HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers

Titre officiel

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

Sommaire:

Bien qu’on réussisse à guérir de nombreux enfants atteints de tumeurs cérébrales, une proportion importante de patients souffrent de récidive et nécessitent un traitement supplémentaire. Ce traitement peut comprendre une répétition de la radiothérapie (RT2). D’après des données rétrospectives, une seconde radiothérapie peut apporter un bienfait palliatif, et même potentiellement curatif. Toutefois, ces données rétrospectives peuvent faire l’objet de biais, ce qui peut entraîner une surdéclaration de la survie et une sous-déclaration de la toxicité. Par ailleurs, nous ne connaissons pas les effets d’une seconde radiothérapie sur la qualité de vie liée à la santé (QdVLS) des patients. L’objectif de cette étude est de décrire de manière prospective la QdVLS des patients ayant reçu un diagnostic de gliome diffus pontique intrinsèque (GDPI) et de tumeurs cérébrales récurrentes et de leurs familles avant et après une seconde radiothérapie afin d’évaluer avec davantage de précision les bienfaits par rapport à la toxicité de ce traitement. En outre, si nous pouvons montrer la faisabilité de la collecte systématique de données sur la QdVLS, nous serons en mesure de justifier la nécessité de poursuivre cette recherche et de mettre en œuvre le dépistage de la QdVLS comme norme de soins pour ces patients. Une seconde radiothérapie ne permettra pas de guérir les enfants atteints d’un GDPI et de tumeurs cérébrales récurrentes, mais pourrait améliorer leur fonction neurologique et leur bien-être. Nous formulons l’hypothèse selon laquelle la possibilité de disposer de plus de temps pour faire les adieux et créer des souvenirs facilitera le deuil et préviendra les troubles psychologiques chez les parents et les frères et sœurs. Une meilleure compréhension de ce qui aide les familles pourrait permettre aux cliniciens de mieux soutenir les enfants et leurs familles compte tenu de l’évolution difficile de la maladie. Au bout du compte, notre objectif consiste à améliorer l’expérience psychologique de ces patients et de leurs familles.

Description de l'essai

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.

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