care
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Nurse-practitioner led intervention group |
Primary outcome
Recruitment Success Ratio
Time frame: 2 years
Number of participants recruited divided by the number of participants approached
Intervention Completion Ratio
Time frame: 2 years
(Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled.
Data Collection Success Ratio
Time frame: 2 years
Number of participants who completed both surveys divided by the number of participants who were enrolled.
Patient Questionnaire: Self-report of Intervention Feasibility
Time frame: Immediately post-intervention at the week ~12 follow-up
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.
Patient Questionnaire: Self-report of Intervention Acceptability
Time frame: Immediately post-intervention at the week 12 follow-up
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.
Patient Questionnaire: Self-report of Intervention Appropriateness
Time frame: Immediately post-intervention at the week 12 follow-up
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.
Ratio of Patients Who Had a Summary Document Created for Them at the End of the Intervention
Time frame: 2 years
Number of patients who had a summary document created for them compared to the number of patients who complete the follow-up visit.
Mean Number of In-person, Virtual or Phone Contacts With the NP Per Participant.
Time frame: 2 years
This will assess the degree to which the intervention was implemented over the course of the study
11 secondary outcomes
Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire
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
Time frame: At week 12 follow-up visit
Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire
Time frame: From baseline to Week 12 follow-up
Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire
Time frame: From baseline to Week 12 follow-up
Average Number of Hospitalizations Since Study Enrollment
Time frame: From baseline to Week ~12 follow-up
Average Number of ED Visits Since Study Enrollment
Time frame: From baseline to Week ~12 follow-up
Average Number of Uncompleted Chemotherapy Sessions
Time frame: From baseline to Week ~12 follow-up
Proportion of Planned Chemo Session Completed (%)
Time frame: From baseline to Week ~12 follow-up
Chemo Dose Reduction
Time frame: From baseline to Week ~12 follow-up
Most Recent HbA1c Level
Time frame: From baseline to Week ~12 follow-up
Highest Glucose During Treatment
Time frame: From baseline to Week ~12 follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21130938Gearing 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.
- Background: PubMed 10474547Glasgow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura C Pinheiro, PhD, MPH principal investigator
Assistant Professor of Health Services Research in Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-practitioner led intervention in people with Breast Cancer and PreDiabetes, run by Weill Medical College of Cornell University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Success Ratio (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565534, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.