Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients Based on Symptom Management Theory
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Wound Size at day 42
研究概览
简要总结
Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life.
详细描述
Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus, and there is an interrelationship between the symptoms. The symptoms presented by patients have certain individual differences and vary with the stage of treatment and treatment effect, which bring different degrees of distress to patients and their families and seriously affect patients' prognosis and quality of life. It is found that wound symptoms such as malodor are significantly negatively correlated with the quality of life of patients with malignant fungating wounds. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. With the continuous improvement of cancer treatment level, patients' quality of life is more representative of cure and recovery than survival to some extent. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will take the symptom management theory as the guide, start from the actual needs of patients and combine with the actual clinical situation to construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life and make their lives dignified and meaningful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Age greater than or equal to 18 years old with pathologically confirmed diagnosis of breast cancer.
- •Tumor metastasis in the chest wall or other sites and rupture to form a malignant fungating wound with a wound area of at least 10cm2 or more.
- •Knowing of the cancer diagnosis. ④ Capable and willing to receive follow-up.
- •Informed consent and voluntary participation.
排除标准
- •Patients with mental illness or cognitive impairment and language expression deficiency.
- •Patients with extensive metastasis of cancer throughout the body to the chest, shoulders, back, arms, etc. and whose treatment was ineffective.
- •Patients at the end stage of death.
- •Patients who refused to participate in this study.
- •Withdrawal criteria:
- •Patients who developed serious complications during the study and were unable to continue the study.
- •Patients who died during the study. ③Patients who requested withdrawal on their own during the study.
结局指标
主要结局
Change from Baseline in Wound Size at day 42
时间窗: Baseline and day 42
described by "healing, improvement, maintenance, deterioration", where "wound healing" refers to 100% epithelialization of the wound, "wound improvement" refers to reduction of the wound area, "wound maintenance" refers to no change in the wound area, and "wound deterioration" refers to an increase in the wound area.
次要结局
- Change from Baseline in Wound symptoms at day 42(Baseline and day 42)
- Change from Baseline in Quality of life in breast cancer patients at day 42(Baseline and day 42)
- Change from Baseline in Social support at day 42(Baseline and day 42)
- Change from Baseline in Anxiety at day 42(Baseline and day 42)
- Change from Baseline in Depression at day 42(Baseline and day 42)
- Change from Baseline in Stigma at day 42(Baseline and day 42)