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Trial Title:
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
NCT ID:
NCT06074666
Condition:
Acute Lymphoblastic Leukemia, Pediatric
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CareMeds Intervention
Description:
3 parenting sessions will be offered during weeks 2 through 4 of the study period.
Arm group label:
CareMeds Intervention
Intervention type:
Behavioral
Intervention name:
Usual Care Group
Description:
3 parenting sessions will be offered during weeks 13 through 15 of the study period.
Arm group label:
Usual Care
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.
Detailed 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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
3 Years
Maximum age:
9 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Bouchard, MD
Phone:
716-845-8357
Email:
elizabeth.Bouchard@roswellpark.org
Start date:
December 1, 2024
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06074666
