Study of the Impact of Non-pharmacological Techniques (Self-hypnosis/Self-care) on the Well-being, Cognitive Complaints and Return-to-work in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Change in objective cognitive difficulties : Verbal long term memory
研究概览
简要总结
Cancer diagnosis generates a number of physical (pain, nausea and fatigue) and psychological implications for the patient. At the psychological level, there are high levels of emotional distress (anxiety and depression) and cognitive impairments such as memory, attentional and information processing deficits, that can undermine the quality of life. This last decade has shown great progress in cancer treatment allowing cancer patients, many of whom are of working age, to survive. Unfortunately, cancer diagnosis and treatment induce various symptoms necessitating the patient to interrupt or quit his occupational status. Hypnosis has been used in the past few years to treat these psychological and physical symptoms, be it at the moment of diagnosis, during and/or after the cancer treatments. A large amount of studies has shown a positive effect of hypnosis in cancer patients notably upon anxiety, emotional distress and fatigue, three factors that can negatively affect cognitive functions. The purpose of our study is to investigate the effect of a non-pharmacological treatment that combines self-hypnosis and self-care on well-being, cognitive complaints and return-to- work within a population of cancer patients. Our hypothesis is that, by reducing emotional distress and fatigue, self-hypnosis/self-care will reduce the cognitive difficulties of cancer patients, foster return-to-work, and eventually improve the patients' global quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The investigator will not know which participant is in the learning phase or in the waiting list.
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
- •Fluency in French
- •End of surgery and/or chimiotherapy and/or radiotherapy : 1-12 months.
- •Cognitive complaints
排除标准
- •Brain cancer
- •Metastatic cancer
- •Psychiatric disorder
- •Neurologic disorder
- •Neuropsychological assessment made within 3 months
- •Drug addiction
- •Alcoholism
结局指标
主要结局
Change in objective cognitive difficulties : Verbal long term memory
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on verbal long term memory will be assessed by means the Buschke Selective Reminding Test (Buschke, 1973). According to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitvie difficulties : Inhibition
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on inhibition abilities will be assessed by means of the first part of the Stroop test (Stroop, 1935). According to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitvie difficulties : executive functions
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on executive functions will be assessed by means of the Wisconsin Card Sorting Test (David et al., 1948). According to the sex and the subject's age, the test gives us a score and the norms.
Impact on return-to-work
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
For people who continued to work at time of recruitment, Work Design questionnaire will be administered Morgeson \& Hymphrey, 2006). Scale raging from 0 to 5 (0=not at all; 5=exactly).
Change in subjective cognitive difficulties : Perceived cognitive abilities
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Perceived cognitive abilities" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=not at all; 4=very much).
Change in subjective cognitive difficulties : Impact on quality of life
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Impact on quality of life" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=not at all; 4=very much).
Change in objective cognitvie difficulties : working memory
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on mental flexibility abilities will be assessed by means of the subtest "Working memory" of the Test of Attentional Performance 2.3.1 (Zimmermann \& Fimm, 2002). Computerized test, according to the sex and the subject's age, the test gives us a score and the norms.
Change in subjective cognitive difficulties : Perceived cognitive impairments
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Perceived cognitive impairments" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=never; 4=several times a day).
Change in subjective cognitive difficulties : Comments by others
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on the perceived cognitive impairments will be assessed by means of the subtest "Comments by others" of the Functionnal Assessment of Cancer Therapy-Cognitive Function (FACT-COG; Wagner et al., 2009). Scale ranging from 0 to 4 (0=never; 4=several times a day).
Change in objective cognitive difficulties : Attention
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on attention abilities will be assessed by means of the subtest "Phasic alertness" of the Test of Attentional Performance 2.3.1 (Zimmermann \& Fimm, 2002). Computerized test, according to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitive difficulties : Processing speed
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on processing speed abilities will be assessed by means of the first part of the Stroop test (Stroop, 1935). According to the sex and the subject's age, the test gives us a score and the norms.
Change in objective cognitvie difficulties : mental flexibility
时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up)
The impact of self-hypnosis/self-care on mental flexibility abilities will be assessed by means of the subtest "Flexibility" of the Test of Attentional Performance 2.3.1 (Zimmermann \& Fimm, 2002). Computerized test, according to the sex and the subject's age, the test gives us a score and the norms.
次要结局
- Change in fatigue : General fatigue(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in emtional distress : Anxiety(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in quality of life(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in fatigue(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in fatigue : Mental fatigue(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in emtional distress : Depression(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in fatigue : Physical fatigue(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in fatigue : Motivational decrease(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
- Change in fatigue : Weekly agenda(T1 (before the intervention), T2 (right after the intervention), T3 (3 months follow-up))
研究者
Audrey Vanhaudenhuyse
PhD
University of Liege