Optimizing Delivery of Diabetes Management During Breast Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Provider Questionnaire: Self-report of intervention feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients receiving hospice care
- •Type 1 diabetes
研究组 & 干预措施
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
干预措施: Nurse-practitioner led intervention (Behavioral)
Non-intervention (control) group
Patient will not have access to the nurse practitioner led intervention.
结局指标
主要结局
Provider Questionnaire: Self-report of intervention feasibility
时间窗: 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.
Provider Questionnaire: Self-report of intervention acceptability
时间窗: 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.
Intervention Completion Success Ratio
时间窗: 2 years
Only for the interventional group The number of participants who completed intervention divided by the number of participants who enrolled
Data Collection Success Ratio
时间窗: 2 years
Number of participants who completed both surveys divided by the number of participants who were enrolled.
Patient Questionnaire: Self-report of intervention acceptability
时间窗: 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.
Recruitment Success Ratio
时间窗: 2 years
Number of participants recruited divided by the number of participants approached
Patient Questionnaire: Self-report of intervention feasibility
时间窗: 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 appropriateness
时间窗: 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.
Provider Questionnaire: Self-report of intervention appropriateness
时间窗: 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 receive a summary document at the end of the intervention
时间窗: 2 years
Number of patients who receive a summary document compared to the number of patients who complete the follow-up visit.
Number of in-person, virtual or phone contacts with the NP
时间窗: 2 years
This will assess the degree to which the intervention was implemented over the course of the study
Intervention Completion Ratio
时间窗: 2 years
(Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled.
Patient Questionnaire: Self-report of Intervention Feasibility
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 2 years
This will assess the degree to which the intervention was implemented over the course of the study
次要结局
- Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire(From baseline to week 12 follow-up visit)
- Change in Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey(From baseline to week 12 follow-up visit)
- Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire(From baseline to Week 12 follow-up)
- Change in number of Hospitalizations Since Cancer Diagnosis(From baseline to Week 12 follow-up)
- Number of missed chemotherapy doses(From baseline to Week 12 follow-up)
- Number of participants with a Delay in Chemotherapy Administration(From baseline to Week 12 follow-up)
- Number of participants with Chemotherapy Dose Reductions(From baseline to Week 12 follow-up)
- Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire(From baseline to Week 12 follow-up)
- Severity of Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey at Follow-up(At week 12 follow-up visit)
- Average Number of Hospitalizations Since Study Enrollment(From baseline to Week ~12 follow-up)
- Average Number of ED Visits Since Study Enrollment(From baseline to Week ~12 follow-up)
- Average Number of Uncompleted Chemotherapy Sessions(From baseline to Week ~12 follow-up)
- Proportion of Planned Chemo Session Completed (%)(From baseline to Week ~12 follow-up)
- Chemo Dose Reduction(From baseline to Week ~12 follow-up)
- Most Recent HbA1c Level(From baseline to Week ~12 follow-up)
- Highest Glucose During Treatment(From baseline to Week ~12 follow-up)
- Number of missed chemotherapy doses(From baseline to Week 12 follow-up)
- Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire(From baseline to week 12 follow-up visit)
- Change in Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey(From baseline to week 12 follow-up visit)
- Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire(From baseline to Week 12 follow-up)
- Change in Patient Self-report Responses of the Audit of Diabetes Dependent QoL Questionnaire(From baseline to Week 12 follow-up)
- Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire(From baseline to Week 12 follow-up)
- Change in number of Hospitalizations Since Cancer Diagnosis(From baseline to Week 12 follow-up)
- Change in number of Emergency Department (ED) Visits Since Cancer Diagnosis(From baseline to Week 12 follow-up)
- Number of participants with a Delay in Chemotherapy Administration(From baseline to Week 12 follow-up)
- Number of participants with Chemotherapy Dose Reductions(From baseline to Week 12 follow-up)