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临床试验/NCT01141933
NCT01141933Unknown不适用

Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life

CHU de Quebec-Universite Laval6 个研究点 分布在 1 个国家目标入组 513 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
513
试验地点
6
主要终点
Existential quality of life

研究概览

简要总结

The purpose of this study is to test the efficacy of a cognitive-existential intervention (using either an individual or a group format) to improve the existential and global quality of life of patients as compared to usual care in a population of adult non-metastatic cancer patients.

详细描述

People diagnosed with cancer must learn to cope with loss of meaning and empowerment which compromises quality of life. Questions regarding "Why me?", along with universal existential concerns about death, search for meaning, and sense of control over one's life, often constitute the principal source of overall suffering. Since there is no single and identifiable cause for cancer, those existential questions are commonly observed among patients who demand specific interventions to properly address this central issue. The existential approach can be used to help patients find meaning in the midst of a crisis. It addresses a central issue of survivorship in cancer.

The conceptual model explains the relation between being exposed to a stressful and traumatic life event such as cancer and the risk of progressing toward adjustment difficulties which compromises quality of life and existential integrity. Cancer constitutes a major stressor involving significant losses that confronts the person's beliefs system. A set of therapeutic strategies can help to cope with this inevitable challenge: 1) cognitive-behavioral strategies; 2) direct existential intervention; and 3) social support through supportive-expressive strategies. Adjustment first involves cognitive reframing of the perception of the situation (situational meaning). Cognitive reframing also contributes to a readjustment of personal beliefs and values (global meaning and existential dimension). Existential strategies enable to further this process by including cognitive (beliefs, sense of coherence, expectations), motivational (choice, goal setting, and goal driving) and affective dimensions. The expressive-supportive strategy promotes active listening and non-judgmental support to encourage expression of emotions. The use of these active coping strategies (meaning-based) to the threatened-life challenge enables optimization of existential and global quality of life, as opposed to employing passive strategies such as avoidance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
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

  • •Be of 18 years of age or more;
  • •Speak French;
  • •Have received a diagnosis of non-metastatic cancer;
  • •Be available to participate in the program of 12 weekly group or individual sessions.

排除标准

  • •Depressive mood (score greater than 10 on the Hospital Anxiety and Depression Scale depressive subscale) that could interfere with the intervention. Since we specifically target the existential dimension and it might temporarily provoke questioning in patients, high psychological distress must first be addressed using other approaches.
  • •Diagnosis of metastatic cancer or diagnosis of non-metastatic cancer with a usually fast-growing and unpredictable course, making it unlikely to adhere to the intervention (e.g., pancreatic cancer, acute leukemia, glioblastoma).

研究组 & 干预措施

Usual care

Other

Subjects in this group receive the usual treatment only.

干预措施: Usual care (Other)

Individual intervention

Experimental

Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.

干预措施: Cognitive-existential intervention (Other)

Group intervention

Experimental

Consisting in a 12 weekly sessions with two therapists. Number of subjects in each group is from 5 to 10. Each session lasts 2 hours.

干预措施: Cognitive-existential intervention (Other)

结局指标

主要结局

Existential quality of life

时间窗: T5: Last follow-up measure (12 months after the end of the intervention)

Existential quality of life

时间窗: T2: End of the intervention (12 weeks after the beginning of the intervention)

Existential quality of life

时间窗: T3: First follow-up measure (3 months after the end of the intervention)

Existential quality of life

时间窗: T0: Pre-intervention

At every time frame, we use two questionnaires to measure the primary outcome: 1. The McGill Quality of Life Questionnaire (MQOL): 16 items plus a single-item global scale. 2. Spiritual well-being (FACIT-SP): The FACIT-SP is a sub-scale of the FACT-G (Functional Assessment of Cancer Therapy-General) and a French version of the "FACIT-SP, FACIT-Spiritual well-being scale". This questionnaire has two sub-scales: Meaning/Peace (8 items) and Faith (4 items).

Existential quality of life

时间窗: T1: Mid-intervention (6 weeks after the beginning of the intervention)

Existential quality of life

时间窗: T4: Second follow-up measure (6 months after the end of the intervention)

次要结局

  • Global quality of life(T5: Last follow-up measure (12 months after the end of the intervention))
  • Global quality of life(T1: Mid-intervention (6 weeks after the beginning of the intervention))
  • Global quality of life(T2: End of the intervention (12 weeks after the beginning of the intervention))
  • Global quality of life(T0: Pre-intervention)
  • Global quality of life(T3: First follow-up measure (3 months after the end of the intervention))
  • Global quality of life(T4: Second follow-up measure (6 months after the end of the intervention))

研究者

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre Gagnon

MD, FRCPC, Psychiatrist

CHU de Quebec-Universite Laval

研究点 (6)

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