跳至主要内容
临床试验/NCT00823667
NCT00823667已完成不适用

Palliative Care for Quality of Life and Symptom Concerns in Early Stage Lung Cancer

City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: questionnaire administration (Other)

Phase 1 Usual care

Active Comparator

干预措施: end-of-life treatment/management (Procedure)

Phase 1 Usual care

Active Comparator

干预措施: psychosocial assessment and care (Procedure)

Phase 1 Usual care

Active Comparator

干预措施: quality-of-life assessment (Procedure)

Phase 2 Intervention

Active Comparator

干预措施: educational intervention (Other)

Phase 2 Intervention

Active Comparator

干预措施: medical chart review (Other)

Phase 2 Intervention

Active Comparator

干预措施: questionnaire administration (Other)

Phase 2 Intervention

Active Comparator

干预措施: end-of-life treatment/management (Procedure)

Phase 1 Usual care

Active Comparator

干预措施: medical chart review (Other)

Phase 2 Intervention

Active Comparator

干预措施: psychosocial assessment and care (Procedure)

Phase 2 Intervention

Active Comparator

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

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验