Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm; Parent; Hematologic and Lymphocytic Disorder; Guardian
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Activity; Procedure: Patient Monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delayed Group (delayed parental skills); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Activity; Undergo parenting skills intervention; Procedure: Patient Monitoring; Undergo medication adherence monitoring; Other Names: monitor
Experimental: Early Group (early parental skills); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Activity; Undergo parenting skills intervention; Procedure: Patient Monitoring; Undergo medication adherence monitoring; Other Names: monitor
Experimental: Late Group (late parental skills); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Activity; Undergo parenting skills intervention; Procedure: Patient Monitoring; Undergo medication adherence monitoring; Other Names: monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parenting stress	Pre and post intervention 15minute surveys	Baseline up to 4 weeks post study
Intervention feasibility	Assessed using survey assessments	Up to 4 weeks post study
Change in parenting behaviors	Pre and Post intervention 15 minute surveys	Baseline up to 4 weeks

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Elizabeth Bouchard, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): November 25, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Hematologic Diseases
• Other Study ID Numbers: I 77618 (Other Identifier: Roswell Park Cancer Institute); NCI-2019-01554 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No