Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470230
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-17
Brief Title:
RESPECT REsearching Stigma in PEdiatric Cancer Tool
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
RESPECT REsearching Stigma in PEdiatric Cancer Tool
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientssurvivors and 2 their guardianscaregivers in culturally diverse global settings
Pilot new stigma tools in geographically and culturally diverse cancer referral settings in 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 patientssurvivors and 2 their guardianscaregivers in culturally diverse global settings
Pilot new stigma tools in geographically and culturally diverse cancer referral settings in the United States Guatemala and Jordan
Detailed Description:
There are 2 parts to this study participants will be included in either Part 1 or Part 2 but not both
In Part 1 of the study investigators will conduct a systematic literature review of tools measuring stigma in healthcare at the level of the patient and survivor or caregiver through which they will catalog all items included in existing instruments of the study Literature will be searched for concepts of patient self-stigma and scales instruments measurements or outcomes
Once the search strategy is completed a panel of experts will review items and domains sorts to remove confusing or duplicative items and produce final pilot tools containing patient-centered and clinically relevant items Preliminary tools will be translated into Spanish and Arabic The preliminary English tools will be professionally translated into Spanish and Arabic Translated tools will be reviewed by international study teams as well as bilingual members of the St Jude team to account for regional linguistic differences The Spanish and Arabic tools will be back translated into English to ensure original intent is maintained Any modifications needed to ensure language consistency across versions will be made in all languages ensuring parallel versions of the tool are developed
Around 12 children aged 8-179 who have or had cancer will be recruited in each language 36 total participants and similar numbers of parents or caregivers not recruited as dyads will be recruited and asked questions about stigma Experienced interviewers trained by the St Jude team will verbally administer the tool followed by probing questions to assess face validity and rate each item on a scale of 1-5 based on accuracy clarity and difficulty of content After 3-4 participants have been interviewed in each language all three tools will be reassessed with modifications made as necessary This process will be repeated until no additional modifications are identified through interviews
In Part 2 of the study children who have or had cancer and their caregivers will test out the questionnaire that was created during Part 1 of the study Investigators will recruit 225-450 active patients or survivor participants 75-150 in each language and 225-450 parents or caregivers 75-150 in each language to pilot the tools
In Part 1 of the study investigators will conduct a systematic literature review of tools measuring stigma in healthcare at the level of the patient and survivor or caregiver through which they will catalog all items included in existing instruments of the study Literature will be searched for concepts of patient self-stigma and scales instruments measurements or outcomes
Once the search strategy is completed a panel of experts will review items and domains sorts to remove confusing or duplicative items and produce final pilot tools containing patient-centered and clinically relevant items Preliminary tools will be translated into Spanish and Arabic The preliminary English tools will be professionally translated into Spanish and Arabic Translated tools will be reviewed by international study teams as well as bilingual members of the St Jude team to account for regional linguistic differences The Spanish and Arabic tools will be back translated into English to ensure original intent is maintained Any modifications needed to ensure language consistency across versions will be made in all languages ensuring parallel versions of the tool are developed
Around 12 children aged 8-179 who have or had cancer will be recruited in each language 36 total participants and similar numbers of parents or caregivers not recruited as dyads will be recruited and asked questions about stigma Experienced interviewers trained by the St Jude team will verbally administer the tool followed by probing questions to assess face validity and rate each item on a scale of 1-5 based on accuracy clarity and difficulty of content After 3-4 participants have been interviewed in each language all three tools will be reassessed with modifications made as necessary This process will be repeated until no additional modifications are identified through interviews
In Part 2 of the study children who have or had cancer and their caregivers will test out the questionnaire that was created during Part 1 of the study Investigators will recruit 225-450 active patients or survivor participants 75-150 in each language and 225-450 parents or caregivers 75-150 in each language to pilot the tools
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA021765-44S2 | NIH | None | None |