Back to resultsBehavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Primary Purpose
Acute Lymphoblastic Leukemia, Pediatric
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CareMeds Intervention
Usual Care Group
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Lymphoblastic Leukemia, Pediatric
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CareMeds Intervention
Usual Care
Arm Description
Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.
Usual care consists of medical consultations and supportive care, The usual care group will serve as a delayed intervention/wait list group for which 3 parent training sessions will be offered during weeks 13 through 15.
Outcomes
Primary Outcome Measures
Feasibility of the CareMeds 3 sessions
enrollment rates will be measured by number of consents . Reasons for refusal will also be captured
Secondary Outcome Measures
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)
Oral Chemotherapy adherence
Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed.
Full Information
NCT ID
NCT06074666
First Posted
October 3, 2023
Last Updated
October 12, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT06074666
Brief Title
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Official Title
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Pediatric
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CareMeds Intervention
Arm Type
Experimental
Arm Description
Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care consists of medical consultations and supportive care, The usual care group will serve as a delayed intervention/wait list group for which 3 parent training sessions will be offered during weeks 13 through 15.
Intervention Type
Behavioral
Intervention Name(s)
CareMeds Intervention
Intervention Description
3 parenting sessions will be offered during weeks 2 through 4 of the study period.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Group
Intervention Description
3 parenting sessions will be offered during weeks 13 through 15 of the study period.
Primary Outcome Measure Information:
Title
Feasibility of the CareMeds 3 sessions
Description
enrollment rates will be measured by number of consents . Reasons for refusal will also be captured
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Behavioral Parenting skills
Description
Self reported measure to assess the frequency of parental engagement on a scale from 1 (not at all) to 7 (Most of the time)
Time Frame
Weeks 1, 4 and 12.
Title
Oral Chemotherapy adherence
Description
Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed.
Time Frame
UP to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Bouchard, PhD
Phone
716-845-1300
Ext
8357
Email
Elizabeth.Bouchard@roswellpark.rog
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Bouchard, PhD
Organizational Affiliation
Roswell Park Comprehensive Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
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