RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)

Recruiting

• Conditions: Stigma

• Registration Number: NCT06470230
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

Researchers want to learn more about the way stigma affects children with cancer and their caregivers. They want to develop two clinical tools to identify and measure stigma in the pediatric cancer population within culturally diverse global settings of the United States, Guatemala, and Jordan.

Primary Objectives
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Detailed Description

There are 2 parts to this study; participants will be included in either Part 1 or Part 2, but not both.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Status Verified: 2024-07
• Study Start: 2024-07-08
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 972

Inclusion Criteria

• Cognitive Debriefing and Pilot Data Collection - Patients/Survivors

  • Age 8 to 17.9 years of age
  • Active cancer patients or survivors of cancer

• Cognitive Debriefing and Pilot Data Collection - Parent/Caregivers

  • Adult parents or caregivers (> 18 years of age) of active cancer patients or survivors of cancer.

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Exclusion Criteria

NA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings.	Up to 2 months after the start of study	Concept mapping, a mixed-methods approach, combining qualitative group brainstorming and sorting with descriptive statistical analysis will be utilized to describe ideas and represent them graphically. Content expert participants, including members of the research team and global healthcare professionals, will generate novel items by answering prompts. Parti...
Pilot new stigma tools in geographically and culturally diverse cancer referral settings.	Approximately one year after the start of study	Pilot data will be analyzed using R. Data will be descriptively analyzed before psychometric analysis focusing on item- and domain-level characteristics, including inter-item correlation and scale internal consistency (Cronbach's alpha). Confirmatory factor analysis will test the structural validity (i.e., dimensionality) of the tools. The tools will be refi...

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States