Impact of Glycemic Variability on Diabetes Self-care, Glycated Hemoglobin, Diabetes Distress, Fatigue, and Quality of Life in People With a Dual Diagnosis of Gastrointestinal Cancer and Diabetes After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Self-Care of Diabetes Inventory
研究概览
简要总结
In study phase 1, the investigators will prospectively examine the factors related to post-operative glycemic variability and its effect on outcomes in people with both DM and GI cancer after surgery. The study will also qualitatively understand the glycemic variability experiences and their associated symptoms and outcomes in people with both DM and GI cancer. In study phase 2, the investigators will develop and test the effects of the CGM-Assisted Reflection Education (CARE) program on adults with both DM and GI cancer post-surgery.
详细描述
Diabetes mellitus (DM) often coexists with gastrointestinal (GI) cancer, and poor post-operative glycemic control is hypothesized as a major cause of patients' worse health-related outcomes. No study to date has developed and tested a program that focuses on improving DM self-care through glycemic variability reflection using continuous glucose monitoring (CGM) in people with both GI cancer and DM after surgery. This study aims to (1) prospectively examine the relationships among factors influencing glycemic variability and outcomes (DM self-care, HbA1c, DM distress, fatigue, and quality of life) in adults with DM and GI cancer during the first year post-surgery; (2) qualitatively explore the glycemic variability experiences; and (3) develop and test the effects of the CGM-Assisted Reflection Education (CARE) program on DM self-care and the secondary outcomes. This study consists of two phases. Phase one will utilize a longitudinal mixed-methods design with 200 participants recruited from GI surgical outpatient departments, collecting data via structured questionnaires at four time points: before surgery, 3, 6, and 12 months post-surgery. Data will be analyzed using SPSS version 28 and Mplus version 8.6 under a structural equation modeling approach. A subsample of 21 participants will undergo semi-structured interviews for qualitative insights. In study phase two, the CARE program will be developed and tested using a randomized controlled trial design. A total sample of 60 participants (30 in each group) will be recruited and randomly assigned in a 1:1 ratio to the experimental and the control group. The experimental group will receive usual care plus the CARE program. The control group will receive usual care. Outcomes will be measured using the same set of questionnaires from phase one, and the data will be collected pre-intervention, 8 weeks, 3-, and 6 months after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Individuals who are planning to undergo GI cancer surgery according to their physician's advice
- •Diagnosed with diabetes mellitus
- •Aged 18 or above
- •Can communicate in Mandarin or Taiwanese
- •Agree to participate and sign the informed consent form
排除标准
- •People who are under active treatment for cancer other than GI cancer
- •Have a cognitive impairment
- •Do not know that they have GI cancer
- •Have medical-grade adhesives-related allergy (e.g., redness, swelling, heat, pain, itching, blisters or rash)
- •Diagnosed with thrombocytopenia or blood coagulation dysfunction
研究组 & 干预措施
Usual care + CARE program
For the intervention group, participants will receive usual care and will be scheduled for the first in-person session of the CARE program after completing the T0 questionnaires, and will complete the outcome measurements using structured questionnaires at T1: Post-test 1 (5 months after surgery), T2: Post-test 2(6 months after surgery), and T3: Post-test 3(9 months after surgery).
干预措施: CARE program (Behavioral)
Usual care + CARE program
For the intervention group, participants will receive usual care and will be scheduled for the first in-person session of the CARE program after completing the T0 questionnaires, and will complete the outcome measurements using structured questionnaires at T1: Post-test 1 (5 months after surgery), T2: Post-test 2(6 months after surgery), and T3: Post-test 3(9 months after surgery).
干预措施: Usual Care (Other)
Usual Care
The control group will receive usual care. After obtaining the participants' written informed consent, baseline data will be collected (T0), and will complete the outcome measurements using structured questionnaires at T1: Post-test 1 (5 months after surgery), T2: Post-test 2 (6 months after surgery), and T3: Post-test 3 (9 months after surgery).
干预措施: Usual Care (Other)
结局指标
主要结局
Self-Care of Diabetes Inventory
时间窗: before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery
The Self-Care of Diabetes Inventory total score ranges from 40 to 200, and higher scores mean better diabetes self-care.
次要结局
- Diabetes Distress Scale(before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery)
- Fatigue Symptom Inventory(before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery)
- European Organisation for Research and Treatment of Cancer Quality of Life(before surgery (T0), 3 (T1), 6 (T2), and 12 (T3) months post-surgery)