Interest of Cognitive-behavioral Therapies Based on the CBSM (Cognitive Behavior Stress Management) for the Management of Patients Suffering From Pain Related to Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Measurement of emotional stress (PSS14)
研究概览
简要总结
The CBSM is a program combining cognitive and behavioral therapies, relaxation provided in groups of 8 to 10 patients. This program has demonstrated benefits in stress management skills, adaptive strategies, anxiety, quality of life, social inclusion, medication adherence, depression, therapeutic alliance, and general well-being. It would also improve breast cancer survival after adjuvant therapy. This program has been put in place at the center of pain for patients with cancer pain in any stage. This study aims to evaluate the benefits of this technique on a patient population suffering from chronic pain related to cancer.
详细描述
Methodology: Observational study, prospective, open, mono-centric, comparative, evaluating a psychosocial intervention type CBSM versus no intervention (group "waiting list").
Main Objective: To evaluate the impact of the implementation of a "CBSM" program on the stress management capacities of a pilot group of 30 patients followed at the pain center of Grenoble-Alpes University Hospital for chronic pain related to cancer or its treatment, compared to a control group "waiting list"
Primary Outcome: Measurement of emotional stress (PSS14)
Secondary objective:
Determine patients' interest in this program and the feasibility of the program.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Currently treated or treated for cancer (solid or otherwise), any stage combined.
- •With chronic pain related to cancer or its treatment
- •Never benefited from the management of stress by this technique
- •Knowing how to read, write and speak French
- •Person affiliated with social security or beneficiary of an equivalent plan.
排除标准
- •Life expectancy of less than 6 months
- •Patients unable to travel for 10 sessions on the structure
- •Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.
结局指标
主要结局
Measurement of emotional stress (PSS14)
时间窗: evaluation at the beginning of the meeting and at 9 weeks
assessment of the evolution of stress over a period of 3 months: Questionnaire PSS14
次要结局
- Inclusion rate(up to 18 months)
- Satisfaction(at 6 months)
- Pain Disability Index (PDI)(evaluation at the beginning of the meeting and at 9 weeks and then at 3 months)
- concise questionnaire on pain short version (QCD)(evaluation at the beginning of the meeting and at 9 weeks and then at 3 months)
- Measurement of quality of life(evaluation at the beginning of the meeting and at 9 weeks and then at 3 months)
- Hospital Anxiety and Depression Scale (HADS)(evaluation at the beginning of the meeting and at 9 weeks and then at 3 months)