Palliative Care for Quality of Life and Symptom Concerns in Early Stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Resource use as measured by chart audits
研究概览
简要总结
RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer.
PURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage I, stage II, or stage IIIA non-small cell lung cancer that can be removed by surgery.
详细描述
OBJECTIVES:
- To compare the effects of palliative care intervention (PCI) vs standard care on overall quality of life and psychological distress in patients with resectable stage I-IIIA non-small cell lung cancer.
- To compare symptom control in these patients.
- To compare geriatric assessment outcomes, as measured by OARS (Older Americans Resources and Services) Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS (Medical Outcomes Study)Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale, in these patients.
- To compare the effects of the PCI vs standard care on resource use.
- To identify subgroups of patients who benefit most from the PCI in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12.
OUTLINE: Patients assigned to 1 of 2 groups.
- Group I (standard care): Patients receive standard care. Patients complete questionnaires at baseline and at 6, 12, 24, 36, and 52 weeks to evaluate quality of life (QOL), symptoms, psychological distress, and geriatric assessments. A medical chart review is performed at 52 weeks to assess the progression of treatment, episodes of care, and re-admissions.
- Group II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention combining patient-centered teaching principles and concepts that are learner-centered (builds on the strengths, interests, and needs of the learner), knowledge-centered (teacher is proficient in the content being taught), assessment-centered (learners are given an opportunity to test their understanding and receive feedback), and community-centered (opportunities are available for continued learning and support). Patients undergo 4 teaching sessions (based on the patient-centered teaching principles and concepts) that focus on physical, psychological, social, and spiritual well-being, respectively, once a week in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9-21 to clarify questions or review concerns from the teaching sessions and to coordinate follow-up resources as needed. Patients also complete questionnaires as in group I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Diagnosis of stage I-IIIA resectable NSCLC - Undergoing either lobectomy, pneumonectomy, segmentectomy, or wedge resection
- •Living within a 50 mile radius of the City of Hope
- •No previous cancer within the past 5 years
排除标准
- •Diagnosis of stage II-III NSCLC that are not resectable based on clinical and individual characteristics (co-morbidities, extent of disease, bulky mediastinal lymph nodes [N2], etc.)
- •NSCLC patients receiving radiofrequency ablation
研究组 & 干预措施
Phase 1 Usual care
干预措施: questionnaire administration (Other)
Phase 1 Usual care
干预措施: end-of-life treatment/management (Procedure)
Phase 1 Usual care
干预措施: psychosocial assessment and care (Procedure)
Phase 1 Usual care
干预措施: quality-of-life assessment (Procedure)
Phase 2 Intervention
干预措施: educational intervention (Other)
Phase 2 Intervention
干预措施: medical chart review (Other)
Phase 2 Intervention
干预措施: questionnaire administration (Other)
Phase 2 Intervention
干预措施: end-of-life treatment/management (Procedure)
Phase 1 Usual care
干预措施: medical chart review (Other)
Phase 2 Intervention
干预措施: psychosocial assessment and care (Procedure)
Phase 2 Intervention
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Resource use as measured by chart audits
时间窗: 1 year after study enrollment
Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale
时间窗: 1 year after study enrollment
Overall quality of life and psychological distress
时间窗: 1 year after study enrollment
Symptom control
时间窗: 1 year after study enrollment
Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12
时间窗: Week 12 after study enrollment
次要结局
未报告次要终点
