Clinical Trials Logo

Clinical Trial Summary

In this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with ALL receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. This is a novel approach to controlling an important and common treatment-related symptom.


Clinical Trial Description

This study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. It will preserve and enhance the patient's and family's autonomy with respect to self-care. If found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy. This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children with ALL who experience nausea while receiving 6-mercaptopurine. Bright IDEAS is an 8-session face-to-face intervention with a caregiver. In this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. Sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. The final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. Investigators adapted Bright IDEAS to meet the specific problem of CINV by adapting it to 3 sessions focused specifically on CINV, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat. ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia (ALL)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

NCT number NCT04929899
Study type Interventional
Source The Hospital for Sick Children
Contact Lee Dupuis, PhD
Phone 416-813-7654
Email lee.dupuis@sickkids.ca
Status Recruiting
Phase N/A
Start date March 1, 2022
Completion date June 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03590171 - International Study for Treatment of High Risk Childhood Relapsed ALL 2010 Phase 2
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Recruiting NCT01351545 - A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Recruiting NCT02894645 - Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study Phase 4
Completed NCT03236857 - A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies Phase 1
Completed NCT03181126 - A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma Phase 1
Recruiting NCT05291390 - Pyronaridine in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01282593 - Potential Role of CD9 and Implication of Motility Process in Pathogenesis of TEL/ALM1-positive ALL Relapses (LAL TEL/ALM1 and CD9). N/A
Completed NCT01221857 - Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies Phase 1/Phase 2
Completed NCT01885897 - IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT Phase 1/Phase 2
Completed NCT03067584 - Genetic Study of Familial Acute Lymphoblastic Leukemia
Recruiting NCT05884333 - Cord Blood Transplant in Adults With Blood Cancers Phase 2
Terminated NCT02338050 - Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT01802814 - International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 Phase 3
Completed NCT00495079 - Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia Phase 2
Completed NCT01735955 - Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study Phase 4
Terminated NCT01439347 - A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL Phase 3
Active, not recruiting NCT02061800 - CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant Phase 1/Phase 2
Terminated NCT01050764 - Haploidentical Allogeneic Transplant With Post-transplant Infusion of Regulatory T-cells Phase 1/Phase 2