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

NCT04670016 | Completed

• 1 other identifier: HREBA.CC-16-0821
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 13

Brief 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 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.

Conditions

DIPG; Brain Tumor, Pediatric, Recurrent; Brain Tumor, DIPG; Radiation Toxicity; Radiation Exposure; Brain Tumor, Pediatric

Keywords

health-related quality of life; psychosocial; re-irradiation; DIPG; pediatric brain tumor

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (HRQOL) for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour

  Health-related quality-of-life will be measured using the Pediatric Quality of Life Inventory (PedsQL) General Core Scales

  2 months after the second radiation

Secondary Outcomes (5)

• 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]

• Anxiety, Depression and Pain Interference

  2 months after the second radiation]

• Radiation necrosis (RN), local control, progression-free survival and overall survival after re-irradiation.

  12 months

Other Outcomes (1)

• Feasibility of conducting routine assessment of HRQOL in children diagnosed with DIPG/recurrent brain tumours and their caregivers.

  4 months after the second radiation

Study Arms (2)

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

Other: 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

Other: This study does not include an intervention.

Interventions

This study does not include an intervention. OTHER

This study does not include an intervention.

Patient/Caregiver dyad diagnosed with DIPG; Patient/Caregiver dyad with re-RT for a recurrent brain tumour

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Up to 30 patients diagnosed with DIPG and up to 32 patients diagnosed with another recurrent or progressive brain tumor will be enrolled in this study. There will be no registration on study for screening purposes only. Eligible patients who consent to this study therapy will be registered at the PI's institution, specifically with the PI's research coordinator. A study subject number will be assigned to the patient upon registration.

You may qualify if:

• 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 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

You may not qualify if:

• \. Inability to complete questionnaires in English or French.

Sponsors & Collaborators

• University of Calgary: lead
• University of Toronto: collaborator
• Université de Montréal: collaborator
• University of Ottawa: collaborator
• Western University, Canada: collaborator
• McMaster University: collaborator
• Alberta Children's Hospital: collaborator
• Stollery Children's Hospital: collaborator
• British Columbia Children's Hospital: collaborator
• CancerCare Manitoba: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• The Hospital for Sick Children: collaborator
• McMaster Children's Hospital: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• St. Justine's Hospital: collaborator
• Montreal Children's Hospital of the MUHC: collaborator
• IWK Health Centre: collaborator
• Janeway Children's Health and Rehabilitation Centre: collaborator
• Princess Margaret Hospital, Canada: collaborator
• London Health Sciences Centre: collaborator
• The Ottawa Hospital: collaborator
• CHU de Quebec-Universite Laval: collaborator

Study Sites (13)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital

London, Ontario, N6A 5W9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H3T 1C5, Canada

Location

CHU de Quebec-Universite Laval

Québec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms; Recurrence; Diffuse Intrinsic Pontine Glioma; Radiation Injuries

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Wounds and Injuries

Study Officials

• Fiona Schulte, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Derek Tsang, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ssistant Professor in the Department of Oncology, Division of Psychosocial Oncology in the Cumming School of Medicine

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 17, 2020
• Study Start: July 2, 2020
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)