RECRUITING

DMD Voice: Qualitative Interviews With Patients and Caregivers

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 purpose of this study is to understand DMD functional losses or abilities and their association with independence and quality of life from the perspective of individuals with DMD and/or and their caregivers. This is a qualitative interview study in which individuals with DMD and/or their caregivers will be asked to participate in a semi-structured, approximately 60- minute interview. Interviews will focus on functional abilities and independence. Caregivers and boys with DMD will be interviewed. This study includes no treatment nor intervention; however, some participants are being treated by a drug that is approved in the U.S. and the U.K. and under investigation in other geographies.

Official Title

Duchenne Muscular Dystrophy Quality of Life: Qualitative Interviews With Patients and Caregivers

Quick Facts

Study Start:2025-04-04
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06925269

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:10 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have been treated with Givinostat for at least 2 years
  2. * Be at least 10 years of age with signed consent of a parent or legal guardian
  3. * Be currently taking givinostat
  4. * Willing and able to participate in a video and/or audio recorded interview
  5. * Be a parent or legal guardian of an individual with DMD that has been taking givinostat for at least two years
  6. * Willing and able to participate in a video and/or audio recorded interview
  7. * Provide care to an individual with DMD who is unable to raise their hands above their head as confirmed by the caregiver
  8. * Reside in the United States or Canada
  9. * Able to read, speak, and understand English
  10. * Willing and able to participate in a video and/or audio recorded interview Have access to a stable internet connection
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mary Hubbard
CONTACT
904-541-9326
mhubbard@rednucleus.com

Principal Investigator

Mindy Leffler, M.Ed.
PRINCIPAL_INVESTIGATOR
Red Nucleus Solutions

Study Locations (Sites)

Red Nucleus
Yardley, Pennsylvania, 19067
United States

Collaborators and Investigators

Sponsor: Red Nucleus Enterprise Solutions, LLC

  • Mindy Leffler, M.Ed., PRINCIPAL_INVESTIGATOR, Red Nucleus Solutions

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 Date2025-04-04
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-04-04
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Duchenne
  • givinostat

Additional Relevant MeSH Terms

  • Duchenne Muscular Dystrophy (DMD)