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60 active trials for Pediatric Cancer

Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood

The participants are being asked to take part in this research study because the participant is a child who has been diagnosed with cancer and has completed genetic testing to find out if the participant has a variant in a gene that may predispose the participant to cancer, and/or the participants are the parents (i.e., guardian/caregiver) of this child. This research is being done to understand how finding out the results of genetic testing during childhood impacts the participant and family. The investigator will compare the emotions and behavior of parents and children based on the genetic testing results. Primary Objective Examine the impact of genetic testing result disclosure for a pathogenic (P)/likely pathogenic (LP) germline variant in a known cancer predisposing gene versus negative results on parent adjustment (i.e., emotional functioning, cancer worry, symptom interpretation, and genetic testing related worry/distress). Examine the impact of genetic testing result disclosure for a P/LP germline variant versus negative results on parenting (i.e., responses to children's symptoms, overprotectiveness, parent-child communication, cohesion, and expressivity in the family). Exploratory Objectives Examine the impact of genetic testing result disclosure (P/LP versus negative results) on child adjustment (i.e. emotional functioning, cancer worry, self-perception, and life meaning and purpose). Examine the impact of disclosing a variant of uncertain significance (VUS) on parent adjustment, parenting, and child adjustment. Examine the indirect association between genetic testing result disclosure (P/LP versus negative results) and child adjustment through parental adjustment and parenting behavior. Qualitatively identify children and parents' perspectives of how disclosure of a cancer predisposition has affected children's emotional, social, personal, and familial functioning.

Start: May 2021

Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma

This is a 2 strata pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC). The study will use a new treatment approach based on each patient's tumor gene expression, whole-exome sequencing (WES), targeted panel profile (UCSF 500 gene panel), and RNA-Seq. The current study will test the efficacy of such an approach in children with High-grade gliomas HGG.

Start: November 2018

Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment

Music therapy has become a standard palliative care service in many pediatric and adult hospitals; however, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work examining the psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents, by examining its effects on biomarkers of stress and immune function. The purposes of this two group, randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute Lymphoblastic Leukemia (ALL) treatment. Specific aims are to: Aim 1. Establish whether AME lowers child and parent cortisol during ALL treatment. Aim 2. Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL treatment. Aim 3 (exploratory). Examine the dose-response relationship of AME on child and parent cortisol during ALL treatment. Findings will provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function, with direct implications for the evidence-based use of music to improve health.

Start: August 2020

Survivor-Sleep Health Information Program

The purpose of the study is to learn if an educational program delivered to parents/guardians can help improve the sleep of children experiencing sleep problems after completing cancer treatment. The name of the intervention is Survivor-SHIP (Sleep Health Information Program).

Start: June 2021

SibACCESS: Developing a Telehealth Intervention to Address Unmet Psychosocial Needs of Siblings of Children With Cancer

This study aims to address barriers to psychosocial care for siblings of children with cancer by piloting a group-based telehealth program for adolescent siblings of youth with cancer. The pilot trial will be preceded by a treatment development stage during which study staff will interview English- and Spanish-speaking families and psychosocial providers to assess preferences for program content, format, timing, and cultural feasibility and acceptability, while considering ideas to minimize participation barriers. Information from interviews will inform any revisions to the proposed pilot program. Then, the new SibACCESS program will be tested with a small group of families located in Massachusetts or Rhode Island using video-teleconferencing technology. Families will complete exit interviews to assess program acceptability and perceived benefits.

Start: April 2022

Understanding the Late Effects of Surviving a Pediatric Brain Tumor

The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.

Start: June 2017

ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs

The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 Italian PICUs.

Start: March 2021

Phase I Study of Marizomib + Panobinostat for Children With DIPG

This research study is evaluating the safety, tolerability and preliminary efficacy of the drugs marizomib and panobinostat in pediatric patients with diffuse intrinsic pontine glioma (DIPG). The names of the study drugs involved in this study are: Marizomib Panobinostat

Start: August 2020

Education Tools to Support Pediatric Survivor Care

This study aims to evaluate the impact of electronic educational materials on adolescent and young adult ("AYA") survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.

Start: June 2021

Memory Neuroimaging in Children, Adolescents and Young Adults Following Pediatric Cancer

Brain tumours are the leading cause of cancer-related death and morbidity in children, adolescents and young adults. The brain is also one of the most sensitive organs to treatments used in pediatric oncology, even for cancers not related to the central nervous system. Therapeutic index is therefore a major issue in pediatric neuro-oncology. The efficacy of the therapy as well as its toxicity are difficult to measure using standard tests. In order to optimize therapies that could have an impact on the brain, and consequently on the quality of life of patients, it becomes crucial to optimize the means of evaluation. Few studies to date have focused on the various components of memory impacted following treatment of a posterior fossa tumour. However, supra-tentorial structures such as the hippocampus, which have long been described for their role in memory, are either partially irradiated (irradiated in their lower part due to their proximity to the target volume during irradiation of the posterior fossa) or completely irradiated (e.g. included in the prophylactic irradiation of medulloblastoma prior to dose supplementation in the posterior fossa). On the other hand, the cerebellum plays a central role in learning and procedural memory involved in motor and cognitive learning, as it enables automation and procedural retention such as reading (automation of the grapho-phonemic conversion procedure) or arithmetic (mental arithmetic). IMPALA study is aimed at investigating the impact of different irradiation doses received by children treated with radiotherapy on cognitive functions related to the hippocampus and to the cerebellum. This exploratory study will thus provide elements enabling a better limitation of radiotherapy doses on regions linked to the development of cognition and memory. The project brings together researchers and clinicians with complementary expertise in oncology, neurology and imaging in both children and adults. This study will also provide a better understanding of the role of the cerebellum in memory and executive functions, and develop a method that can then be used in a prospective longitudinal multicentre form.

Start: February 2020

Cancer Therapy Effects on the Heart

Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.

Start: September 2019

Childhood Cancer Predisposition Study (CCPS)

The Childhood Cancer Predisposition Study (CCPS) is a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a cancer predisposition syndromes (CPS) and their relatives. The central hypothesis is that studying individuals at high risk for childhood cancer creates a unique opportunity for improving the understanding of carcinogenesis, tumor surveillance, early detection, and cancer prevention, which will collectively contribute to improving care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS).

Start: April 2021

How Family Coping With Child Cancer Affects Child's Quality of Life?

Children with newly diagnosed cancer and their parents will be contacted and invited to participate. Upon agreement, children will be interviewed, both parents will fill out questionnaires and be additionally interviewed. Using a 3-wave longitudinal design, mainly self-reported parental we-appraisals and we-disease-appraisals, couple dyadic coping (DC) and parent-child DC during a course of 12 months will be examined. Additionally, during brief separate interviews, the parents' speech will be coded for we-appraisals and expressed emotion regarding the other partner and the child. Findings will provide information on how family variables affect child QoL over 12 months.

Start: June 2015

Pediatric Prospective Personalized Immune and Target Identification Trial

PPROSPERITIT is a prospective clinical study assessing the use of comprehensive molecular profiling to define the best matching targeted and immune treatment for relapsed, refractory or very high risk pediatric CNS tumors.

Start: February 2021

Nurse-Adolescent/Young Adult With Cancer Dyadic Storytelling Intervention

Purpose/Specific Aim: This study aims to test the feasibility, acceptability, and preliminary efficacy of a dyadic storytelling intervention to promote human flourishing in adolescents and young adults with cancer, as well as job satisfaction in nurses. Hypothesis: The nurse-adolescents/young adults with cancer dyadic storytelling intervention will achieve more than 80% of the following feasibility and acceptability benchmarks: recruitment rate, retention rate, intervention completion, perceived benefits, and participation satisfaction. Design: A single-group pretest-posttest clinical trial design with a total of 30 adolescents and young adults with cancer and their primary nurses will be employed. Each adolescent and young adult will be paired with a nurse and participate in an online storytelling intervention for five weeks.

Start: September 2021

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

This research study is examining a preventive skin care regimen for children diagnosed with a brain tumor and receiving anti-cancer therapy with a MEK, Pan-RAF, or BRAF inhibitor.

Start: October 2020

Feasibility Neurocognitive Outcome After Transplant

This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based neurocognitive intervention program. It will secondarily be evaluated by performance on the neurocognitive testing post-transplant and change in performance in subsequent years.

Start: December 2014

Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer

This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.

Start: June 2020

Relaxation Therapy in Pediatric Oncology

This study will look at the use of relaxation therapy in children with cancer. The study will compared patients who are current receiving treatment for their cancer and those who are currently in remission. Patients will be asked to listen to a short audio recording twice a week prior to going to bed which will walk patients through a mediation session. Surveys will be distributed through parental emails on the first of each month for each child to complete for the duration of 12 months. It is anticipated that the use of relaxation therapy will help to improve anxiety and pain levels in this population.

Start: May 2021

Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants

Pain is a vital sign that depends on personal experience involving different factors such as previous sensory and emotional experience, age, spiritual and cultural aspects, that makes it harder to evaluate, especially in young children. Pain control is important to diminish the anxiety of the child and family, also this is more important in patients who require procedure and treatment that are more painful, like oncological and hematological patients. The study aims to measure if the intranasal drugs (dexmedetomidine and fentanyl) has the same outcomes when compared with intravenous drug (ketamine and midazolam), but with less side effects. The participants are patients from an oncologic outpatient, that will be submitted to cerebrospinal fluid puncture, myelogram or both will be randomized assigned to both groups. The study will compare physiological variables ( heart rate, respiratory rate and blood pressure) and sedation and pain scales to see if its work properly. The study purpose is to evaluate if intranasal drug works in the same way with less side effects comparing with the usual treatment.

Start: June 2021