Feasibility Study of a Remote Psychosocial Intervention for Brain Tumour Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- Change from baseline in score on Quality of Life score on the Functional Assessment of Cancer Therapy-Brain
研究概览
简要总结
Survivors of high grade brain tumours frequently experience increases in distress, cognitive challenges, and lessened quality of life. At the same time a range of barriers can make it challenging for these individuals to come into the clinic for appropriate psychosocial support. The proposed study is therefore a feasibility study that is designed to develop a manualized, remotely delivered psychosocial intervention for this population and then to test the acceptability, feasibility, apparent efficacy, and areas for improvement of the developed intervention. Further, a remote neuropsychological testing procedure will be developed and implemented and analogous questions will be asked around this procedure.
详细描述
Purpose
There would be strong value in developing a brief, manualized, remotely delivered, intervention capable of simultaneously improving both emotional well being and cognitive functioning in survivors of malignant brain tumour. The proposed study is designed to test the acceptability, feasibility, apparent efficacy, and areas for improvement of a newly developed intervention designed for this purpose. This investigation is being undertaken as a step toward conducting an randomized clinical trial.
Research Questions
As a feasibility study there will be no hypotheses tested in this study. Instead, the research will be conducted in order to answer the following four questions about the intervention:
- How acceptable was the intervention?
- How feasible was the intervention?
- How much apparent efficacy did the intervention have?
- How could the involved processes be improved?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a WHO grade 3 or 4 brain tumour
- •be under the care of a BC Cancer Agency (BCCA) centre for their brain tumour
- •have a Karnofsky Performance Score of 70 or more
- •be capable of offering informed consent
- •have a high speed internet connection in the home
排除标准
- •experiencing levels of distress that will make participation untenable and/or likely counter-productive
- •currently experiencing suicidal ideation
- •not be capable of speaking English at level such that a translator will be needed to obtain informed consent and/or for the participant to engage appropriately in the intervention/assessments
结局指标
主要结局
Change from baseline in score on Quality of Life score on the Functional Assessment of Cancer Therapy-Brain
时间窗: Comparison of scores pre-intervention to immediately post intervention (10 weeks) and 4 month followup
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a self report measure designed to assess quality of life in people living with brain malignancy across five dimensions: physical well-being, social/family well-being, emotional well being, functional well-being, and disease specific challenges.
次要结局
- Changes in scores regarding psychological distress(anxiety, depression and somatization) on the Brief Symptom Inventory -18(Comparison of scores pre-intervention to immediately post intervention (10 weeks) and 4 month followup)