RECRUITING

COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).

Official Title

A Qualitative Cognitive Interview Study to Evaluate Comprehensibility and Content Validity of a Caregiver Observer-reported Assessment and a Clinician-reported Assessment of Acute Pain in Infants and Young Children Who Are 0 to <2 Years of Age.

Quick Facts

Study Start:2023-08-15

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06164028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Cares for a child who is both: Between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions * Is over the age of 18 years * Can speak and understand English or Spanish * Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record. * Practicing clinician in a clinical care environment * Treats or works with pediatric patients who are between 0 and \<2 years of age AND being treated for acute pain. * Cares for pediatric patients \>50% of their clinical time. * Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher) * Is over the age of 18 years * Can speak and understand English * Is capable of and willing to provide informed consent for interview participation.	* Lack of access to a telephone or computer for interview * For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.

Inclusion Criteria

Exclusion Criteria

* Cares for a child who is both: Between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions
* Is over the age of 18 years
* Can speak and understand English or Spanish
* Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record.
* Practicing clinician in a clinical care environment
* Treats or works with pediatric patients who are between 0 and \<2 years of age AND being treated for acute pain.
* Cares for pediatric patients \>50% of their clinical time.
* Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher)
* Is over the age of 18 years
* Can speak and understand English
* Is capable of and willing to provide informed consent for interview participation.

* Lack of access to a telephone or computer for interview
* For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.

Contacts and Locations

Study Contact

Sophie Wang, MBBS, MHS

CONTACT

919-668-5971

sophie.wang@duke.edu

Principal Investigator

Kanecia Zimmerman, MD, MPH

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke Clinical Research Institute

Durham, North Carolina, 27701

United States

Collaborators and Investigators

Sponsor: Duke University

Kanecia Zimmerman, MD, MPH, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2023-08-15

Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

Acute Pain