HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers
NCT ID: NCT04670016
Last Updated: 2022-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
57 participants
OBSERVATIONAL
2020-07-02
2023-12-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient/Caregiver dyad diagnosed with DIPG
All of these criteria must be met for a patient to be eligible for this study:
1. Patient aged \>2 and \<21 years treated with a repeat course of radiation for DIPG
2. Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia).
3. Enrollment within 14 days of starting re-irradiation (RT2).
4. Patients with malignant transformation of the first tumour are eligible.
5. 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.
6. The patient is treated at a site where the study is approved by the local ethics board
7. Consent, and, if applicable, assent, has been obtained according to institutional standards
This study does not include an intervention.
This study does not include an intervention.
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:
1. Patient aged \>2 and \<21 years treated with a repeat course of radiation for a recurrent or progressive brain tumour (stratum 2).
2. Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia).
3. Enrollment within 14 days of starting re-irradiation (RT2).
4. Patients with malignant transformation of the first tumour are eligible.
5. 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.
6. The patient is treated at a site where the study is approved by the local ethics board
7. Consent, and, if applicable, assent, has been obtained according to institutional standards
This study does not include an intervention.
This study does not include an intervention.
Interventions
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This study does not include an intervention.
This study does not include an intervention.
Eligibility Criteria
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Inclusion Criteria
2. Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia).
3. Enrollment within 14 days of starting re-irradiation (RT2).
4. Patients with malignant transformation of the first tumour are eligible.
5. 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.
6. The patient is treated at a site where the study is approved by the local ethics board
7. Consent, and, if applicable, assent, has been obtained according to institutional standards
Exclusion Criteria
2 Years
21 Years
ALL
No
Sponsors
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University of Toronto
OTHER
Université de Montréal
OTHER
University of Ottawa
OTHER
Western University, Canada
OTHER
McMaster University
OTHER
Alberta Children's Hospital
OTHER
Stollery Children's Hospital
OTHER
British Columbia Children's Hospital
OTHER
CancerCare Manitoba
OTHER
Children's Hospital of Eastern Ontario
OTHER
The Hospital for Sick Children
OTHER
McMaster Children's Hospital
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
St. Justine's Hospital
OTHER
Montreal Children's Hospital of the MUHC
OTHER
IWK Health Centre
OTHER
Janeway Children's Health and Rehabilitation Centre
UNKNOWN
Princess Margaret Hospital, Canada
OTHER
London Health Sciences Centre
OTHER
The Ottawa Hospital
OTHER
CHU de Quebec-Universite Laval
OTHER
University of Calgary
OTHER
Responsible Party
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Fiona Simone Maria Schulte
ssistant Professor in the Department of Oncology, Division of Psychosocial Oncology in the Cumming School of Medicine
Principal Investigators
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Fiona Schulte, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Derek Tsang, MD
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Locations
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Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital
London, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HREBA.CC-16-0821
Identifier Type: -
Identifier Source: org_study_id
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