The Life InSight Application Study (LISA) (LISA)
The Life InSight Application Study: the Role of an Assisted Structured Reflection on Life Events and Ultimate Life Goals to Improve Quality of Life of Cancer Patients
Background:
It is widely recognised that spiritual care plays an important role in physical and psychosocial well-being of cancer patients but there is little evidence based research on the effects of spiritual care. The investigators will conduct the first randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application. The aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients.
Design:
Based on the findings of the investigators previous research, the investigators have developed a brief interview model that allows spiritual counselors to explore, explicate and discuss life events and ultimate life goals with cancer patients. To support the interview, the investigators created an e-application for a PC or a tablet. To examine whether this assisted reflection improves quality of life the investigators will conduct a randomized trial. Patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group. The intervention group will have two consultations with a spiritual counselor using the interview scheme supported by the e-application. The control group will receive care as usual. At baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life, spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health care consumption.
Discussion:
Having insight into one's ultimate life goals may help to cope with a life event such as cancer. This is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients' quality of life and spiritual well being. The intervention is brief and based on concepts and skills that spiritual counselors are familiar with, it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Noord-Holland
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Amsterdam、Noord-Holland、荷兰
- Academic Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients ≥ 18 years of age with advanced cancer not amenable to curative treatment.
- Life expectancy ≥ 6 months.
Exclusion Criteria:
- Karnofsky Performance Score < 60.
- Insufficient command of the Dutch language to fill out Dutch questionnaires.
- Current psychiatric disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Control group
The control group receives care as usual.
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实验性的：Consultations
An intervention of two consultations with a spiritual counselor supported by an e-application.
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The patients receive two consultations with a spiritual counsellor.
In these consultations life evens and life goals are discussed.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of life
大体时间：4 months
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The EORTC QLQ C15 is a questionnaire developed to assess the quality of life of palliative cancer care patients.
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4 months
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Spiritual well being
大体时间：4 months
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FACIT-Sp-12: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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patients empowerment
大体时间：4 months
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Patient empowerment is becoming more and more important, both from health care professionals' and from patients' perspective.
The patients in the intervention arm of our study will reconstruct a life story and also define their life goals and their intention for the future.
This can lead to a feeling of more empowerment to undertake actions which are important to the patient.
We will assess patients' empowerment with a Dutch version of the Pearlin Mastery Scale developed by Pearlin en Schooler (1978).
The Pearlin Mastery Scale measures the extent to which individuals perceive themselves in control of forces that significantly impact their lives.
It consists of a 7-item scale.
In previous studies, the instrument yielded satisfactory psychometric properties.
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4 months
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spirituality
大体时间：4 months
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Furthermore, as time patients' view on spirituality can change over time due to the intervention, we will measure spirituality by the Spiritual Attitude en Interests List (SAIL), developed by the Helen Dowling Institute in the Netherlands.
The SAIL is a multidimensional questionnaire for studying spiritual experiences of religious and nonreligious people.
Mean Cronbach's alphas ranged in research from .73 to .86.
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4 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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anxiety and depression
大体时间：4 months
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Changes in patients' perspective on satisfaction with life will be measured by the Diener Satisfaction with Life Scale.
Furthermore, asfeelings of anxiety and depression may come up when patients realize the limited amount of time that is left to achieve life goals, feelings of anxiety and depression will be measured by the Hospital Anxiety and Depression Scale.
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4 months
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patients' health consumption
大体时间：4 months
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Patients' health consumption is assessed according to a shortened and for this study adjusted version of the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness.
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4 months
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patients'satisfaction with the intervention
大体时间：4 months
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Finally, we will explore patients' satisfaction with the intervention by a telephone interview using a study-specific topic list.
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4 months
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satisfaction with life
大体时间：4 months
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Changes in patients' perspective on satisfaction with life will be measured by the Diener Satisfaction with Life Scale
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4 months
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合作者和调查者
调查人员
- 首席研究员：Hanneke WM Laarhoven, van, MD, PhD、Acadamic Medical Center
出版物和有用的链接
一般刊物
- Kruizinga R, Scherer-Rath M, Schilderman JB, Hartog ID, Van Der Loos JP, Kotze HP, Westermann AM, Klumpen HJ, Kortekaas F, Grootscholten C, Bossink F, Schrama J, Van De Vrande W, Schrama NA, Blokland W, De Vos FY, Kuin A, Meijer WG, Van Oijen MG, Sprangers MA, Van Laarhoven HW. An assisted structured reflection on life events and life goals in advanced cancer patients: Outcomes of a randomized controlled trial (Life InSight Application (LISA) study). Palliat Med. 2019 Feb;33(2):221-231. doi: 10.1177/0269216318816005. Epub 2018 Dec 5.
- Kruizinga R, Scherer-Rath M, Schilderman JB, Sprangers MA, Van Laarhoven HW. The life in sight application study (LISA): design of a randomized controlled trial to assess the role of an assisted structured reflection on life events and ultimate life goals to improve quality of life of cancer patients. BMC Cancer. 2013 Jul 26;13:360. doi: 10.1186/1471-2407-13-360.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- W12-143#12.17.0161
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