Effectiveness of an Individual Mindfulness-based Intervention for Cancer Patients in a Advanced Stage of the Disease and Their Relatives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Mindfulness
研究概览
简要总结
The importance of emotional regulation interventions in cancer patients and primary caregivers is clearly established, since it helps them manage their emotions.
The aim of the study was to analyze the differential effect between two Emotional Support programs, one of them based on Mindfulness, and the other one Emotional Support as usual, on advanced cancer patients (stage III & IV) admitted to a Madrid Community Hospital La Paz and their relatives.
详细描述
It is clearly demonstrated that Emotional Regulation interventions are very important in cancer patients in any stage of the disease.
Great emotional burden has also been described in case of main caregivers and other relatives of the patients.
Diagnosis, treatment and survival of cancer patients are related to a complex set of stressors that have their own effects on the results of the treatments: activity daily life changes, social impairment, role changes, thought about the possibility of a relapse and possibility of death...
It has been elucidated that psychological interventions, as cognitive therapy or other types of psychotherapy, may improve the psychosocial outcomes (for example, quality of life).
During the last years, many researches have assessed the effect of Mindfulness interventions on cancer patients. Mindfulness is defined as the intention of paying full attention, moment to moment, to your experiences, without judgement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Older than 18 years old.
- •Being in treatment in one of the Oncology units at Hospital Universitario La Paz.
- •Capable of a minimum level of performance that allows intervention.
- •The doctor responsible of the patient considers that the program will help the cancer patient and that the patient is capable to participate on it.
- •Capable of understanding and giving his or her written informed consent.
排除标准
- •Intellectual disability or cognitive impairment or dementia.
- •Insufficient knowledge of the language to understand and participate on the intervention program.
- •Serious mental illness in acute state at the moment of the beginning of the intervention.
- •Autolytic ideas at the moment of the assessment.
结局指标
主要结局
Mindfulness
时间窗: At the end of the six sessions(each session is every three days)
Philadelphia Mindfulness Scale (PHLMS). Attention to the present moment and Acceptance.
次要结局
- Daily life Performance(At day one of the intervention)
- Emotional distress(At the end of the six sessions(each session is every three days))
- Caregiver emotional burden.(At the end of the six sessions(each session is every three days))
- Quality of life.(At the end of the six sessions(each session is every three days))
- Number of sessions(At the end of the six sessions(each session is every three days))