Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients
A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer
2 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2019
CompletedFirst Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2020
CompletedSeptember 16, 2021
September 1, 2021
1.9 years
March 28, 2019
September 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Objective medication adherence
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).
Up to 4 weeks post study
Secondary Outcomes (3)
Change in parenting stress
Baseline up to 4 weeks post study
Intervention feasibility
Up to 4 weeks post study
Change in parenting behaviors
Baseline up to 4 weeks
Study Arms (3)
Delayed Group (delayed parental skills)
EXPERIMENTALParticipants 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.
Early Group (early parental skills)
EXPERIMENTALParticipants 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.
Late Group (late parental skills)
EXPERIMENTALParticipants 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
Undergo parenting skills intervention
Undergo medication adherence monitoring
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Bouchard
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
March 29, 2019
Study Start
January 3, 2019
Primary Completion
November 25, 2020
Study Completion
November 25, 2020
Last Updated
September 16, 2021
Record last verified: 2021-09