- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07682220
Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening
26 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1200
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Heilongjiang
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Harbin, Heilongjiang, Chiny, 150081
- Harbin Medical University
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: 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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Eksperymentalny: 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.
|
|
Brak interwencji: 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?"
|
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants Who Accept the Cancer Screening Appointment
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Participant Attitude Score Towards the Default Option Nudge
Ramy czasowe: 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
|
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Self-Reported Score of the Nudge's Influence on Decision-Making
Ramy czasowe: 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.
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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
Ramy czasowe: 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.
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Immediately after the disclosure of the intervention
|
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Percentage of Participants Who Accept the Appointment After Disclosure
Ramy czasowe: 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.
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Immediately after the disclosure of the intervention
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
27 kwietnia 2025
Zakończenie podstawowe (Rzeczywisty)
1 czerwca 2025
Ukończenie studiów (Rzeczywisty)
1 czerwca 2025
Daty rejestracji na studia
Pierwszy przesłany
23 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
2 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
26 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby Układu Oddechowego
- Nowotwory przewodu pokarmowego
- Nowotwory Układu Pokarmowego
- Choroby Układu Pokarmowego
- Choroby przewodu pokarmowego
- Choroby żołądka
- Choroby płuc
- Nowotwory Układu Oddechowego
- Nowotwory klatki piersiowej
- Zachowanie
- Przestrzeganie i przestrzeganie zaleceń dotyczących leczenia
- Zachowanie zdrowotne
- Akceptacja opieki zdrowotnej przez pacjentów
- Nowotwory żołądka
- Nowotwory płuc
- Zdyscyplinowanie pacjenta
Inne numery identyfikacyjne badania
- HMUIRB2025029PRE
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania IPD
Data will be available beginning 6 months and ending 36 months following the publication of the article.
Kryteria dostępu do udostępniania IPD
Researchers who provide a methodologically sound proposal.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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