- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07682220
Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening
26. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Harbin Medical University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: 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?"
|
|
|
Eksperimentell: 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.
|
|
Ingen inngripen: 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?"
|
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Who Accept the Cancer Screening Appointment
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Participant Attitude Score Towards the Default Option Nudge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. april 2025
Primær fullføring (Faktiske)
1. juni 2025
Studiet fullført (Faktiske)
1. juni 2025
Datoer for studieregistrering
Først innsendt
23. juni 2026
Først innsendt som oppfylte QC-kriteriene
26. juni 2026
Først lagt ut (Faktiske)
2. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Oppførsel
- Behandlingsoverholdelse og etterlevelse
- Helseatferd
- Pasientens aksept av helsehjelp
- Neoplasmer i magen
- Lungeneoplasmer
- Pasientens etterlevelse
Andre studie-ID-numre
- HMUIRB2025029PRE
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Data will be available beginning 6 months and ending 36 months following the publication of the article.
Tilgangskriterier for IPD-deling
Researchers who provide a methodologically sound proposal.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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