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

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ClinicalTrials.gov Identifier: NCT04670016
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
University of Toronto
Université de Montréal
University of Ottawa
University of Western Ontario, Canada
McMaster University
Alberta Children's Hospital
Stollery Children's Hospital
British Columbia Children's Hospital
CancerCare Manitoba
Children's Hospital of Eastern Ontario
The Hospital for Sick Children
McMaster Children's Hospital
Children's Hospital Medical Center, Cincinnati
St. Justine's Hospital
Montreal Children's Hospital of the MUHC
IWK Health Centre
Janeway Children's Health and Rehabilitation Centre
Princess Margaret Hospital, Canada
London Health Sciences Centre
The Ottawa Hospital
CHU de Quebec-Universite Laval
Information provided by (Responsible Party):
Fiona Simone Maria Schulte, University of Calgary

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.


Condition or disease Intervention/treatment
DIPG Brain Tumor, Pediatric, Recurrent Brain Tumor, DIPG Radiation Toxicity Radiation Exposure Brain Tumor, Pediatric Other: This study does not include an intervention.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Group/Cohort Intervention/treatment
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.
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.
This study does not include an intervention.




Primary Outcome Measures :
  1. Health-related quality of life (HRQOL) for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour [ Time Frame: 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


Secondary Outcome Measures :
  1. HRQOL disease specific modules and family impact [ Time Frame: 2 months after the second radiation] ]
    PedsQL Brain Tumor and Family Impact Module

  2. Symptom burden for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour [ Time Frame: 2 months after the second radiation] ]
    Symptom Screening in Pediatrics (SSPEDI)

  3. Caregiver HRQOL [ Time Frame: 2 months after the second radiation] ]
    Short Form 36 (SF-36)

  4. Anxiety, Depression and Pain Interference [ Time Frame: 2 months after the second radiation] ]
    Patient Reported Outcomes Measurement Information System (PROMIS): Anxiety, Depression and Pain Interference Short Forms

  5. Radiation necrosis (RN), local control, progression-free survival and overall survival after re-irradiation. [ Time Frame: 12 months ]
    Radiation necrosis without obvious tumour progression


Other Outcome Measures:
  1. Feasibility of conducting routine assessment of HRQOL in children diagnosed with DIPG/recurrent brain tumours and their caregivers. [ Time Frame: 4 months after the second radiation ]
    Recruitment (patients participating vs. patients eligible) and retention rates



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  1. Patient aged >2 and <21 years treated with a repeat course of radiation for DIPG or other recurrent or progressive brain tumour.
  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:

1. Inability to complete questionnaires in English or French.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04670016


Contacts
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Contact: Caitlin Forbes 403-955-7831 caitlin.forbes@ucalgary.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Caitlin Forbes    403-955-7831    caitlin.forbes@albertahealthservices.ca   
Principal Investigator: Fiona Schulte, PhD         
Principal Investigator: Douglas Strother, MD         
Stollery Children's Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: David Eisenstat, MD       eisensta@ualberta.ca   
Principal Investigator: David Eisenstat, MD         
Canada, British Columbia
British Columbia Children's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Juliette Hukin, MB       jhukin@cw.bc.ca   
Principal Investigator: Juliette Hukin, MB         
Principal Investigator: Karen Goddard, MD         
Canada, Manitoba
CancerCare Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Magimairajan Issai Vanan, MD       MagimairajanIssai.Vanan@cancercare.mb.ca   
Principal Investigator: Magimairajan Issai Vanan, MD         
Principal Investigator: Junliang Liu, MD         
Canada, Nova Scotia
IWK Health Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Craig Erker, MD       craig.erker@iwk.nshealth.ca   
Principal Investigator: Craig Erker, MD         
Canada, Ontario
McMaster Children's Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Adam Fleming, MD       afleming@mcmaster.ca   
Principal Investigator: Adam Fleming, MD         
Principal Investigator: Ian Hodson, MD         
Children's Hospital Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Shayna Zelcer, MD       shayna.zelcer@lhsc.on.ca   
Principal Investigator: Shayna Zelcer, MD         
Principal Investigator: Tracy Sexton, MD, PhD         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Glenn Bauman, MD       glenn.bauman@lhsc.on.ca   
Principal Investigator: Glenn Bauman, MD         
Children's Hospital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Donna Johnston, MD       djohnston@cheo.on.ca   
Principal Investigator: Donna Johnston, MD         
Principal Investigator: Asha Nair, MD         
Principal Investigator: Lynn Chang, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ute Bartels, MD, MSc       ute.bartels@sickkids.ca   
Principal Investigator: Ute Bartels, MD, MSc         
Principal Investigator: Eric Bouffet, MD         
Principal Investigator: Vijay Ramaswamy, MD, PhD         
Principal Investigator: Lillian Sung, MD, PhD         
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Derek Tsang, MD, MSc       derek.tsang@rmp.uhn.ca   
Principal Investigator: Derek Tsang, MD, MSc         
Principal Investigator: Amy Zhihui Liu, PhD         
Principal Investigator: David Hodgson, MD, MPH         
Principal Investigator: Normand Laperriere, MD         
Canada, Quebec
Centre hospitalier de l'Université de Montréal Not yet recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Anne-Marie Charpentier, MD       anne-marie.charpentier@umontreal.ca   
Principal Investigator: Anne-Marie Charpentier, MD         
Canada
CHU de Quebec-Universite Laval Not yet recruiting
Quebec, Canada, G1V 4G2
Contact: Valérie Larouche, MD       valerie.larouche@chudequebec.ca   
Principal Investigator: Valérie Larouche, MD         
Sponsors and Collaborators
University of Calgary
University of Toronto
Université de Montréal
University of Ottawa
University of Western Ontario, Canada
McMaster University
Alberta Children's Hospital
Stollery Children's Hospital
British Columbia Children's Hospital
CancerCare Manitoba
Children's Hospital of Eastern Ontario
The Hospital for Sick Children
McMaster Children's Hospital
Children's Hospital Medical Center, Cincinnati
St. Justine's Hospital
Montreal Children's Hospital of the MUHC
IWK Health Centre
Janeway Children's Health and Rehabilitation Centre
Princess Margaret Hospital, Canada
London Health Sciences Centre
The Ottawa Hospital
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: Fiona Schulte, PhD University of Calgary
Principal Investigator: Derek Tsang, MD Princess Margaret Cancer Centre
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Responsible Party: Fiona Simone Maria Schulte, ssistant Professor in the Department of Oncology, Division of Psychosocial Oncology in the Cumming School of Medicine, University of Calgary
ClinicalTrials.gov Identifier: NCT04670016    
Other Study ID Numbers: HREBA.CC-16-0821
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fiona Simone Maria Schulte, University of Calgary:
health-related quality of life
psychosocial
re-irradiation
DIPG
pediatric brain tumor
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Diffuse Intrinsic Pontine Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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