StigmaNCT06470230
RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)
An observational study of Stigma, run by St. Jude Children's Research Hospital at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stigma
- How many people
- 633 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 8 Jul 2024to 6 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Active cancer patients or survivors of cancer and adult parents or caregivers of active cancer patients or survivors of cancer.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Washington University School of Public Health
St Louis, Missouri, 63110
About this study
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.
Read the 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.
We will recruit up to 20 active patients and/or survivor participants aged 8-17.9 in each language (up to 60 total patient/survivor participants), and similar numbers of parents or caregivers (not recruited as dyads) and ask 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 225-600 active patients or survivor participants (75-200 in each language) and 225-600 parents or caregivers (75-200 in each language) to pilot the tools.
- Conditions
- Stigma
- Keywords
- Cancer Related Stigma, Pediatric Cancer Population, Parent/Caregivers, Patients/Survivors, Diverse global settings
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately one year after the start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start8 Jul 2024
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StigmaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dylan Graetz, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470230
- Sponsor's protocol ID
- RESPECT
- Other IDs
- P30CA021765-44S2
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)
- ClinicalTrials.gov ID
- NCT06470230
- Acronym / sponsor ID
- RESPECT
- Conditions
- Stigma
- Keywords
- Cancer Related Stigma, Pediatric Cancer Population, Parent/Caregivers, Patients/Survivors, Diverse global settings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
We will recruit up to 20 active patients and/or survivor participants aged 8-17.9 in each language (up to 60 total patient/survivor participants), and similar numbers of parents or caregivers (not recruited as dyads) and ask 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 225-600 active patients or survivor participants (75-200 in each language) and 225-600 parents or caregivers (75-200 in each language) to pilot the tools.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Active cancer patients or survivors of cancer and adult parents or caregivers of active cancer patients or survivors of cancer.
Key inclusion criteria (5 listed)
- Cognitive Debriefing and Pilot Data Collection - Patients/Survivors
- Cognitive Debriefing and Pilot Data Collection - Parent/Caregivers
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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. 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.
Pilot new stigma tools in geographically and culturally diverse cancer referral settings.
Time frame: 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Graetz, MD principal investigator
St. Jude Children's Research Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stigma, run by St. Jude Children's Research Hospital at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Guatemala, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 2 months after the start of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.