RECRUITING

Bright Ideas - CIN Feasibility Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy

Quick Facts

Study Start:2022-03-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04929899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
  2. * newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
  3. * English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
  4. * without physical or cognitive impairments that preclude use of the PeNAT
  5. * planned to receive PO 6-mercaptopurine
  6. * not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lee Dupuis, PhD
CONTACT
416-813-7654
lee.dupuis@sickkids.ca
Tatiana Son
CONTACT
416-813-7654
Tatiana.son@sickkids.ca

Principal Investigator

Lee Dupuis, PhD
PRINCIPAL_INVESTIGATOR
SickKids Research Institute

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
United States
Inova Children's Hospital
Falls Church, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: The Hospital for Sick Children

  • Lee Dupuis, PhD, PRINCIPAL_INVESTIGATOR, SickKids Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia (ALL)