Breast Cancer, PreDiabetes, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALNurse-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.
Sponsors
Weill Medical College of Cornell University
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Success Ratio | 2 years | Number of participants recruited divided by the number of participants approached |
| Intervention Completion Ratio | 2 years | (Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled. |
| Data Collection Success Ratio | 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 | 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 | 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 | 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 | 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. | 2 years | This will assess the degree to which the intervention was implemented over the course of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire | From baseline to week 12 follow-up visit | Diabetes Treatment Satisfaction Questionnaire (8 items) DTSQ, score 0-36; higher scores reflecting higher satisfaction |
| Severity of Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey at Follow-up | At week 12 follow-up visit | 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 |
| Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire | From baseline to Week 12 follow-up | 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) |
| Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire | From baseline to Week 12 follow-up | 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. |
| Average Number of Hospitalizations Since Study Enrollment | From baseline to Week ~12 follow-up | The average number of hospitalizations since study enrollment |
| Average Number of ED Visits Since Study Enrollment | From baseline to Week ~12 follow-up | The average number of emergency department (ED) visits since study enrollment |
| Average Number of Uncompleted Chemotherapy Sessions | From baseline to Week ~12 follow-up | Average number of planned chemo sessions that were not completed by participants |
| Proportion of Planned Chemo Session Completed (%) | From baseline to Week ~12 follow-up | The proportion of planned chemo session completed during study enrollment, as a percentage |
| Chemo Dose Reduction | From baseline to Week ~12 follow-up | Whether or not participants had their chemotherapy dose reduced |
| Most Recent HbA1c Level | From baseline to Week ~12 follow-up | Average last HbA1c level |
| Highest Glucose During Treatment | From baseline to Week ~12 follow-up | Average highest glucose measure during treatment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura C Pinheiro, PhD, MPH
Assistant Professor of Health Services Research in Medicine
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.257 Years STANDARD_DEVIATION 10.322 |
| Educational Attainment College degree | 7 Participants |
| Educational Attainment Graduate degree | 9 Participants |
| Educational Attainment High school degree or less | 16 Participants |
| Educational Attainment Some college | 8 Participants |
| Health Insurance (Private/Public) Medicaid | 10 Participants |
| Health Insurance (Private/Public) Medicare | 30 Participants |
| Health Insurance (Private/Public) Medicare & Medicaid | 3 Participants |
| Health Insurance (Private/Public) Private | 13 Participants |
| Marital Status Married/Domestic Partnership | 9 Participants |
| Marital Status Single | 14 Participants |
| Marital Status Widowed/Divorced/Separated | 30 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latinx | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Asian | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 14 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other/Multiple Races | 0 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 33 |
| other Total, other adverse events | 0 / 36 | 0 / 33 |
| serious Total, serious adverse events | 0 / 36 | 0 / 33 |
Outcome results
None listed