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NCT06074666 | RECRUITING | Acute Lymphoblastic Leukemia, Pediatric

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

Roswell Park Cancer Institute

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.

Condition or disease

Acute Lymphoblastic Leukemia, Pediatric

Intervention/treatment

CareMeds Intervention

Usual Care Group

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2027-10-01
Estimated Study Completion Date : 2027-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years to 9 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

Location Details

NCT06074666

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14263