RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)

NCT06470230 | Completed

• 2 other identifiers: RESPECTP30CA021765-44S2
• Study Type: observational
• Target: 633
• Locations: 3 countries
• Sites: 4

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

• 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.
• Pilot new stigma tools in geographically and culturally diverse cancer referral settings in the United States, Guatemala, and Jordan.

Conditions

Stigma

Keywords

Cancer Related Stigma; Pediatric Cancer Population; Parent/Caregivers; Patients/Survivors; Diverse global settings

Outcome Measures

Primary Outcomes (2)

• 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.

  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. Participants will sort the items into distinctive themes and conduct cluster analyses to create an initial concept map that improves understanding of stigma domains and will be asked to rate the importance and feasibility of each item. A panel of experts will review the item and domain sorts and ratings to remove confusing or duplicative items and produce final pilot tools containing patient-centered and clinically relevant items. Pragmatic design principles will be used to make the tools short and easy to use in a variety of settings.

  Up to 2 months after the start of study

• Pilot new stigma tools in geographically and culturally diverse cancer referral settings.

  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 refined by dropping items, changing domains, or editing language. The analyses will highlight items that have poor fit and the expert team will review these items and make relevant updates to the overall measure based on these analyses and feedback regarding usability. This will result in a final version of the tools in all three languages.

  Approximately one year after the start of study

Study Arms (2)

Pediatric oncology patients/survivors

Children who have or had cancer

Guardians/caregivers of pediatric oncology patients/survivors

Parents or caregivers of children who have or had cancer

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active cancer patients or survivors of cancer and adult parents or caregivers of active cancer patients or survivors of cancer.

You may qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Washington University School of Public Health

St Louis, Missouri, 63110, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

UNOP Unidad Nacional De Oncologia Pediatrica

Guatemala City, Guatemala

Location

King Hussein Cancer Center

Amman, Jordan

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Dylan Graetz, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: July 8, 2024
• Primary Completion: March 6, 2026
• Study Completion: March 6, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (2); JO (1); GU (1)