Health Related Quality of Life (HRQL) and Symptom Assessment in Patients Diagnosed With Diffuse Intrinsic Pontine Glioma (DIPG) or Recurrent and Re-irradiated Brain Tumours and Their Caregivers: A Non-Therapeutic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 15
- 主要终点
- Health-related quality of life (HRQOL) for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour
研究概览
简要总结
Although many children with brain tumours are successfully cured of their disease, a substantial proportion of patients suffer disease recurrence and require further treatment. This therapy may involve a repeat course of radiation (RT2). Based on retrospective data, re-irradiation may provide palliative and even potentially curative benefit. However, such retrospective data are subject to bias, which may over-report survival and under-report toxicity. Furthermore, we do not know how re-irradiation affects patients' HRQOL. The goal of this research is to prospectively describe the HRQOL of patients diagnosed with DIPG and recurrent brain tumors and their families before and after re-irradiation to more accurately assess the benefit versus the toxicity of this treatment.
In addition, if we are able to demonstrate the feasibility of collecting HRQOL information on a routine basis we will be able to justify the need to conduct this research further and implement HRQOL screening as a standard of care for these patients. Re-irradiation for children with DIPG and recurrent brain tumours will not cure these children from their disease but may improve neurological function and wellbeing. We postulate that the opportunity of more time to say the final good bye and creating memories will facilitate bereavement and prevent psychological dysfunction of parents and siblings. A greater understanding of what helps these families may enable clinicians to better support these children and their families in this difficult disease course. Ultimately our goal is to improve the psychological experience of these patients and their families.
详细描述
Many children diagnosed with brain tumours are at significant risk of disease recurrence following their initial treatment, with recurrence rates ranging from 30-100% depending on the type of brain tumour. Disease recurrence represents a serious clinical issue in brain tumour patients and when this occurs, additional treatment is needed. These treatments may result in further damage to the surrounding normal brain tissue, resulting in neurocognitive decline (brain or mental function) and reduced quality of life. A novel treatment option for these patients is to administer a second course of radiation (re-irradiation). However, the effects of re-irradiation on quality-of-life are poorly studied. This study aims to increase the knowledge surrounding re-irradiation, particularly with regards to HRQOL.
The primary objective of the proposed study is to describe the HRQOL and symptoms for children diagnosed with DIPG or recurrent brain tumours treated with repeat radiation and their caregivers over time.
We have four Aims. Aim 1: To describe the HRQOL trajectory and symptoms for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour and their caregivers over time. Aim 2: To identify critical time points of HRQOL difficulty across the trajectory of DIPG/recurrent brain tumour treatment and to ascertain demographic and/or medical sequelae that are related to HRQOL outcomes. Aim 3: To determine the feasibility of conducting routine assessment of HRQL in children diagnosed with DIPG/recurrent brain tumours and their caregivers based on recruitment and retention rates. Aim 4: To report the incidence of radiation necrosis (RN), local control, progression-free survival and overall survival after re-irradiation.
Our goal to is enroll 25 to 30 patient/caregiver dyads diagnosed with DIPG and 32 patient/caregiver dyads treated with re-RT for a recurrent/progressive brain tumour onto the trial over the study period and to follow patients until their disease progresses again, which has been, on average, 6 months after completion of RT2.
Once deemed eligible, individual patient recruitment will be the responsibility of the institution Clinical Research Assistant (CRA). Upon consenting to take part in the study, patients and families will be contacted using an online administration and scoring program. HRQOL assessments will take 15-25 minutes to complete at each time point. Baseline questionnaires will be completed at the time of recurrence or progressive DIPG or other brain tumor (+/- 7 days from start of treatment, maximum 14 days). Patients will then complete HRQOL measures at the end of re-irradiation and then again every two months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged >2 and <21 years treated with a repeat course of radiation for DIPG or other recurrent or progressive brain tumour.
- •Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia).
- •Enrollment within 14 days of starting re-irradiation (RT2).
- •Patients with malignant transformation of the first tumour are eligible.
- •There are no restrictions on histology or RT1/RT2 dose-fractionation or RT2 body site. In other words, RT2 may be directed at a different location to RT
- •The patient is treated at a site where the study is approved by the local ethics board
- •Consent, and, if applicable, assent, has been obtained according to institutional standards
排除标准
- •1. Inability to complete questionnaires in English or French.
研究组 & 干预措施
Patient/Caregiver dyad diagnosed with DIPG
All of these criteria must be met for a patient to be eligible for this study:
- Patient aged >2 and <21 years treated with a repeat course of radiation for DIPG
- Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia).
- Enrollment within 14 days of starting re-irradiation (RT2).
- Patients with malignant transformation of the first tumour are eligible.
- There are no restrictions on histology or RT1/RT2 dose-fractionation or RT2 body site. In other words, RT2 may be directed at a different location to RT1.
- The patient is treated at a site where the study is approved by the local ethics board
- Consent, and, if applicable, assent, has been obtained according to institutional standards
干预措施: This study does not include an intervention. (Other)
Patient/Caregiver dyad with re-RT for a recurrent brain tumour
All of these criteria must be met for a patient to be eligible for this study:
- Patient aged >2 and <21 years treated with a repeat course of radiation for a recurrent or progressive brain tumour (stratum 2).
- Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia).
- Enrollment within 14 days of starting re-irradiation (RT2).
- Patients with malignant transformation of the first tumour are eligible.
- There are no restrictions on histology or RT1/RT2 dose-fractionation or RT2 body site. In other words, RT2 may be directed at a different location to RT1.
- The patient is treated at a site where the study is approved by the local ethics board
- Consent, and, if applicable, assent, has been obtained according to institutional standards
干预措施: This study does not include an intervention. (Other)
结局指标
主要结局
Health-related quality of life (HRQOL) for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour
时间窗: 2 months after the second radiation
Health-related quality-of-life will be measured using the Pediatric Quality of Life Inventory (PedsQL) General Core Scales
次要结局
- Anxiety, Depression and Pain Interference(2 months after the second radiation])
- HRQOL disease specific modules and family impact(2 months after the second radiation])
- Symptom burden for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour(2 months after the second radiation])
- Caregiver HRQOL(2 months after the second radiation])
- Radiation necrosis (RN), local control, progression-free survival and overall survival after re-irradiation.(12 months)
研究者
Fiona Simone Maria Schulte
ssistant Professor in the Department of Oncology, Division of Psychosocial Oncology in the Cumming School of Medicine
University of Calgary