Overview
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.
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.
Eligibility
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.
