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Идёт набор NCT06808776

Stories to Prevent (StoP) HPV Cancers

Без фазы С лечением Human Papillomavirus Vaccination Emotions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cancer survivor narrative, Healthy eating tips.
Кому может быть актуально
Состояния в реестре: Human Papillomavirus Vaccination, Emotions. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Stories to Prevent (StoP) HPV Cancers: A Communication Intervention to Increase HPV Vaccination Among Diverse Populations.

Обзор

This randomized controlled trial (RCT) evaluates the association of a narrative communication intervention on human papillomavirus (HPV) vaccination rates among 9- to 12-year-olds. The intervention is a brief video from local cancer survivors narrating their stories with an HPV-related cancer diagnosis and recommending the HPV vaccine for cancer prevention. RCT participants will be the parents (n=200) of children ages 9-12 who have not initiated HPV vaccination. Participants will be randomized (1:1) to our intervention or control (placebo video) one week before their child's next primary care visit. Our primary outcome is HPV vaccine initiation (first dose of the HPV vaccine series) among children ages 9-12 at the time of the wellness visit. The study also explores the effect of narratives on theory-based mediators of HPV vaccination, including parents' cognitive (e.g., risk perception) and emotional reactions (e.g., hope, anticipated regret).

Подробное описание

Despite the availability of the human papillomavirus (HPV) vaccine that can prevent over 37,300 HPV-related cancers in the US every year, only 62.6% of girls and boys were up-to-date in 2022. Low-quality provider recommendations and time constraints during clinic visits limit parents' opportunities to discuss and make HPV vaccination decisions. Pre-visit education to parents could complement provider communication to promote HPV vaccination. There is a critical need to identify better communication strategies to increase HPV vaccine uptake, including the use of narrative messaging and existing digital technologies in clinics and at home (electronic health records, patient portal, mobile devices). The Stories to Prevent (StoP) HPV Cancers Study is a randomized controlled trial (RCT) to evaluate the association of a narrative communication intervention delivered through digital and mobile technology before clinic visits on HPV vaccine initiation rates. A sample of 200 parents of unvaccinated children ages 9-12 will be randomized to receive our intervention or control (placebo video). Participants will be recruited from general pediatric and family medicine clinics affiliated with Penn State Health. We will also examine the effect of narrative communication on theory-based psychological mediators of HPV vaccine initiation and narrative communication processes, specifically parents' cognitive and emotional reactions.

Вмешательства

  • Другое Cancer survivor narrative
    The narrative video intervention has three parts: (1) Cancer experience - the cancer survivor narrates his/her experience with an HPV-related cancer, including diagnosis, treatment, and how cancer affected their personal life or family; (2) Vaccine recommendation - the cancer survivor provides brief information about the safety and effectiveness of the HPV vaccine and recommend that parents get the HPV vaccine for their child to prevent cancers; and (3) Closing message - The sentence "HPV vaccin
  • Другое Healthy eating tips
    A publicly available video about healthy eating tips for families with children.

Первичные конечные точки

  • HPV vaccine initiation, 9-12 year olds [Срок оценки: One week after clinic visit]
Вторичные конечные точки (10)
  • HPV vaccine initiation stratified by age [Срок оценки: One week after clinic visit]
  • HPV vaccine initiation stratified by sex [Срок оценки: One week after clinic visit]
  • HPV vaccine initiation stratified by race/ethnicity [Срок оценки: One week after clinic visit]
  • HPV vaccine communication in clinics [Срок оценки: One week after clinic visit]
  • Believability [Срок оценки: One week after the intervention]
  • Character identification [Срок оценки: One week after the intervention]
  • Health beliefs [Срок оценки: One week after the intervention]
  • Positive affect [Срок оценки: One week after the intervention]
  • Negative affect [Срок оценки: One week after the intervention]
  • Acceptability of digital health interventions [Срок оценки: One week after the intervention]

Критерии участия

Критерии включения

  • Parent/guardian of a 9-12 year old receiving primary care at a Penn State Health clinic
  • Their child has not previously received or initiated the HPV vaccine
  • Is able to read and understand spoken English or Spanish
  • Has a valid email address and access to a mobile phone, table, desktop or laptop computer to engage in the intervention

Критерии исключения

  • Parent of guardian is less than 18 years of age
  • Unable to read and understand spoken English or Spanish
  • Does not have access to a mobile phone, table, desktop or laptop computer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Penn State Health — Hershey

Идентификаторы

NCT: NCT06808776 · STUDY00025798

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗