A Nurse-led Intervention in Patients With Newly Diagnosed Cancer and Type 2 Diabetes: A Pilot RCT Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
The purpose of this study is to test a nurse-led intervention for adults with newly diagnosed cancer and undiagnosed/newly diagnosed Type-2 diabetes
详细描述
Specific Aim 1: To examine study feasibility of a nurse-led intervention for adults with newly diagnosed cancer and T2D. We define feasibility indicators as: (a) efficient study recruitment is possible given prevalence of T2D (diagnosed and undiagnosed) in UF patients with newly diagnosed cancer; (b) retention rates in both groups ≥80% to indicate that the study design and methods are adequately patient-centered; (c) identified barriers to and facilitators of a nurse-led intervention are respectively modifiable or optimizable; and (d) patient acceptability scores >8 for the study procedures. We hypothesize that we will recruit up to 40 patients within 18 months and retain ≥ 80% of patients in all groups; minor but important revisions will be required to resolve issues identified with using the nurse-led intervention; and 80% of patients from both groups who complete the study will report that the burden of the study is acceptable through their retention in the study.
Specific Aim 2: To determine the variation in HbA1c at baseline and at the end of the three-month intervention period in each of the two study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) 18 years and older
- •b) Using pathology reports, a new diagnosis of a solid tumor cancer or lymphoma within the past 3 months
- •c) Patients being treated with curative intent or those with a prognosis estimated to be >2 years, as best assessed by the oncologist.
- •d) First medical oncology outpatient visit at UF within the past 3 months
- •e) Plans to continue cancer care at UF
- •f) Speaks and reads English
- •g) Can comply with study related procedures, per the treating oncologist or advanced practice provider
排除标准
- •a) Diagnosis of leukemia or pancreatic cancer as the new cancer diagnosis
- •b) Being treated for T2D for > than 3 months
- •c) eGFR <45mL/minute/1.73m2
- •d) Liver insufficiency (defined as liver enzymes over 5 times the upper limit of normal or clinical sequelae of advanced cirrhosis as documented by the treating oncologist or Advanced Practice Providers.
- •e) Active infection requiring systemic antibiotics
- •f) Taking systemic steroids of more than 1-week duration. Must have stopped >3 days prior to study enrollment. Note, inhaled or topical steroids are not exclusion criteria.
- •g) Planning to receive cancer care at a location outside of UF
- •h) Enrolled in another study with similar outcomes.
- •i) Currently taking metformin or known inability to tolerate it
研究组 & 干预措施
Nurse-led
Nurse-led (group A). Patients randomized to group A will be taken to an available consultation room within the clinic and provided brief diabetes education which includes understanding what it means to have diabetes, healthy eating, and physical activity. Patients will also receive instructions on how to use a glucometer and how to take Metformin.
干预措施: Nurse-led diabetes care (Other)
Usual Care
Usual Care (Control; group B). Patients randomized to usual care will be informed of their HbA1c value, will continue to receive usual cancer care, and will be encouraged to follow-up with their PCP for T2D management. The RA will ensure that oncology visit clinic notes and the results of the HbA1c testing are relayed to the patient's PCP office. Patients who do not have a PCP identified will be referred to an appropriate provider.
结局指标
主要结局
Acceptability
时间窗: At 3-month study visit
Study acceptability (scores\>8 indicate adequate acceptability) will be measured via the Study Acceptability Scale questionnaire for both groups
Point of Care HbA1c Test
时间窗: At baseline visit and at 3-month study visit
To determine the variation in HbA1c at baseline and at the end of the three-month intervention period in each of the two study groups.
次要结局
未报告次要终点