Bright Ideas - CIN Feasibility Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
The Hospital for Sick Children
Study ID
NCT04929899
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia (ALL)

Eligibility Criteria

Sex
ALL
Age
4 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Bright Ideas - CIN Training — BEHAVIORAL
    Bright IDEAS is a validated problem-solving skill training intervention.

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Lauren Guidry
[email protected]
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Katie Devine, PhD
[email protected]
Inova Children's HospitalFalls ChurchVirginia22042
Robin Dulman
[email protected]

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Children's Hospital Los Angeles· Los Angeles, CARutgers Cancer Institute· New Brunswick, NJInova Children's Hospital· Falls Church, VA

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