Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT04929899

Conditions

Acute Lymphoblastic Leukemia (ALL)

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

Interventions

Bright Ideas - CIN Training

Study Details

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.

Conditions

Acute Lymphoblastic Leukemia (ALL)

Study ID

NCT04929899

Start date

Mar 1, 2022

Status verified date

Jan, 2025

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Bright Ideas- CIN Training

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.

Interventions

Bright Ideas - CIN Training

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

Primary outcome measure

  • Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months [ Time Frame: 24 months from study activation ]

Central Contacts and Locations

Central contacts

Lee Dupuis, PhD

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

Tadi Hondonga

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

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Lauren Guidry

lguidry@chla.usc.edu

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Katie Devine, PhD

katie.devine@rutgers.edu

Inova Children's Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Robin Dulman

rdulman@psvcare.org

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Lee Dupuis, PhD

416-813-7654lee.dupuis@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Jan 31, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-01-31.