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Stigma Healing Inventory Evaluation

9 ноября 2026 г. обновлено: St. Jude Children's Research Hospital

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

2980

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Dylan Graetz, MD, MPH
  • Номер телефона: 888-226-4343
  • Электронная почта: referralinfo@stjude.org

Места учебы

  • Соединенные Штаты
    • Tennessee
      • Memphis, Tennessee, Соединенные Штаты, 38105
        • Рекрутинг
        • St. Jude Children's Research Hospital
        • Контакт:
          • Dylan Graetz, MD, MPH
          • Номер телефона: 888-226-4343
          • Электронная почта: referralinfo@stjude.org
        • Главный следователь:
          • Dylan Graetz, MD, MPH

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

8 лет и старше (Ребенок, Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Pediatric Stigma Standard Education and Adapted Stigma Intervention

Aim 3 (See Detailed Description)
Другой: Pediatric Stigma Standard Education and Adapted Stigma Intervention

See Detailed Description
Активный компаратор: Pediatric Stigma Standard Education

Aim 3 (See Detailed Description)
Другой: Pediatric Stigma Education

See Detailed Description

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean change in patient stigma score from baseline to six months as reported by the KidsCanSHINE tool
Временное ограничение: Baseline and at 6 months (+/- 1 month)

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.
Baseline and at 6 months (+/- 1 month)
Mean change in caregiver stigma score from baseline to six months as reported by the CaregiversCanSHINE tool
Временное ограничение: Baseline and at 6 months (+/- 1 month)

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.
Baseline and at 6 months (+/- 1 month)
Changes in stigma score after intervention as reported by the KidsCanSHINE tool
Временное ограничение: Baseline, Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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).
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
Временное ограничение: Baseline, Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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).
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
Временное ограничение: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
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
Временное ограничение: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
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
Временное ограничение: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
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
Временное ограничение: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
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
Временное ограничение: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
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
Временное ограничение: At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Feasibility of Intervention
Временное ограничение: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Acceptability of Intervention
Временное ограничение: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Appropriateness of Intervention
Временное ограничение: Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)

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.
Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month)
Qualitative Interviews
Временное ограничение: Within 4 weeks of the final component of the intervention

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.
Within 4 weeks of the final component of the intervention

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

St. Jude Children's Research Hospital

Следователи

  • Главный следователь: Dylan Graetz, MD, MPH, St. Jude Children's Research Hospital

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 декабря 2026 г.

Первичное завершение (Оцененный)

1 декабря 2031 г.

Завершение исследования (Оцененный)

1 декабря 2031 г.

Даты регистрации исследования

Первый отправленный

23 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

14 октября 2026 г.

Первый опубликованный (Действительный)

20 октября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

10 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • SHINE
  • NCI-2026-01160 (Идентификатор реестра: NCI Clinical Trial Registration Program)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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.

Сроки обмена IPD

Data will be made available at the time of article publication.

Критерии совместного доступа к IPD

Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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