RECRUITING

Integrative Training Program for Pediatric Sickle Cell Pain

Talk to us

Conditions

Sickle Cell DiseaseSickle Cell PainLifestyle considerationsPediatricsBehavioral interventionMind-body intervention

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

This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms? The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health. The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.

Official Title

Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial

Quick Facts

Study Start:2024-12
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06691867

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:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form for adolescents 18 years old and caregivers' participation
  2. * For children \<18, informed assent and parental informed consent to participate in the study
  3. * Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  4. * Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers
  5. * Documented diagnosis of sickle cell disease (any genotype) for adolescents
  6. * Adolescent scores at least 3 on the Pediatric Pain Screening Tool
  7. * Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cm Visual Analog Scale
  8. * Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea, glutamine, voxelotor, crizanlizumab) as defined by not newly initiated or significantly increased dosages (mg/kg) in the past 3 months
  9. * Speak and read English
  1. * An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
  2. * Adolescent has undergone genetic or hematopoietic stem cell therapy
  3. * Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation
  4. * Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention

Contacts and Locations

Study Contact

Soumitri Sil, PhD, ABPP
CONTACT
404-727-2712
sil@emory.edu

Principal Investigator

Soumitri Sil, PhD, ABPP
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Emory University

  • Soumitri Sil, PhD, ABPP, PRINCIPAL_INVESTIGATOR, Emory 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 Date2024-12
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-12
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • Sickle Cell Pain
  • Lifestyle considerations
  • Pediatrics
  • Behavioral intervention
  • Mind-body intervention

Additional Relevant MeSH Terms

  • Sickle Cell Disease