NCT04929899

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

3.3 years

First QC Date

June 8, 2021

Last Update Submit

January 28, 2025

Conditions

Acute Lymphoblastic Leukemia (ALL)

Outcome Measures

Primary Outcomes (1)

  • Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months

    A future trial will be feasible if * 50% of patients deemed to be eligible to participate in Phase 1 consent/assent to participate * the recruitment into Phase 2 of 20 evaluable patients across all participating centers within 24 months of study activation of whom 80% return a completed CINV diary for at least 5 days of each 7-day data collection period. A completed CINV diary contains at least one PeNAT score and a record of the time of each vomiting episode or noting the presence/absence of vomiting daily. Evaluable patients are defined as those who have completed at least one cycle of PSST.

    24 months from study activation

Secondary Outcomes (1)

  • CIN and CIV incidence

    24 months from study activation

Study Arms (1)

Bright Ideas- CIN Training

OTHER

The PSST will be delivered by a "trainer" in a minimum of three 30-minute to 1-hour sessions with a parent and patient (if developmentally appropriate). During the first session, the study team member will build rapport by understanding relevant personal background and medical information; introduce PSST and the Bright IDEAS paradigm; review the patients experience with nausea as reported in Phase 1 and at other times during treatment; promote problem-solving strategies and skills; and develop an anti-nausea action plan. During the second session, the trainer will discuss how well the prior action plan worked and reinforce successful outcomes or, if unsuccessful, return to the problem-solving steps to generate a new action plan. The third session will review progress on CINV control, assist in problem-solving as needed, and discuss how to continue to use the Bright IDEAS framework to resolve future issues with CINV or symptom management more broadly.

Behavioral: Bright Ideas - CIN Training

Interventions

Bright Ideas - CIN TrainingBEHAVIORAL

Bright IDEAS is a validated problem-solving skill training intervention.

Bright Ideas- CIN Training

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
  • newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
  • English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
  • without physical or cognitive impairments that preclude use of the PeNAT
  • planned to receive PO 6-mercaptopurine
  • not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

Inova Children's Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Lee Dupuis, PhD

    SickKids Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Dupuis, PhD

CONTACT

416-813-7762lee.dupuis@sickkids.ca

Tadi Hondonga

CONTACT

416-813-7654Tadi.hondonga@sickkids.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Scientist

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 18, 2021

Study Start

March 1, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(3)