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Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03895918
Collaborator
(none)
9
Enrollment
1
Location
3
Arms
22.7
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Activity
  • Procedure: Patient Monitoring
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer
Actual Study Start Date :
Jan 3, 2019
Actual Primary Completion Date :
Nov 25, 2020
Actual Study Completion Date :
Nov 25, 2020

Arms and Interventions

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: Educational Activity
Undergo parenting skills intervention

Procedure: Patient Monitoring
Undergo medication adherence monitoring
Other Names:
  • monitor

    • Other: Questionnaire Administration
    Ancillary studies
    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: Educational Activity
    Undergo parenting skills intervention

    Procedure: Patient Monitoring
    Undergo medication adherence monitoring
    Other Names:
  • monitor

    • Other: Questionnaire Administration
    Ancillary studies
    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: Educational Activity
    Undergo parenting skills intervention

    Procedure: Patient Monitoring
    Undergo medication adherence monitoring
    Other Names:
  • monitor

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Change in parenting stress [Baseline up to 4 weeks post study]

      Pre and post intervention 15minute surveys

    2. Intervention feasibility [Up to 4 weeks post study]

      Assessed using survey assessments

    3. Change in parenting behaviors [Baseline up to 4 weeks]

      Pre and Post intervention 15 minute surveys

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Elizabeth Bouchard, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT03895918
    Other Study ID Numbers:
    • I 77618
    • NCI-2019-01554
    • I 77618
    First Posted:
    Mar 29, 2019
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    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
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Diseases

    Study Results

    No Results Posted as of Sep 16, 2021