NCT05150028

Brief Summary

To develop a cancer center level practice intervention to promote treatment adherence and reduce outcome disparities in pediatric cancer survivors

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

November 24, 2021

Last Update Submit

September 12, 2024

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • Retention rates

    Feasibility of intervention as assessed by retention rates

    Up to 8 weeks

Secondary Outcomes (2)

  • Feasibility of universal SDOA screening

    up to 8 weeks

  • Provider satisfaction with barrier reports

    up to 8 weeks

Study Arms (2)

Intervention - Pediatric parent/caregiver

EXPERIMENTAL

Questionnaires along with educational videos

Behavioral: Patient participation

Clinicians

EXPERIMENTAL

Will complete pre and post survey about medication education practices

Other: Clinician barrier reports

Interventions

Patient participationBEHAVIORAL

Questionnaire

Intervention - Pediatric parent/caregiver
Clinician barrier reportsOTHER

How many times a 7 question Survey on medication education practices is opened

Clinicians

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents/caregivers of pediatric patients must meet the following criteria to be eligible:
  • Parents/guardians of child that has been diagnosed with any cancer.
  • Parents/guardians of child with any cancer between age 0 and 18.
  • Parents/guardians of child on home-based oral anti-cancer therapy or supportive care therapy.
  • The clinician for the family agrees to participate in the study.

You may not qualify if:

  • Participants will be excluded from this study if unwilling or unable to complete the assessment in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Elizabeth Bouchard, MD

    Roswell Park Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 8, 2021

Study Start

April 11, 2023

Primary Completion

June 6, 2023

Study Completion

June 6, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

US(1)