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- Ensayo clínico NCT07682220
Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening
26 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150081
- Harbin Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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?"
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|
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Experimental: 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.
|
|
Sin intervención: 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?"
|
|
|
Experimental: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Who Accept the Cancer Screening Appointment
Periodo de tiempo: 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.
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Immediately after the default option intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant Attitude Score Towards the Default Option Nudge
Periodo de tiempo: 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.
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Immediately after the disclosure of the intervention
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Self-Reported Score of the Nudge's Influence on Decision-Making
Periodo de tiempo: Immediately after the disclosure of the intervention
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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.
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Immediately after the disclosure of the intervention
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Acceptance Score of the Default Option Nudge in Public Health Services
Periodo de tiempo: Immediately after the disclosure of the intervention
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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.
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Immediately after the disclosure of the intervention
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Percentage of Participants Who Accept the Appointment After Disclosure
Periodo de tiempo: Immediately after the disclosure of the intervention
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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.
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Immediately after the disclosure of the intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de abril de 2025
Finalización primaria (Actual)
1 de junio de 2025
Finalización del estudio (Actual)
1 de junio de 2025
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de junio de 2026
Publicado por primera vez (Actual)
2 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Aceptación del paciente de la atención médica
- Neoplasias de Estómago
- Neoplasias Pulmonares
- Cumplimiento del paciente
Otros números de identificación del estudio
- HMUIRB2025029PRE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will be available beginning 6 months and ending 36 months following the publication of the article.
Criterios de acceso compartido de IPD
Researchers who provide a methodologically sound proposal.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .