- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07682220
Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening
26 июня 2026 г. обновлено: Zhisheng Zheng, Harbin Medical University
Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening in High-risk Population: Randomized Controlled Trial and Intervention Disclosure Analysis
The goal of this clinical trial is to learn if a behavioral "nudge" strategy, specifically a default option, can improve screening participation in populations at high risk for lung and stomach cancer. The main questions it aims to answer are:
- Does presenting a screening appointment as a default option increase the likelihood that high-risk individuals will choose to be screened?
- How do participants react, and what is their level of acceptance, when the nudge intervention is disclosed to them?
- Does this transparency (disclosing the nudge) change their subsequent screening decisions? Researchers will compare a default option group to a standard control group to see if the nudge effectively increases screening adherence.
Participants will:
- Read a short educational text about lung or stomach cancer and its screening.
- Complete an online questionnaire.
- Make a decision regarding a simulated cancer screening appointment.
- Read a disclosure explaining the behavioral nudge strategy used during the study.
- Re-evaluate their screening decision and answer questions regarding their attitude toward the nudge.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
1200
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Heilongjiang
-
Harbin, Heilongjiang, Китай, 150081
- Harbin Medical University
-
-
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
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- High-risk population of lung cancer or gastric cancer.
- Lung cancer high-risk definition (based on the 2024 Lung Cancer Screening and Early Diagnosis and Treatment Program organized by the National Health Commission of the PRC): Age ≥50 years and pack-years of smoking ≥20, including former smoking ≥20 pack-years, but smoking cessation less than 15 years (Note: Pack-years of smoking = number of packs smoked per day × number of years smoked).
- Gastric cancer high-risk definition (based on the 2024 Gastric Cancer Screening and Early Diagnosis and Treatment Program organized by the National Health Commission of the PRC): Age ≥45 years old and living in areas with a high incidence of gastric cancer (Liaoning, Fujian, Gansu, Shandong, Jiangsu).
- Ability to read and comprehend simplified Chinese.
- The informed consent statement was read and confirmed.
Exclusion Criteria:
- Reading impairment preventing independent questionnaire completion.
- Failure to pass attention checks and logical consistency tests embedded within the questionnaire.
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: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: control group (lung cancer screening)
Control group participants received neutral, informational content about lung cancer and screening.
This content included lung cancer's status as a leading cause of cancer mortality, the challenges of late-stage diagnosis, and LDCT as the gold standard screening method.
Participants were informed that high-risk individuals, particularly long-term smokers, require annual screening due to elevated cancer risk, with each participant explicitly told they qualified as high-risk due to their smoking history.
Meanwhile, CanSPUC and its purpose were also shown to the participants.
The screening participation question for controls was framed as: "We provide available time slots for free lung cancer screening.
You can directly view available appointment times and make reservations according to your preference.
Would you like to schedule lung cancer screening?"
|
|
|
Экспериментальный: intervention group (lung cancer screening)
Intervention participants received the same neutral information plus a default option nudge.
The critical modification involved reframing the screening participation measure as: "We have already scheduled a free lung cancer screening appointment for you, which you can attend at your convenience.
If you do not wish to participate, please indicate below."
We also default to "Yes, I would like to make an appointment for lung cancer screening and see the available hours for lung cancer screening" for this question.
|
Participants in this arm are subjected to a behavioral "nudge" using a default option mechanism during a simulated online appointment process for cancer screening.
Instead of being asked to actively schedule an appointment (an opt-in approach), the screening appointment is presented to them as pre-selected or pre-scheduled (an opt-out approach).
Furthermore, to evaluate the ethical and behavioral impact of transparency, this intervention uniquely includes a "disclosure" phase: after the initial decision, participants are explicitly informed about the nudge strategy that was just applied to them, and their screening intention is immediately re-measured.
|
|
Без вмешательства: control group (gastric cancer screening)
Control group participants received neutral, informational content about gastric cancer and screening.
This content included gastric cancer's status as a cause of cancer mortality, the challenges of late-stage diagnosis, and endoscope as the gold standard screening method.
Participants were informed that high-risk individuals require screening per 5 years, with each participant explicitly told they qualified as high-risk due to their living regions.
Meanwhile, CanSPUC and its purpose were also shown to the participants.
The screening participation question for controls was framed as: "We provide available time slots for free gastric cancer screening.
You can directly view available appointment times and make reservations according to your preference.
Would you like to schedule gastric cancer screening?"
|
|
|
Экспериментальный: intervention group (gastric cancer screening)
Intervention participants received the same neutral information plus a default option nudge.
The critical modification involved reframing the screening participation measure as: "We have already scheduled a free gastric cancer screening appointment for you, which you can attend at your convenience.
If you do not wish to participate, please indicate below."
We also default to "Yes, I would like to make an appointment for gastric cancer screening and see the available hours for lung cancer screening" for this question.
|
Participants in this arm are subjected to a behavioral "nudge" using a default option mechanism during a simulated online appointment process for cancer screening.
Instead of being asked to actively schedule an appointment (an opt-in approach), the screening appointment is presented to them as pre-selected or pre-scheduled (an opt-out approach).
Furthermore, to evaluate the ethical and behavioral impact of transparency, this intervention uniquely includes a "disclosure" phase: after the initial decision, participants are explicitly informed about the nudge strategy that was just applied to them, and their screening intention is immediately re-measured.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants Who Accept the Cancer Screening Appointment
Временное ограничение: Immediately after the default option intervention
|
This outcome is assessed via a dichotomous choice (Yes/No) embedded in the simulated online scheduling system within the questionnaire.
The value reported will be the percentage of participants who choose to accept and schedule the screening appointment.
|
Immediately after the default option intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Participant Attitude Score Towards the Default Option Nudge
Временное ограничение: Immediately after the disclosure of the intervention
|
This measure is assessed via a self-reported questionnaire using a Likert scale.
Scores range from 1 to 5, where 1 indicates a very negative attitude and 5 indicates a very positive attitude.
Higher scores represent a better attitude towards the nudge strategy.
|
Immediately after the disclosure of the intervention
|
|
Self-Reported Score of the Nudge's Influence on Decision-Making
Временное ограничение: Immediately after the disclosure of the intervention
|
This measure is assessed via a self-reported questionnaire using a Likert scale.
Scores range from 1 to 5, where 1 indicates no influence and 5 indicates extreme influence.
Higher scores indicate that the participant felt the default option had a greater influence on their appointment decision.
|
Immediately after the disclosure of the intervention
|
|
Acceptance Score of the Default Option Nudge in Public Health Services
Временное ограничение: Immediately after the disclosure of the intervention
|
This measure is assessed via a self-reported questionnaire using a Likert scale.
Scores range from 1 to 5, where 1 indicates completely unacceptable and 5 indicates completely acceptable.
Higher scores indicate higher social acceptance and suitability of using such behavioral nudges in public health promotion.
|
Immediately after the disclosure of the intervention
|
|
Percentage of Participants Who Accept the Appointment After Disclosure
Временное ограничение: Immediately after the disclosure of the intervention
|
This outcome is assessed via a secondary dichotomous choice (Yes/No) presented after the participant reads the disclosure statement explaining the nudge.
The value reported is the percentage of participants who choose to accept the screening at this final stage.
|
Immediately after the disclosure of the intervention
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
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 (Действительный)
27 апреля 2025 г.
Первичное завершение (Действительный)
1 июня 2025 г.
Завершение исследования (Действительный)
1 июня 2025 г.
Даты регистрации исследования
Первый отправленный
23 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
26 июня 2026 г.
Первый опубликованный (Действительный)
2 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
2 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Заболевания желудка
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Поведение
- Приверженность и соблюдение режима лечения
- Поведение в отношении здоровья
- Принятие пациентом медицинской помощи
- Новообразования желудка
- Новообразования легких
- Соблюдение пациентом
Другие идентификационные номера исследования
- HMUIRB2025029PRE
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
All collected de-identified individual participant data (IPD) that underlie the results reported in the final publication.
This includes demographic characteristics, group allocation, behavioral screening decisions, and responses related to attitudes toward the disclosure intervention.
Сроки обмена IPD
Data will be available beginning 6 months and ending 36 months following the publication of the article.
Критерии совместного доступа к IPD
Researchers who provide a methodologically sound proposal.
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. .