- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07682220
Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening
26. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1200
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Heilongjiang
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Harbin, Heilongjiang, Čína, 150081
- Harbin Medical University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: 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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Experimentální: 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.
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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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Žádný zásah: 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?"
|
|
|
Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Who Accept the Cancer Screening Appointment
Časové okno: Immediately after the default option intervention
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Participant Attitude Score Towards the Default Option Nudge
Časové okno: 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 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
27. dubna 2025
Primární dokončení (Aktuální)
1. června 2025
Dokončení studie (Aktuální)
1. června 2025
Termíny zápisu do studia
První předloženo
23. června 2026
První předloženo, které splnilo kritéria kontroly kvality
26. června 2026
První zveřejněno (Aktuální)
2. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Nemoci dýchacích cest
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Onemocnění žaludku
- Plicní onemocnění
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Chování
- Dodržování a dodržování léčby
- Zdravotní chování
- Přijímání zdravotní péče pacientem
- Novotvary žaludku
- Novotvary plic
- Compliance pacienta
Další identifikační čísla studie
- HMUIRB2025029PRE
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Časový rámec sdílení IPD
Data will be available beginning 6 months and ending 36 months following the publication of the article.
Kritéria přístupu pro sdílení IPD
Researchers who provide a methodologically sound proposal.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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