Group Intervention for Adjustment to Primary Brain Tumour in Neuro-Oncological Disorders: A Randomized Single Group Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Adjustment to illness (as assessed by Mini-MAC score)
研究概览
简要总结
Background:
In the recent decade, psycho-oncology has gained wider attention worldwide, with exploration into the nuances of health and specific theoretical foundations has provided major insights for designing and implementing evidence-based interventions. However, group interventions as a powerful modality and medium of change has not been used before in the context of psycho-oncology in NIMHANS and seldom implemented in the cancer centres in the country with a plan of outcome measurement and analysis. The current study aims to address the psychological, social, and behavioural needs, challenges, and risks of major mood(affective) disorders among adults with neuro-oncological care.
Methodology:
**Aim:**“To study the effects of group intervention with respect to Adjustment to Primary Brain Tumour and other associated measures among adults with Neuro-Oncological Disordersâ€. **Objectives:**1. To develop an indigenous Group intervention module for adults with neuro-oncological disorders (i.e., primary brain tumours). 2. To assess the feasibility of the Group intervention and acceptability of scales for persons with neuro-oncological disorders (i.e., primary brain tumours). 3. To implement the group intervention and assess the changes in symptom burden, adjustment to illness and health-related quality of life of persons with neuro-oncological disorders (i.e., primary brain tumours). **Research design:**The study is based on a mixed method research design has two phases. First phase would entail qualitative methodology consisting of Interviews and Focus Group Discussions to construct manual of group intervention, where sample size would depend upon data saturation. In the second phase a single group trial (without control) would be conducted where 75 patients would be allotted to group intervention (each group consisting of at least6 sessions) in hybrid mode with active data collection in 6 months. The patient groups would be followed up after 1 month and 3 months period through telephonic/online/in-person medium.
**Keywords:**Brain Tumour, Adjustment to Illness, Cancer care. Quality of Life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who can follow English, Hindi, Tamil, Kannada.
排除标准
- •FOR PATIENTS.
- •i) Patients diagnosed with metastatic brain tumour as per histopathological report. ii) Patients with history of neuro-developmental disorders leading to mental retardation. iii) Patients with organic mental illness, i.e. phenomena known to occur as a direct consequence of malignant entity’s interaction with brain in form of growth of tumour; i.e., screening tool HMSE score below
- •iv) Patients experiencing cognitive impairment as a consequence/sequela of pharmacological or neurosurgical interventions for disorders; i.e., screening tool HMSE score below
- •FOR EXPERTS.
- •i) Non-academicians, i.e., those working professionals below the cadre of lecturer/assistant professor.
结局指标
主要结局
Adjustment to illness (as assessed by Mini-MAC score)
时间窗: 1. Baseline i.e. at pre-surgery stage, before the first group intervention session. | 2. One week from the baseline, i.e. after the last group intervention session. | 3. Follow-up after four weeks from the date of surgery. | 4. Follow-up after twelve weeks from the date of surgery.
次要结局
- Symptom burden (of psychological issues, as assessed by DASS-21 score)(1. Baseline i.e. at pre-surgery stage, before the first group intervention session.)
- Quality of life (health related, asassessed by CDC HrQOL-14 score)(1. Baseline i.e. at pre-surgery stage, before the first group intervention session.)
研究者
Hubert Dan V
National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru