StigmaNCT07882927
Stigma Healing Inventory Evaluation
A study testing Pediatric Stigma Education and Pediatric Stigma Standard Education and Adapted Stigma Intervention in people with Stigma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Investigators want to learn more about the way stigma affects children with cancer and their caregivers. They hope to develop an intervention to lessen stigma for children with cancer and their caregivers in settings around the world. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Stigma
- What is being tested?
- Pediatric Stigma Education and Pediatric Stigma Standard Education and Adapted Stigma Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,980 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2031
- Phase
- Interventional
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children with cancer who are actively receiving chemotherapy, radiation, and/or surgery or caregivers of children with cancer actively receiving chemotherapy, radiation, and/or surgery
- Ages 8 to 17.9 years (patients); age 18+ (caregivers)
- Speaks Arabic, English, or Spanish (St. Jude will enroll English-speakers only).
- Children with cancer who are actively receiving chemotherapy, radiation, and/or surgery or caregivers of children with cancer actively receiving chemotherapy, radiation, and/or surgery
- Ages 8 to 17.9 years (patients); age 18+ (caregivers)
- Speaks Arabic, English, or Spanish (St. Jude will enroll English-speakers only)
- Experienced moderate-high scores in at least 1 domain as assessed by baseline KidsCanSHINE or CaregiversCanSHINE survey assessments.
- Specify any clinical (e.g., life expectancy, co-existing disease demographic (e.g., age) or other characteristics that preclude appropriate diagnosis, treatment or follow-up in the trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Dylan Graetz, MD, MPH, 888-226-4343, referralinfo@stjude.org
Dylan Graetz, MD, MPH
About this study
Investigators want to learn more about the way stigma affects children with cancer and their caregivers. They hope to develop an intervention to lessen stigma for children with cancer and their caregivers in settings around the world.
Read the detailed description
Primary Objective 1
- Characterize stigma, including assessment of prevalence of different aspects across three domains and risk factors in diverse pediatric cancer populations.
Primary Objective 2
- Develop and adapt an intervention to improve stigma for children with cancer and their caregivers globally.
Primary Objective 3
- Pilot the preliminary efficacy, feasibility, appropriateness, and acceptability of a patient intervention program to reduce stigma for childhood cancer patients and their caregivers.
The investigators anticipate approximately 1,400 patient enrollees and 1,400 caregiver enrollees (2,800 total) for Aim 1 and 90 dyads (180 total) for Aim 3.
Aim 1:
Approximately 80-100 patients and 80-100 caregivers will be enrolled from each participating center, leading to 1,120-1,400 2,240-2,800 enrollees.
The KidsCanShine and the CaregiversCanShine survey tools will be administered two times to participants. The survey will be administered verbally, on an iPad, or via survey link based on a combination of site resources and preferences, as well as patient preference and abilities. After the first timepoint, participants will remain enrolled in the study for six months. Six months (+/- 1 month) after initial enrollment and survey completion, study team members will reach out to patients and their caregivers and ask them to complete the same survey at this second time point. At the conclusion of this second survey, participants will be finished with the study.
Aim 2 does not involve participant interaction. The goal of this Aim is to develop the intervention that will be randomized and delivered to participants during Aim 3.
Aim 3: Investigators will pilot the stigma reduction intervention and test its preliminary efficacy. In this clustered randomized control trial (RCT), investigators will compare 3 sites randomized to the fully developed intervention and 3 sites randomized to education only, delivered via patient referral to the Together platform and provision of Together educational materials. The 6 sites will be determined based on the results of Aim 1 and site interest.
The intervention will include multiple sessions, group and individual, covering various components aligned with our conceptual model and the domains assessed via KidsCanSHINE and CaregiversCanSHINE. Sessions will include beliefs and myths, cancer education, disclosure, mindfulness, and storytelling. Core components will be fixed across sites; however, there will be an opportunity to contextually specify certain content (e.g., regarding local myths). The intervention will also include the existing Together by St. Jude platform, a comprehensive multilingual online educational platform for pediatric cancer. In addition to general pediatric cancer education, this platform contains material on myth busting, storytelling. and narrative medicine. Existing material and the Together team's support will be used to develop additional stigma-tailored content as needed. The Together platform will be used in the intervention and serve as the education control in Aim 3, due to its wide accessibility in 12 languages.
Patients and clinicians who complete the intervention, will also be asked to complete three validated survey measures. These are the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Interviews will be done with patients and clinicians involved in Aim 3. Interviews will be individual and will look at the experiences of the intervention and stigma in pediatric cancer.
- Conditions
- Stigma
- Being tested
- Pediatric Stigma Education, Pediatric Stigma Standard Education and Adapted Stigma Intervention
- Keywords
- Cancer Related Stigma, Pediatric Oncology, Cross-cultural
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Stigma EducationOther
See Detailed Description
Pediatric Stigma Standard Education and Adapted Stigma InterventionOther
See Detailed Description
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Stigma Standard Education and Adapted Stigma Intervention | Experimental | Aim 3 (See Detailed Description) Receives: Other: Pediatric Stigma Standard Education and Adapted Stigma Intervention |
| Pediatric Stigma Standard Education | Active comparator | Aim 3 (See Detailed Description) Receives: Other: Pediatric Stigma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in patient stigma score from baseline to six months as reported by the KidsCanSHINE tool
KidsCanSHINE survey tool inquires about the experience of stigma in multiple dimensions and about related patient reported quality of life metrics, information on their diagnosis and treatment course, perceptions of care quality, and demographic information (sex, age, school information, treating institution), This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma.
Measured: Baseline and at 6 months (+/- 1 month)
Mean change in caregiver stigma score from baseline to six months as reported by the CaregiversCanSHINE tool
The CaregiversCanSHINE survey tool inquires about the experience of stigma in multiple dimensions and about information related to being a caregiver of a child with cancer, including reported quality of life metrics, information on their child's diagnosis and treatment course, perceptions of care quality, and demographic information (sex, age at diagnosis, relationship to the patient, etc). This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma.
Measured: Baseline and at 6 months (+/- 1 month)
Changes in stigma score after intervention as reported by the KidsCanSHINE tool
The KidsCanSHINE survey tool inquires about the experience of stigma in multiple dimensions. This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma. Individuals will complete the assessments at baseline, immediately after the intervention, and at conclusion of the pilot (six months after intervention).
Measured: Baseline, Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Changes in stigma score after intervention as reported by the CaregiversCanSHINE tool
The CaregiversCanSHINE survey tool inquires about the experience of stigma in multiple dimensions. This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma. Individuals will complete the assessment at baseline, immediately after the intervention, and at conclusion of the pilot (six months after intervention).
Measured: Baseline, Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Characterization of Internalized Stigma as reported by the KidsCanSHINE tool
The KidsCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Internalized Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Internalized Stigma score as reported by patients.
Measured: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Characterization of Perceived Stigma as reported by the KidsCanSHINE tool
The KidsCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Perceived Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Perceived Stigma score as reported by patients.
Measured: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Characterization of Discrimination Experiences as reported by the KidsCanSHINE tool
The KidsCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Discrimination Experiences. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Discrimination Experiences score as reported by patients.
Measured: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Characterization of Internalized Stigma as reported by the CaregiversCanSHINE tool
The CaregiversCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Internalized Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Internalized Stigma score as reported by caregivers.
Measured: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Characterization of Perceived Stigma as reported by the CaregiversCanSHINE tool
The CaregiversCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Perceived Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Perceived Stigma score as reported by caregivers.
Measured: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Characterization of Discrimination Experiences as reported by the CaregiversCanSHINE tool
The CaregiversCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Discrimination Experiences. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Discrimination Experiences score as reported by caregivers.
Measured: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Feasibility of Intervention
Participants and clinicians who complete the intervention will be asked to complete the Feasibility of Intervention Measure (FIM). The FIM is used to assess how feasible it is to implement a specific intervention. The FIM measure includes four itemized responses that are scored from one to five (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). Higher scores indicate greater perceived feasibility of the intervention.
Measured: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Acceptability of Intervention
Participants and clinicians who complete the intervention will be asked to complete the Acceptability of Intervention Measure (AIM). The AIM is a four-item scale used to assess the acceptability of an intervention. It includes four itemized responses that are scored from one to five (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). Higher scores indicating greater acceptability.
Measured: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Appropriateness of Intervention
Participants and clinicians who complete the intervention will be asked to complete the Appropriateness Measure (IAM). The Intervention Appropriateness Measure (IAM) is a four-item scale used to assess the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs. Each item is rated on a 5-point Likert scale (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). A higher score on the IAM indicates a stronger perception that the intervention is appropriate for the given situation and context.
Measured: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Qualitative Interviews
The investigators will conduct a qualitative assessment on experiences of the intervention and stigma in pediatric cancer. Audio recordings of qualitative data will be translated and transcribed into English. Transcripts will be de-identified, segmented, and uploaded to MAXQDA for analysis.
Measured: Within 4 weeks of the final component of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dylan Graetz, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882927
- Sponsor's protocol ID
- SHINE
- Other IDs
- NCI-2026-01160
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.