Guardian, Hematologic and Lymphocytic Disorder, Malignant Neoplasm, Parent
Conditions
Brief summary
This trial studies how well a parenting skills intervention works in improving medication adherence in pediatric cancer patients. The parenting skills intervention provides support and skills training to parents who administer medicine daily to their child and may improve the childs taking of medications correctly as prescribed by the doctor. Ultimately, this may improve treatment outcomes, among children who are experiencing an illness.
Detailed description
PRIMARY OBJECTIVES: I. To pilot test a novel parenting intervention. II. To examine the feasibility and preliminary efficacy of the parenting intervention on child medication adherence among children who are experiencing an illness. OUTLINE: Participants with poor medication adherence are randomized to 1 of 3 groups. EARLY GROUP: Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks. DELAYED GROUP: Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks. LATE GROUP: Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
Interventions
OTHEREducational Activity
Undergo parenting skills intervention
PROCEDUREPatient Monitoring
Undergo medication adherence monitoring
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be a parent of a child (2 to 10 years old) with any hematology or oncology diagnosis who is receiving treatment at Roswell Park Comprehensive Cancer Center. We define parents as biological parents, adoptive parents, foster parents, stepparents, and legal guardians * Parent must have primary medication responsibility * The child's treatment must include home-based daily oral medication * Parent must have verbal English fluency * Participant or legal representative 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
* Be a parent of a pediatric patient with any hematology or oncology diagnosis who is receiving treatment at Roswell Park and is \< 2 or \> 10 years old * Parent does not have primary medication responsibility * Child's treatment does not include home-based daily oral medication * Parent does not have verbal English fluency * If unable to consent or a prisoner * Unwilling or unable to follow protocol requirements * Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective medication adherence | Up to 4 weeks post study | Assessed using Medication Event Monitoring Systems (MEMS) track caps.The project manager will conduct reviews of each child?s medical record to obtain data on the medication dose prescribed each day and dates when the medication was held for illness or toxicity. MEMS-based adherence variables will be constructed as a percentage based upon the ratio of the number of days with MEMS cap openings (X) to the number of days the medication was prescribed (N). Will remove days when the medication was held by the prescriber from the denominator (X/N x 100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in parenting stress | Baseline up to 4 weeks post study | Pre and post intervention 15minute surveys |
| Intervention feasibility | Up to 4 weeks post study | Assessed using survey assessments |
| Change in parenting behaviors | Baseline up to 4 weeks | Pre and Post intervention 15 minute surveys |
Countries
United States
Outcome results
None listed