Construction and Empirical Study of Indirect Intervention Model for Protective Medical Lung Cancer Patients Based on Family System Theory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Decisional Conflict（DCS）
研究概览
简要总结
To clarify the irrational cognition of family caregivers of lung cancer patients at various perioperative stages under the background of protective medical treatment, construct an indirect intervention model for lung cancer patients, and evaluate its clinical efficacy.
To develop popularizable cognitive intervention tools and formulate practical cognitive intervention strategies, so as to relieve perioperative stress responses among lung cancer patients and their family caregivers.
To provide reliable evidence and research directions for carrying out comprehensive and systematic interventions on perioperative stress responses in lung cancer patients and their family caregivers in clinical practice in the future.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1)Patients
- •Eligible for radical lung cancer surgery confirmed by clinicians in accordance with lung cancer clinical guidelines;
- •Aged over 18 years old;
- •No history of drug or alcohol dependence, and no use of contraceptives or hormones within the past three months;
- •Fully informed of the study, signed informed consent and volunteered to participate.
- •(2)Family Caregivers
- •Spouses, adult children or other relatives who provide long-term unpaid daily care and companionship for patients;
- •Aged over 18 years old;
- •No history of drug or alcohol dependence, and no use of contraceptives or hormones within the past three months;
- •Fully informed of the study, signed informed consent and volunteered to participate.
排除标准
- •(1)Patients:
- •Patients who do not meet the surgical indications as evaluated by clinicians;
- •Patients with immune system diseases;
- •Patients with a history of mental illness or severe cognitive impairment.
- •(2)Family Caregivers：
- •Caregivers with severe organic lesions themselves;
- •Caregivers who have experienced other major life events recently;
- •Caregivers with a history of mental illness or severe cognitive impairment.
研究组 & 干预措施
Caregiver Control Group
Routine Care
干预措施: Routine health education (Behavioral)
Caregiver Intervention Group
Cognitive Intervention+Routine Care
干预措施: Caregiver cognitive intervention based on printed handbook (Behavioral)
Patient Control Group
Routine Care
干预措施: Routine perioperative health education (Behavioral)
Patient Intervention Group
Caregiver Cognitive Intervention+Routine Care
干预措施: Graded information disclosure strategies (Behavioral)
结局指标
主要结局
Decisional Conflict（DCS）
时间窗: 1 day before operation, 1 day after operation, and 1 month after discharge
Patient decisional conflict level is assessed using the validated 16-item Decisional Conflict Scale (DCS). Each item adopts a 5-point Likert rating with partial reverse scoring (1=strongly agree, 2=agree, 3=uncertain, 4=disagree, 5=strongly disagree). The mean raw score (1-5) of all items is linearly converted to a standardized total score of 0-100 via formula: (mean score-1)×25. Higher total scores indicate greater decisional conflict.
Functional status(FACT-L)
时间窗: 1 day before operation, 1 day after operation, and 1 month after discharge
Patient functional status and cancer-specific quality of life are measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L), containing 27 items across 4 general domains plus 9 lung-cancer-specific items. Each item is scored 0-4 points, domain scores are summed separately, and the overall total score ranges 0-144. Higher total scores represent better postoperative functional status and quality of life.
次要结局
- Anxiety and Depression(HADS)(1 day before operation, 1 day after operation, and 1 month after discharge)
- Blood Pressure(1 day before operation, 1 day after operation, and 1 month after discharge)
- Resilience(CD-RISC)(1 day before operation, 1 day after operation, and 1 month after discharge)
- BMI(1 day before operation, 1 day after operation, and 1 month after discharge)
- Lymphocyte count(1 day before operation, 1 day after operation, and 1 month after discharge)
研究者
Dan Su
Associate Professor
Anhui Medical University