NCT06485310尚未招募不适用
Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients with a Primary Malignancy of the Central Nervous System Between the Announcement of the Diagnosis and the First Treatment
Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Distress thermometer
研究概览
简要总结
The goal of this clinal trial is to compare the effectiveness of nurse-led teleconsultation with usual care (intervention group) on psychological distress in patients with primary malignant tumors of the central nervous system between diagnosis and first anti-cancer treatment, versus usual care alone (control group).
Participants will be randomized into two groups :
- group A) intervention: usual care + nurse teleconsultation for psychological support
- group B) control: usual care alone
Enrolment = Day0 (D0)
Participants will :
- groups A and B: D0: complete 4 questionnaires (Quality of Life, Screening for Distress, Screening for Anxiety and Depression, Social Support Questionnaire)
- Group A : D0+2/4 das : nursing teleconsultation for psychological support
- Groups A and B: D0+10days : telephone call to complete the same 4 questionnaires as at inclusion
- Group A : D0+15days: semi-directive interview, at home, for voluntary patients.
详细描述
The expected benefits are as follows:
For the patient :
- Reduction in pre-treatment psychological distress
- Reduced pre-treatment anxiety and depression
- Better understanding of disease and treatments
- Better adherence to the care proposed in the treatment pathway
- Reduced stress during first hospital treatment
For healthcare professionals :
- Early detection of psychological distress
- Early detection of unmet needs and appropriate individualized responses
- Establishment of a climate of trust between patient and caregiver
- Improved professional practices
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
- 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
- •aged 18 and over
- •being treated for a primary malignant tumor of the central nervous system (positive biopsy)
- •with a Mini-Mental State score greater than 24
- •not receiving first-line treatment (chemotherapy, targeted radiotherapy, surgery)
- •with a distress score above 3 on the Psychological Distress Thermometer
- •have access to computer equipment equipped with a microphone and webcam (smartphone, computer)
- •able to read, write and speak French
- •have given free and informed consent
- •being affiliated to a social security scheme
排除标准
- •with a history of psychiatric illness
- •with recurrent cancer of the cerebral nervous system
- •having begun first-line treatment (drug therapy, curative surgery, radiotherapy or palliative care)
- •under guardianship, curatorship or deprived of liberty
结局指标
主要结局
Distress thermometer
时间窗: 10 days
Comparison of the change in psychological distress score, measured using the psychological distress screening tool (from National Comprehensive Cancer Network) between the 2 groups between inclusion (T0) and before the first anti-cancer therapy (T1).
次要结局
未报告次要终点
研究者
研究点 (2)
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