Impact on Survival of Chaplain Provided Spiritual Care or Psychotherapy Combined With Palliative Care Versus Palliative Care Alone in Patients With Non-Curative Malignancies
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 854
- 试验地点
- 2
- 主要终点
- To determine the overall survival (OS) of patients with non-curative malignancies
研究概览
简要总结
This phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to standard-of-care (SOC) and palliative measures, plus chemotherapy if recommended, and comparing it with SOC and palliative measures, plus chemotherapy if recommended, in patients with non-curative malignancies. The Palliative Care Department at Houston Methodist Hospital provides essential services to patients diagnosed with advanced cancer by sharing information and resources about symptom management, pain treatment and planning for the future. It is also recognized that chaplaincy-based spiritual care of patients can be a valuable part of interdisciplinary interventions in oncology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Patients are eligible to be included in the trial only if all of the following criteria apply
- •The patient provides written informed consent for the trial.
- •Male or female ≥18 years of age on the day of informed consent signing.
- •Histologically confirmed metastatic disease with life expectancy of one year or less.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Willing and able to comply with the protocol for the duration of the trial including undergoing scheduled visits and interventions.
排除标准
- •Patients are excluded from the trial if any of the following criteria apply:
- •Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. If a patient develops a psychiatric disorder after baseline, he/she will not be taken off the trial.
- •Mobility limitations that would interfere with cooperation with the requirements of the trial.
- •Confirmed positive pregnancy test in women of child bearing potential.
结局指标
主要结局
To determine the overall survival (OS) of patients with non-curative malignancies
时间窗: From start of intervention till the date of death, up to 30 days after completing intervention
To determine the overall survival (OS) of patients with non-curative malignancies who receive chaplain-provided spiritual care or psychotherapy/ meditation in addition to SOC and palliative measures, plus chemotherapy if recommended.
次要结局
- Patient-reported quality of life assessed by the FACT-G questionnaire.(Assessed at baseline and after interventions are completed, up to 24 weeks)
- Patient-reported quality of life assessed by the DASS-42 questionnaire.(Assessed at baseline and after interventions are completed, up to 24 weeks)
- Patient-reported quality of life assessed by the AAQ questionnaire.(Assessed at baseline and after interventions are completed, up to 24 weeks)
- Patient-reported quality of life assessed by the ACE questionnaire.(Assessed at baseline and after interventions are completed, up to 24 weeks)
- Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section C - Personal Achievement.(From initial assessment until final assessments are completed, every 6 months, up to 60 months)
- Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Burnout.(From initial assessment until final assessments are completed, every 6 months, up to 60 months)
- Patient-reported quality of life assessed by the FACIT-Sp-Ex questionnaire.(Assessed at baseline and after interventions are completed, up to 24 weeks)
- Self-reported caretaker/physician burnout as assessed by the PROMIS questionnaire.(From initial assessment until final assessments are completed, every 6 months, up to 60 months)
- Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section A - Burnout.(From initial assessment until final assessments are completed, every 6 months, up to 60 months)
- Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section B - Depersonalization.(From initial assessment until final assessments are completed, every 6 months, up to 60 months)
- Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Professional Fulfillment.(From initial assessment until final assessments are completed, every 6 months, up to 60 months)
研究者
Hanh Mai
Hematologist-Oncologist
The Methodist Hospital Research Institute