Palliative Care Interventions for Outpatients With Newly Diagnosed Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months
研究概览
简要总结
The aims of this project are to assess the feasibility of recruiting patients and delivering a nurse-led telephone based palliative care intervention for patients with newly diagnosed lung cancer and to assess if among patients with newly diagnosed lung cancer, the investigators can estimate the effect of a nurse-led telephone based palliative care intervention on quality-of-life, symptom burden and patient satisfaction.
详细描述
Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcomes measures will be collected at baseline, and 3 months.
The study will be performed at the VA Puget Sound Health Care System. The investigators will recruit individuals (n=40) with lung cancer over 1 year. The primary objective is to test the feasibility and acceptability of the intervention, and recruitment of subjects. The investigators will estimate the effect of a nurse-led telephone based palliative care intervention to improve quality-of-life, symptom burden and patient satisfaction. In addition, using validated instruments, the investigators will assess the potential effect size of the intervention on quality of provider communication and on clinician knowledge of patient preferences for life sustaining therapies. The results of this pilot study will inform a future randomized clinical trial to test the efficacy of the intervention on a larger scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed at the Puget Sound Health Care System with a primary diagnosis of lung cancer,
- •any cell type or stage,
- •diagnosed within 8 weeks of study enrollment.
- •Must have telephone access,
- •ability of understand English and
- •provide informed consent.
排除标准
- •Patients not eligible to participate in the study include those who are inpatients prior to randomization,
- •those who are under the care of palliative care or hospice at the time of randomization,
- •those who have severe mental health disorders,
- •those who are unable to speak directly with the nurse over the telephone,
- •or those that have the inability to provide informed consent. Investigators will recruit individuals (n=40) with lung cancer over a 12 month period.
结局指标
主要结局
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months
时间窗: Baseline and 3 months
Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.
次要结局
- Change From Baseline in Patient Satisfaction of Care at 3 Months(Baseline and 3 months)
- Change in Baseline Quality of Clinician Communication at 3 Months(Baseline and 3 months)
- Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months(Baseline and 3 months)