Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients

Malignant Neoplasm Clinical Trial

Official title:

A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895918
• Other study ID #: I 77618
• Secondary ID: NCI-2019-01554I
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: November 25, 2020

Study information

• Verified date: September 2021
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Guardian
• Hematologic and Lymphocytic Disorder
• Hematologic Diseases
• Malignant Neoplasm
• Neoplasms
• Parent

Intervention

Other:
• Educational Activity
Undergo parenting skills intervention

Procedure:
• Patient Monitoring
Undergo medication adherence monitoring

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in parenting stress	Pre and post intervention 15minute surveys	Baseline up to 4 weeks post study
Secondary	Intervention feasibility	Assessed using survey assessments	Up to 4 weeks post study
Secondary	Change in parenting behaviors	Pre and Post intervention 15 minute surveys	Baseline up to 4 weeks