Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

Official title:

Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074666
• Other study ID #: I 3774823
• Secondary ID: R01CA258337
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: Elizabeth Bouchard, PhD
• Phone: 716-845-1300
• Email: Elizabeth.Bouchard[@]roswellpark.rog
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.

Description:

This is a pilot randomized controlled trial of the CareMeds program to assess feasibility and obtain preliminary efficacy data among families of young children (ages 3-9) with ALL. The objective of this aim is to implement our study procedures and study conditions (CareMeds vs. usual care control). We hypothesize that pilot findings will support the feasibility of the intervention and suggest important improvements in our behavioral secondary outcomes (i.e., behavioral parenting skills, medication adherence

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

Inclusion Criteria:

• Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
• Parent has primary medication responsibility.
• Pediatric patient aged 3-9 years
• Child on therapy that includes home-based oral anti-cancer medication taken at home, such as 6-MP.
• Parent has verbal English or Spanish fluency.
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Parent of a child who is not diagnosed nor being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
• Parent does not have primary medication responsibility.
• Pediatric patient aged 3-9 years
• Pediatric patient is not on therapy that includes oral anti-cancer medication (e.g., 6-MP).
• Parent does not have verbal English or Spanish fluency.
• Parent is unwilling or unable to follow protocol requirements

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• CareMeds Intervention
3 parenting sessions will be offered during weeks 2 through 4 of the study period.
• Usual Care Group
3 parenting sessions will be offered during weeks 13 through 15 of the study period.

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the CareMeds 3 sessions	enrollment rates will be measured by number of consents . Reasons for refusal will also be captured	up to 3 years
Secondary	Behavioral Parenting skills	Self reported measure to assess the frequency of parental engagement on a scale from 1 (not at all) to 7 (Most of the time)	Weeks 1, 4 and 12.
Secondary	Oral Chemotherapy adherence	Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed.	UP to week 12