Status:

COMPLETED

Validation Study of Pediatric Patient-Reported Outcomes

Lead Sponsor:

St. Jude Children's Research Hospital

Collaborating Sponsors:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Children's Hospital of Philadelphia

Conditions:

Tumor

Malignancy

Eligibility:

All Genders

8-18 years

Brief Summary

Survivors of childhood cancer often suffer treatment-related toxicities, including chronic health conditions, high symptom burden and emotional distress, and decremented functional status and quality ...

Detailed Description

A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9 years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the After Comple...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for Childhood Survivors:
  • St. Jude childhood cancer survivors who have consented to SJLIFE;
  • Age at assessment: 8-18.9 years at T1 (toward 20.9 years at T3);
  • 2 years off therapy and \> 5 years since diagnosis; and
  • Agrees to complete three annual assessments during routinely scheduled ACT clinic appointments.
  • Exclusion Criteria for Childhood Survivors:
  • Cancer-related or unrelated (e.g., genetic disorders) neurocognitive injuries that requires parents/proxies to complete the survey \[e.g. intelligence quotient (IQ) \<70\];
  • Inability to read and speak English; or
  • Parent doesn't agree to participate in the parent part of the study.
  • Inclusion Criteria for Parents/Legal Guardians:
  • Parent/legal guardian of St. Jude childhood cancer survivor aged 8-18.9 who is eligible to participate and has agreed to do so;
  • Participant is not developmentally delayed, intellectually disabled or non-communicative; and
  • Participant speaks and understands the English language.
  • Exclusion Criteria for Parents/Legal Guardians:
  • Developmentally delayed, intellectually disabled or non-communicative;
  • Unable to speak or understand the English language; and
  • Child doesn't agree to participate in child part of the study.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2017

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 30 2025

    Estimated Enrollment :

    303 Patients enrolled

    Trial Details

    Trial ID

    NCT03229837

    Start Date

    August 1 2017

    End Date

    June 30 2025

    Last Update

    August 27 2025

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    St. Jude Children's Research Hospital

    Memphis, Tennessee, United States, 38105