Pediatric Cancer Clinical Trial
— EASEOfficial title:
Emotion and Symptom-Focused Engagement (EASE) for Caregivers: A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Parents of Children With Cancer
The goal of this two-site phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is: - Does EASE reduce traumatic stress symptom severity (primary outcome)? To do so, researchers will compare parents receiving EASE to usual care. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience.
Status | Not yet recruiting |
Enrollment | 306 |
Est. completion date | October 1, 2028 |
Est. primary completion date | October 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Self-identified primary parental family caregiver/guardian (i.e., parent assuming the majority of care activities) of a child: i) diagnosed with a new or relapsed life-threatening cancer within the preceding six months (disease-type eligibility per the Pediatric Oncology Group of Ontario Networked Information System); ii) <18 years of age; and, iii) receiving active cancer therapy; - Age =18 years; and, - Able to complete outcome measures and engage in EASE in English, which need not be their first language. Exclusion Criteria: - Impairment in cognitive functioning or communication that would preclude participation in EASE sessions or outcome measure completion, as determined by the research team; - Receiving formal ongoing psychotherapy at the time of recruitment; - Active suicidal intention, based on an item in the Distress Assessment and Response Tool (DART) that has been widely used in suicidal intention screening in cancer; or, - Child not expected to survive past the duration of trial, as determined by the child's medical team. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Traditional Masculinity-Femininity Scale [TMF] | This will be used to assess gender role. | Baseline | |
Other | Caregiver Reaction Assessment Scale [CRA] | This will be used to measure caregiver burden. | 6-months | |
Other | ENRICHD Social Support Instrument [ESSI] | This will be used to measure perceived social support. | 6-months | |
Other | Experiences in Close Relationships Scale [ECR-16] | This will be used to measure attachment security. | 6-months | |
Other | Hope of Improvement subscale of the Therapy Expectation and Evaluation Scale [PATHEVH] | This will be used to assess expectation of EASE effectiveness in the treatment arm. | Baseline | |
Primary | Posttraumatic Stress Disorder Checklist for DSM-5 [PCL-5] | This will be used to measure traumatic stress symptoms. | 6-months | |
Secondary | SF-36v2 Health Survey | This will be used to measure quality of life. | 6-months | |
Secondary | Patient Health Questionnaire [PHQ-9] | This will be used to measure depressive symptoms. | 6-months | |
Secondary | Caregiving Health Engagement Scale [CHE-s] | This will be used to measure parent capacity to care for their child. | 6-months | |
Secondary | Family Adaptability and Cohesion Evaluation Scales III [FACES-III] | This will be used to measure parent perceived family functioning. | 6-months | |
Secondary | Clinical Evaluation Questionnaire [CEQ] | This will be used to measure parent perceived benefit from interaction with clinicians. | 6-months | |
Secondary | Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10] | This will be used to measure parent satisfaction with care. | 6-months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Not yet recruiting |
NCT06335745 -
PediCARE Health Equity Intervention in High-Risk Neuroblastoma
|
N/A | |
Withdrawn |
NCT04719416 -
Relaxation Therapy in Pediatric Oncology
|
N/A | |
Completed |
NCT01645436 -
Physical Activity in Pediatric Cancer (PAPEC)
|
N/A | |
Completed |
NCT04409301 -
Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation
|
N/A | |
Completed |
NCT04914702 -
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
|
||
Recruiting |
NCT05425043 -
Granulocyte Transfusions After Umbilical Cord Blood Transplant
|
N/A | |
Recruiting |
NCT05071859 -
Genetic Overlap Between Anomalies and Cancer in Kids in the Children's Oncology Group: The COG GOBACK Study
|
||
Recruiting |
NCT03241251 -
Screening for Psychosocial Risk in Flemish Families of a Child With Cancer
|
||
Recruiting |
NCT05384288 -
Response to Influenza Vaccination in Pediatric Oncology Patients
|
||
Completed |
NCT04586491 -
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
|
N/A | |
Recruiting |
NCT05569512 -
Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT05294380 -
Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients
|
||
Completed |
NCT02665819 -
Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility.
|
N/A | |
Completed |
NCT02675166 -
Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
|
||
Not yet recruiting |
NCT05454163 -
Post-radiotherapy Rhinosinusitis in Children
|
||
Terminated |
NCT02536183 -
A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors
|
Phase 1 | |
Withdrawn |
NCT01828502 -
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
|
Phase 2 | |
Completed |
NCT02032121 -
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
|
N/A | |
Completed |
NCT03964259 -
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
|
Phase 1 |