Study on the Impact of Family-Supported Palliative Care on Decision-Making Experience, Mental Attitude, and Quality of Life in Patients With Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-Lung (FACT-L)
研究概览
简要总结
This study aims to evaluate the clinical effectiveness and ethical implications of a family-supported palliative care model in patients with advanced lung cancer. A single-center, parallel-group randomized controlled trial was conducted, in which 110 eligible patients were randomly assigned to either a routine nursing care group or a family-supported palliative care group for an 8-week intervention period.
The intervention integrates structured family involvement, palliative care education, shared decision-making support, psychological counseling, symptom management, and nutritional guidance. The primary outcome is quality of life assessed by the Functional Assessment of Cancer Therapy-Lung (FACT-L). Secondary outcomes include decisional conflict (DCS), hope level (HHI), anxiety and depression (SAS/SDS), nutritional indicators (albumin and prealbumin), and pain- and inflammation-related biomarkers (substance P, prostaglandin E2, dopamine, and C-reactive protein).
This study seeks to determine whether structured family engagement can improve patient-centered outcomes, reduce decisional conflict, enhance psychological well-being, and support ethically sound shared decision-making in the context of advanced cancer care.
详细描述
This study was designed as a single-center, parallel-group randomized controlled trial to investigate the effects of a structured family-supported palliative care intervention on decision-making experience, psychological status, and quality of life in patients with advanced lung cancer.
A total of 110 patients with pathologically or cytologically confirmed advanced lung cancer were enrolled and randomly assigned in a 1:1 ratio to either the control group or the intervention group. The control group received routine oncology nursing care, while the intervention group received an integrated family-supported palliative care program in addition to routine care. The intervention lasted for 8 weeks.
The family-supported palliative care model consisted of multiple components, including structured palliative care education for patients and family members, guided shared decision-making discussions, emotional support and companionship, therapeutic recreational activities, continuous communication and follow-up support, individualized pain management, and nutritional support. Family members were actively involved in the care process to enhance communication, emotional support, and decision-making alignment.
Outcome measures were assessed at baseline and at the end of the 8-week intervention. The primary outcome was quality of life measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). Secondary outcomes included decisional conflict measured by the Decisional Conflict Scale (DCS), hope level assessed using the Herth Hope Index (HHI), psychological status evaluated by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), nutritional indicators including serum albumin and prealbumin, and pain- and inflammation-related biomarkers such as substance P, prostaglandin E2, dopamine, and C-reactive protein.
This study also explores the ethical implications of family participation in end-of-life care, particularly in balancing patient autonomy with family involvement. By integrating structured family engagement into clinical practice, the study aims to provide evidence for improving patient-centered care and optimizing shared decision-making in advanced cancer management.
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
- •Pathologically or cytologically confirmed diagnosis of advanced lung cancer (stage III-IV or limited prognosis).
- •Age ≥ 18 years.
- •Receiving initial or first-line systemic treatment.
- •Fully informed of the diagnosis, with normal cognitive function and ability to communicate effectively.
- •Able to complete questionnaires and assessments.
- •Provided written informed consent.
排除标准
- •Prior exposure to more than one line of systemic antitumor therapy.
- •Severe cognitive impairment or diagnosed psychiatric disorders affecting compliance.
- •Severe comorbid conditions (cardiac, hepatic, or renal dysfunction) with life expectancy < 3 months.
- •Conditions that may interfere with outcome assessment, such as active infection or systemic inflammatory diseases.
结局指标
主要结局
Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-Lung (FACT-L)
时间窗: Baseline to 8 weeks
Quality of life was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. The outcome was defined as the change in total FACT-L score from baseline to the end of the 8-week intervention period. Higher scores indicate better quality of life.
次要结局
- Change in Decisional Conflict Measured by Decisional Conflict Scale (DCS)(Baseline to 8 weeks)
- Change in Hope Level Measured by Herth Hope Index (HHI)(Baseline to 8 weeks)
- Change in Anxiety Measured by Self-Rating Anxiety Scale (SAS)(Baseline to 8 weeks)
- Change in Depression Measured by Self-Rating Depression Scale (SDS)(Baseline to 8 weeks)
- Change in Nutritional Status (Serum Albumin and Prealbumin)(Baseline to 8 weeks)
- Change in Pain- and Inflammation-Related Biomarkers (SP, PGE2, DA, CRP)(Baseline to 8 weeks)