Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07882927

Conditions

Stigma

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

Pediatric Stigma Education

Pediatric Stigma Standard Education and Adapted Stigma Intervention

Study Details

Brief 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.

Conditions

Stigma

Study ID

NCT07882927

Start date

Dec, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Inclusion Criteria, AIM 1:

  • 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).

Inclusion Criteria, AIM 3:

  • 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.

Study Design

Enrollment

2980 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pediatric Stigma Standard Education and Adapted Stigma Intervention

Aim 3 (See Detailed Description)

active comparator: Pediatric Stigma Standard Education

Aim 3 (See Detailed Description)

Interventions

Pediatric Stigma Education

See Detailed Description

Pediatric Stigma Standard Education and Adapted Stigma Intervention

See Detailed Description

Primary outcome measure

  • Mean change in patient stigma score from baseline to six months as reported by the KidsCanSHINE tool [ Time Frame: Baseline and at 6 months (+/- 1 month) ]
  • Mean change in caregiver stigma score from baseline to six months as reported by the CaregiversCanSHINE tool [ Time Frame: Baseline and at 6 months (+/- 1 month) ]
  • Changes in stigma score after intervention as reported by the KidsCanSHINE tool [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) ]
  • Feasibility of Intervention [ Time Frame: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) ]
  • Acceptability of Intervention [ Time Frame: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) ]
  • Appropriateness of Intervention [ Time Frame: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) ]
  • Qualitative Interviews [ Time Frame: Within 4 weeks of the final component of the intervention ]

Central Contacts and Locations

Central contacts

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Principal Investigator:

Dylan Graetz, MD, MPH

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Cancer Related Stigma
  • Pediatric Oncology
  • Cross-cultural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.