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| ID | Type | Description | Link |
|---|---|---|---|
| K01CA251645-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Non-intervention (control) group | No Intervention | Patient will not have access to the nurse practitioner led intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-practitioner led intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Success Ratio | Number of participants recruited divided by the number of participants approached | 2 years |
| Intervention Completion Ratio | (Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled. | 2 years |
| Data Collection Success Ratio | Number of participants who completed both surveys divided by the number of participants who were enrolled. | 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. | 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. | Immediately post-intervention at the week 12 follow-up |
| Patient Questionnaire: Self-report of Intervention Appropriateness |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Severity of Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey at Follow-up |
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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)
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:
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| Name | Affiliation | Role |
|---|---|---|
| Laura C Pinheiro, PhD, MPH | Assistant Professor of Health Services Research in Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States | ||
| New York-Presbyterian Queens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21130938 | Background | 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. | |
| 10474547 | Background | 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. |
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Each week, our study team reviewed multi-disciplinary tumor board lists to identify potential participants. Upon identifying these individuals, every Friday morning we sent the list of patients to the breast medical oncology team for review and approval. By the end of the day on Friday, we received an approved list of patients that we could approach for the study. Our team would then either call the patient by phone or approach them at their next medical oncology appointment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nurse-practitioner Led Intervention Group | A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments |
| FG001 | Non-intervention (Control) Group | Patient will not have access to the nurse practitioner led intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only those who completed the baseline survey were included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nurse-practitioner Led Intervention Group | A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments |
| BG001 | Non-intervention (Control) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant assigned to the intervention group declined to give their age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Success Ratio | Number of participants recruited divided by the number of participants approached | Posted | Number | patient recruited per patient approached | 2 years |
|
|
from enrollment until end of follow-up, up to 12 weeks
Per protocol, only individuals who signed the ICF and completed the baseline survey were included in AE data collection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nurse-practitioner Led Intervention Group | A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Pinheiro | Weill Cornell Medicine | 646-962-5898 | lcp2003@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2024 | Apr 22, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2022 | Apr 23, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Control Group | Nov 6, 2023 | Dec 9, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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|
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 |
| 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. | 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 | 2 years |
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 |
| 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) | 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. | From baseline to Week 12 follow-up |
| Average Number of Hospitalizations Since Study Enrollment | The average number of hospitalizations since study enrollment | 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 | 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 | 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 | From baseline to Week ~12 follow-up |
| Chemo Dose Reduction | Whether or not participants had their chemotherapy dose reduced | From baseline to Week ~12 follow-up |
| Most Recent HbA1c Level | Average last HbA1c level | From baseline to Week ~12 follow-up |
| Highest Glucose During Treatment | Average highest glucose measure during treatment | From baseline to Week ~12 follow-up |
| Flushing |
| New York |
| 11355 |
| United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Did not initiate study procedures |
|
Patient will not have access to the nurse practitioner led intervention. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | 1 participant assigned to the intervention group chose not to disclose their marital status. | Count of Participants | Participants |
|
| Educational Attainment | Count of Participants | Participants |
|
| Health Insurance (Private/Public) | Count of Participants | Participants |
|
|
| Primary | Intervention Completion Ratio | (Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled. | Per protocol, all participants in the intervention group who were enrolled were analyzed for this measure. | Posted | Number | pt. completed per pt. enrolled | 2 years |
|
|
|
| Primary | Data Collection Success Ratio | Number of participants who completed both surveys divided by the number of participants who were enrolled. | Posted | Number | completed pts per enrolled pt | 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. | Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-intervention at the week 12 follow-up |
|
|
|
| Primary | 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. | Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure. | Posted | Number | summary docs to f/u surveys | 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 | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | score on a scale | From baseline to week 12 follow-up visit |
|
|
|
|
| Secondary | 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 | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | score on a scale | At 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. (decrease in score means the item is considered less of a problem/bother) | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | score on a scale | From baseline to Week 12 follow-up |
|
|
|
|
| Secondary | Average Number of Hospitalizations Since Study Enrollment | The average number of hospitalizations since study enrollment | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | hospitalizations | From baseline to Week ~12 follow-up |
|
|
|
|
| Secondary | Average Number of ED Visits Since Study Enrollment | The average number of emergency department (ED) visits since study enrollment | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | ED visits | From baseline to Week ~12 follow-up |
|
|
|
|
| Primary | 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 | Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure. | Posted | Mean | Standard Deviation | contacts per patient | 2 years |
|
|
|
| Secondary | Average Number of Uncompleted Chemotherapy Sessions | Average number of planned chemo sessions that were not completed by participants | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | Uncompleted Chemo sessions | From baseline to Week ~12 follow-up |
|
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| Secondary | Proportion of Planned Chemo Session Completed (%) | The proportion of planned chemo session completed during study enrollment, as a percentage | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | % of planned chemo sessions completed | From baseline to Week ~12 follow-up |
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|
|
| Secondary | Chemo Dose Reduction | Whether or not participants had their chemotherapy dose reduced | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Number | participants | From baseline to Week ~12 follow-up |
|
|
|
|
| Secondary | Most Recent HbA1c Level | Average last HbA1c level | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | HbA1c | From baseline to Week ~12 follow-up |
|
|
|
|
| Secondary | Highest Glucose During Treatment | Average highest glucose measure during treatment | Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure. | Posted | Mean | Standard Deviation | mg/dL | From baseline to Week ~12 follow-up |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Non-intervention (Control) Group | Patient will not have access to the nurse practitioner led intervention. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Non-Hispanic Asian |
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| Hispanic/Latinx |
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| Other/Multiple Races |
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| Single |
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| College degree |
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| Graduate degree |
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| Medicaid |
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| Medicare & Medicaid |
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| This NP-led intervention for co-managing diabetes/pre-diabetes and breast cancer seems doable. |
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| This NP-led intervention for co-managing (pre)diabetes and breast cancer seems easy to carry out. |
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| I welcome this NP-led intervention to co-manage my diabetes/pre-diabetes and chemotherapy. |
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| This NP-led intervention seems like a good match for co-managing my (pre)diabetes and chemotherapy. |
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