COMPLETED

The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial

Talk to us

Conditions

Cerebral Palsy InfantileDisabilities MultiplePainDisabled childrenpalliative careelectronic patient reported outcomes measuresSevere neurologic impairment

Quick Navigation

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

The goal of this pilot randomized controlled trial is to test the feasibility of running a full scale randomized controlled trial that compares the effect of the PQ-ResPOND intervention versus usual care to improve recurrent pain in children, adolescents, and young adults with severe neurologic impairment. The main questions it aims to answer are: * Is the study feasible and acceptable for participants? * Does PQ-ResPOND have a potential to be effective? Participants will: * answer surveys (their parents will) telling us about the child's pain, symptoms, and use of complementary therapies, and about their own psychological distress and satisfaction with care. * a group will receive the PQ-ResPOND intervention which consists of: * activating parents and providers by using the PediQUEST system, a web platform that administers surveys and generates feedback reports alerting parents and providers about the child's experience, AND * responding to child pain or discomfort by incorporating the Response team (members of the hospital's palliative care team) into the child's care to privde a standardized approach to managing recurrent pain. Researchers will use a comparison (control) group consisting of participants who will answer surveys and receive usual care (no feedback reports or consult with palliative care in this group) to see if a randomized design is feasible.

Official Title

Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)

Quick Facts

Study Start:2024-05-08
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06075797

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:1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Parent-child dyads will be included based on the following criteria:
  2. * ≥ 1 year old,
  3. * receiving routine (ongoing) care at Boston Children's Hospital, AND
  4. * followed by the Neurology, Cerebral Palsy or Complex Care services.
  5. * has severe neurological impairment, defined as:
  6. * a Central Nervous System disorder resulting in motor and cognitive impairment and an inability to communicate either verbally or through sign language, AND
  7. * has complete caregiver dependency for activities of daily living AND
  8. * date of diagnosis of SNI is ≥ 4 months prior to the date of screening
  1. * Parent-child dyads will be excluded if any of the following apply:
  2. * the child,
  3. * is already followed by the palliative care team, OR
  4. * is not expected to survive at least 2 months after enrollment; OR
  5. * does not have "moderate to severe recurrent pain", as measured through the baseline Child Pain Survey (PPP). Specifically, we will exclude participants whose:
  6. * "Good days" AND "Difficult days" PPP scores are \<14, AND
  7. * "Most troublesome pain" PPP score is \<30, AND
  8. * Number of "difficult days" are \<8 in past month, AND
  9. * Number of days with "most troublesome pain" are \<4 in past month; OR • both parents,
  10. * do not have legal guardianship, OR
  11. * are unable to read, write, and speak English OR Spanish
  12. * are unable to understand and complete surveys.

Contacts and Locations

Principal Investigator

Joanne Wolfe, MD, MPH
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

University of Alabama, Birmingham
Birmingham, Alabama, 35294
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Joanne Wolfe, MD, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2024-05-08
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2024-05-08
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Disabled children
  • pain
  • palliative care
  • electronic patient reported outcomes measures
  • Severe neurologic impairment

Additional Relevant MeSH Terms

  • Cerebral Palsy Infantile
  • Disabilities Multiple
  • Pain