Official Title
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
Summary:
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 tumours 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.
Trial Description
Primary Outcome:
- Health-related quality of life (HRQOL) for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour
Secondary Outcome:
- HRQOL disease specific modules and family impact
- Symptom burden for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour
- Caregiver HRQOL
- Anxiety, Depression and Pain Interference
- Radiation necrosis (RN), local control, progression-free survival and overall survival after re-irradiation.
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
tumour (+/- 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.
Necrosis and local tumour control will be assessed using MRI ordered as part of
standard-of-care follow-up (recommended scan interval every 3-6 months until 5 years
post-treatment). Necrosis and other toxicities, if present without evidence of disease
recurrence, will be graded at baseline and each post-RT2 standard-of-care visit using CTCAE
v5.0 (a rating scale of side effects). Steroid use and Lansky play score will be recorded at
each visit. Progression and death will be collected from the health record. Re-irradiation
dosimetry (in electronic RT-DICOM format) will be requested for all enrolled patients.
Study measures will be available in both English and French. HRQOL measures will include: the
Pediatric Quality of Life (PedsQL) General module; the PedsQL Brain Tumour module; the PedsQL
Family Impact module; and the Short Form 36 (SF-36), to assess parent quality of life via
physical and mental health functioning subscales. Children who require help completing
questionnaires will be aided by a CRA. For those 2 to 5 years of age or those who have
cognitive disability that impairs their ability to self-report as assessed by their parents,
proxy-report by parent or caregiver will be used.
The Symptom Screening in Pediatrics Tool (SSPedi) will also be used to screen for pediatric
cancer symptoms.
The Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety, Depressive
Symptoms, and Pain Interference measures short forms will be administered to screen for
current symptoms of anxiety, depression and assess pain interference.
A linear mixed models approach will be used to compare HRQOL outcomes over time. Further,
HRQOL outcomes will be compared across assessment time points and paired sample t-tests will
be conducted to identify critical periods of significantly lower and/or higher HRQOL for
patients and caregivers. Correlational analyses will be used to explore variables that might
emerge as related to HRQL outcome scores. Recruitment rates (patients participating vs.
patients eligible) and retention rates (non-completion, lost to follow-up) will be examined.
Finally, all incident cases of radiation necrosis without obvious tumour progression will be
examined, while accounting for competing risks of disease progression and death from any
cause.
View this trial on ClinicalTrials.gov
