Acute Lymphoblastic Leukemia, Pediatric
Conditions
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
Interventions
BEHAVIORALCareMeds Intervention
3 parenting sessions will be offered during weeks 2 through 4 of the study period.
BEHAVIORALUsual Care Group
3 parenting sessions will be offered during weeks 13 through 15 of the study period.
Sponsors
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No
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, 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 is unwilling or unable to follow protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the CareMeds 3 sessions | up to 3 years | enrollment rates will be measured by number of consents . Reasons for refusal will also be captured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Parenting skills | Weeks 1, 4 and 12. | 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 | UP to week 12 | Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed. |
Countries
United States
Contacts
CONTACTElizabeth Bouchard, PhD
PRINCIPAL_INVESTIGATORElizabeth Bouchard, PhD
Roswell Park Comprehensive Cancer Center
Outcome results
None listed