Impact of a Gratitude-based Intervention on Patients and Caregivers in a Palliative Care Context: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in relationship quality for patients and caregivers
研究概览
简要总结
This is a pilot study consisting of mixed-methods, pre-post evaluation of a gratitude intervention (gratitude letter and visit) on palliative care patients and their caregivers.
详细描述
Study background and aims:
Gratitude, defined as an "other-oriented" emotion, has shown to impact significantly on many relevant dimensions for palliative care (e.g. well-being, psychological distress and the quality of relationships). Various psychological interventions focused on the enhancement of the feeling of gratitude have been developed and assessed but mostly in non-clinical populations and never taking into account the relationship dimension as an outcome.
The fact that the relational component has never been addressed in interventional studies is all the more surprising since several experimental and non-clinical studies have clearly shown an association between gratitude and feeling of social affiliation, relational commitment, satisfaction with relationships or partner reciprocal maintenance behaviours. These results appear to be very promising for palliative care since interpersonal (and particularly familial) relationships are crucial for palliative care patients: the relational sphere represents a major predictor contributing to both their meaning in life and their quality of life. We hypothesize that considering this concept in palliative care could benefit both the patients and their relatives.
Thus, the purpose of this research is to conduct a pilot study before a possible randomized controlled multicenter trial whose final aim will be to examine whether a gratitude-based intervention in a palliative care setting can increase the quality of life and the quality of the relationship of patients and their caregivers and decrease their psychological distress and burden.
The specific aims of this pilot study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Only patients fulfilling all of the following inclusion criteria are eligible for the study:
- •progressive disease
- •reduced life expectancy
- •enrolment in palliative care
- •stable state for the previous 24h assessed by the physician or the nurse in charge of the patient
- •informed consent signed by patient
- •For each patient, the identification of a close family or friend caregiver (fulfilling the below criteria*) and who accepts to participate in the trial (by signing an informed consent)
- •In this research, a caregiver is defined as "a person who devotes time to help a family member or a friend affected in her/his health or autonomy. The caregiver assures, in a non-professional and regular way, a presence and a support to help her/him in his difficulties and assures her/his safety. The caregiver can be a friend, a family member or a neighbour" (Vaud canton definition). This definition will be the basis for the palliative patient to identify his caregiver.
- •The presence of any one of the following
排除标准
- •will lead to exclusion of the patient:
- •Person completely isolated socially, no family or friend caregiver identified
- •Significant cognitive or psychiatric disorders which would affect the ability to give informed consent for this research
- •Severe communication problems (foreign language, deafness, etc.).
- •Only caregivers fulfilling all of the following inclusion criteria are eligible for the study:
- •Identified as the caregiver by the palliative patient (see above)
- •prior agreement of the patient for the participation of the caregiver
- •The presence of any one of the following exclusion criteria will lead to exclusion of the caregivers:
- •Psychiatric and cognitive disorders which would affect the ability to give informed consent for this research based on the information reported by the clinical team in charge of the patient and the personal evaluation of the research collaborator.
- •Communication problems (foreign language, deafness, etc.).
研究组 & 干预措施
Gratitude intervention
The intervention will be proposed to both the patient and the caregiver and consists of two steps: the "gratitude letter" and the "gratitude visit". In the "gratitude letter", the individual writes about his feelings of gratitude through a letter, based on a written instruction. The "gratitude visit" consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence.
干预措施: Gratitude intervention (Behavioral)
结局指标
主要结局
Change in relationship quality for patients and caregivers
时间窗: Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention
The quality of the relationship between the palliative patient and his/her caregiver will be measured with the Couple Satisfaction Index (CSI-4; "total score" range from 0 to 21, higher scores indicating a better quality of relationship).
次要结局
- Change in burden for patients(Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention)
- Change in burden for caregivers(Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention)
- Change in subjective quality of life for caregivers(Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention)
- Change in psychological distress for patients(Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention)
- Change in subjective quality of life for patients(Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention)
- Change in psychological distress for caregivers(Baseline approx. 5 days before intervention; post-intervention approx.10 days after intervention)
研究者
Mathieu BERNARD
Head of the Research Unit of the palliative and supportive care service
Centre Hospitalier Universitaire Vaudois