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Preoperative Decision-Making in Patients With Pulmonary Nodules Suspected of Lung Cancer

14 maja 2026 zaktualizowane przez: Xing Wei, MD, Sichuan Cancer Hospital and Research Institute

Preoperative Decision-Making Characteristics and Associated Mechanisms in Patients With Pulmonary Nodules Suspected of Lung Cancer

Patients with pulmonary nodules that are highly suspected to be lung cancer often need to make important treatment decisions before a definite pathological diagnosis is available. These decisions may include whether to undergo surgery, whether to continue follow-up, whether to have further diagnostic tests, and how to understand the potential benefits and risks of different management options.

This prospective observational study aims to describe the preoperative decision-making status of adult patients with pulmonary nodules suspected of lung cancer. The study will assess patients' decision self-efficacy, decisional conflict, shared decision-making experience, and decision regret using standardized questionnaires. It will also explore factors associated with better or worse decision quality, such as demographic characteristics, clinical information, health literacy, doctor-patient communication, family involvement, and emotional status.

No treatment or intervention will be assigned by the study. Participants will receive routine clinical care, and study data will be collected mainly through questionnaires before surgery or during the preoperative period. The findings may help clinicians identify patients who need additional decision support and improve communication during preoperative decision-making for suspected lung cancer.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Pulmonary nodules that are highly suspected of malignancy represent a common and clinically challenging scenario in thoracic surgery. Before a definite pathological diagnosis is available, patients may need to make complex decisions regarding surgery, additional diagnostic procedures, active surveillance, or other management strategies. These decisions are often made under uncertainty and may be influenced by patients' understanding of medical information, perceived cancer risk, fear of treatment delay, concerns about unnecessary surgery, family involvement, and communication with clinicians.

This is a single-center, prospective observational study conducted at Sichuan Cancer Hospital. The study plans to enroll approximately 200 adult patients with pulmonary nodules highly suspected of lung cancer who are facing preoperative clinical decision-making. The study will not assign any treatment, diagnostic procedure, or behavioral intervention. All clinical management decisions will be made according to routine clinical practice and shared discussion between patients and their treating clinicians.

The primary aim of the study is to characterize preoperative decision-making among patients with pulmonary nodules suspected of lung cancer. Specifically, the study will assess decision self-efficacy, decisional conflict, and decision quality. Decision self-efficacy will be evaluated using the Decision Self-Efficacy Scale. Decisional conflict will be assessed using the Decisional Conflict Scale. Decision quality and shared decision-making experience will be evaluated using instruments such as the SDM-Q-9 and decision regret-related measures, as applicable.

The study will also explore the relationships among decision self-efficacy, decisional conflict, and decision quality. Potential associated factors may include demographic characteristics, clinical characteristics, health literacy, quality of doctor-patient communication, family involvement, emotional status, and patient preferences. Data will be collected using structured questionnaires during the preoperative outpatient or inpatient period.

Descriptive statistics will be used to summarize participant characteristics and questionnaire scores. Correlation analyses, multivariable regression models, and, if appropriate, structural equation modeling will be used to examine the associations and potential pathways linking decision self-efficacy, decisional conflict, and decision quality. The study is expected to provide evidence for identifying patients at risk of poor decision quality and for developing future decision support strategies in thoracic surgical practice.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

200

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Chiny
    • Sichuan
      • Chengdu, Sichuan, Chiny, 610041
        • Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China
        • Kontakt:
        • Główny śledczy:
          • Xing Wei, MD

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

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The study population will include adult patients treated at Sichuan Cancer Hospital who have pulmonary nodules highly suspected of lung cancer before pathological confirmation and who are facing preoperative clinical decision-making. Eligible participants will be identified from thoracic surgery outpatient clinics and inpatient wards. Participants will receive routine clinical care, and study data will be collected using structured questionnaires during the preoperative period.

Opis

Inclusion Criteria:

  1. Age 18 years or older.
  2. Adult patients with pulmonary nodules that are highly suspected of malignancy based on clinical and radiological assessment.
  3. No definite pathological diagnosis of lung cancer before enrollment.
  4. Patients who are facing preoperative clinical decision-making with more than one reasonable management option, such as surgery, additional diagnostic evaluation, or follow-up.
  5. Able to understand the study procedures and complete the study questionnaires.
  6. Able and willing to provide written informed consent.

Exclusion Criteria:

  1. Patients without a real clinical decision-making choice regarding the management of the pulmonary nodule.
  2. Patients with severe cognitive impairment or a history of severe psychiatric disease that would interfere with valid questionnaire completion.
  3. Patients who are unable to communicate effectively with the study staff.
  4. Patients who decline to participate or are unable to provide written informed consent.

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

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Patients With Pulmonary Nodules Suspected of Lung Cancer
Adult patients with pulmonary nodules highly suspected of lung cancer who are facing preoperative clinical decision-making before pathological confirmation. Participants will receive routine clinical care. No intervention, treatment assignment, or diagnostic procedure will be assigned by the study. Study data will be collected using structured questionnaires to assess decision self-efficacy, decisional conflict, shared decision-making experience, decision regret, and related clinical and demographic factors.
Inny: Questionnaire-Based Decision-Making Assessment
Participants will complete structured questionnaires during the preoperative outpatient or inpatient period. The questionnaires will assess decision self-efficacy, decisional conflict, shared decision-making experience, decision regret, and related demographic and clinical factors. The study will not assign any treatment, diagnostic procedure, surgery, or decision-support intervention. All clinical care and management decisions will follow routine practice.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Decisional Conflict Scale Score
Ramy czasowe: At enrollment during the preoperative period, before surgery
Decisional conflict will be assessed using the Decisional Conflict Scale. The scale evaluates uncertainty in decision-making, feeling uninformed, unclear personal values, inadequate support, and perceived ineffective decision-making. The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict. A score of 37.5 or higher indicates clinically important decisional conflict.
At enrollment during the preoperative period, before surgery

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Decision Self-Efficacy Scale Score
Ramy czasowe: At enrollment during the preoperative period, before surgery
Decision self-efficacy will be assessed using the Decision Self-Efficacy Scale. The scale measures participants' confidence in obtaining information, understanding risks and benefits, clarifying personal values, expressing preferences, and making healthcare decisions. The total score ranges from 0 to 100, with higher scores indicating greater decision self-efficacy.
At enrollment during the preoperative period, before surgery
Shared Decision-Making Questionnaire-9 Score
Ramy czasowe: After preoperative clinical consultation and before surgery
The shared decision-making experience will be assessed using the 9-item Shared Decision-Making Questionnaire. The questionnaire evaluates the participant's perception of involvement in the clinical decision-making process. The total score will be transformed to a 0-to-100 scale, with higher scores indicating a better shared decision-making experience.
After preoperative clinical consultation and before surgery
Decision Regret Scale Score
Ramy czasowe: 1 month after the preoperative clinical decision
Decision regret will be assessed using the Decision Regret Scale. The scale measures distress or remorse after a healthcare decision has been made. The total score ranges from 0 to 100, with higher scores indicating greater decision regret.
1 month after the preoperative clinical decision

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Sichuan Cancer Hospital and Research Institute

Śledczy

  • Główny śledczy: Xing Wei, MD, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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 (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2027

Ukończenie studiów (Szacowany)

31 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

10 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • CN-SDM-Lung 2

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be publicly shared because the study collects sensitive clinical and decision-making information from patients before pathological confirmation. De-identified aggregate results may be reported in publications or conference presentations. Requests for de-identified data may be considered by the principal investigator and the ethics committee, subject to applicable institutional policies and participant consent.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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