- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07813000
Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors
Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors: A Discrete Choice Experiment
Cell therapies - including chimeric antigen receptor T-cell (CAR-T) therapy, tumor-infiltrating lymphocyte (TIL) therapy, T-cell receptor-engineered T-cell (TCR-T) therapy, and natural killer (NK) cell therapy - are emerging treatments for advanced solid tumors. However, their benefit-risk profiles remain uncertain: objective response rates in solid tumors are generally low, treatment-related toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) can be severe, and the manufacturing process is lengthy and costly. Little is known about how physicians and patients weigh these benefits, risks, and burdens when considering cell therapy for advanced solid tumors.
This cross-sectional, survey-based observational study will use a discrete choice experiment (DCE) to quantify and compare treatment preferences among approximately 420 oncology physicians and 600 patients with advanced solid tumors in China. Each participant will complete a one-time online questionnaire containing a series of hypothetical treatment choices. The study will estimate the relative importance of key treatment attributes (efficacy, safety, treatment burden, and cost), the maximum acceptable risk that participants are willing to tolerate in exchange for improved efficacy, and differences in preferences between physicians and patients. The findings will inform shared decision-making, cell therapy development, regulatory benefit-risk assessment, and health policy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Weijia Fang, M.D.
- Numéro de téléphone: 86-057187237587
- E-mail: weijiafang@zju.edu.cn
Sauvegarde des contacts de l'étude
- Nom: Yang Gao, M.D.
- E-mail: gaoyang954@zju.edu.cn
Lieux d'étude
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310000
- Recrutement
- The First Affiliated Hospital, Zhejiang University School of Medicine
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Contact:
- Yang Gao, M.D.
- Numéro de téléphone: 86-057187237587
- E-mail: gaoyang954@zju.edu.cn
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Chercheur principal:
- Weijia Fang, M.D.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Physicians
Physicians must meet ALL of the following criteria:
- Hold a valid medical practitioner license issued in the People's Republic of China and currently practice at a medical institution in China;
- Specialize in medical oncology or another specialty directly involved in the diagnosis and treatment of solid tumors (e.g., thoracic oncology, gastrointestinal oncology, genitourinary oncology, or gynecologic oncology; surgical oncologists or radiation oncologists with prescribing authority for systemic anticancer therapy are also eligible);
- Hold a professional title of attending physician or above;
- Have directly participated in systemic treatment decision-making for patients with advanced (unresectable stage III or stage IV) solid tumors within the past 12 months;
- Have a basic understanding of cell therapies (e.g., CAR-T, TIL, TCR-T, and NK cell therapies) and their therapeutic principles;
Participate voluntarily and provide electronic informed consent.
- Patients
Patients must meet ALL of the following criteria:
- Aged 18 years or older;
- Histologically or cytologically confirmed advanced solid tumor (unresectable stage III or stage IV; e.g., non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, gastric cancer, melanoma, or ovarian cancer);
- Received at least one prior line of systemic anticancer therapy (chemotherapy, targeted therapy, immune checkpoint inhibitors, or other cellular immunotherapy) in the advanced or metastatic setting;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with adequate cognitive and physical capacity to complete the questionnaire;
- Able to understand the questionnaire content independently or with assistance from a study coordinator;
- Participate voluntarily and provide electronic informed consent.
Exclusion Criteria:
- Physicians
Physicians meeting ANY of the following criteria will be excluded:
- Individuals engaged exclusively in basic research without direct involvement in clinical patient care;
Individuals unable, for any reason, to understand the questionnaire content or make independent judgments.
- Patients
Patients meeting ANY of the following criteria will be excluded:
- Patients who are unaware of their tumor stage or treatment status;
- Severe cognitive impairment or psychiatric disorders that preclude comprehension of the questionnaire content or independent judgment;
- Estimated life expectancy of less than 3 months as assessed by the treating physician, or insufficient physical capacity to complete the questionnaire;
- Uncontrolled acute illness or other urgent medical conditions that make study participation inadvisable.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Cohort 1: Physicians
Licensed oncology physicians who have participated in systemic treatment decision-making for patients with advanced solid tumors within the past 12 months (approximately 420 participants).
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This is an observational study.
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Cohort 2: Patients
Adults with histologically or cytologically confirmed advanced solid tumors (unresectable stage III or stage IV) who have received at least one prior line of systemic anticancer therapy (approximately 600 participants).
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This is an observational study.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Part-worth utility coefficients (preference weights) for cell therapy benefit-risk attributes
Délai: Day 1
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Preference weights (part-worth utility coefficients) for all attribute levels will be estimated using a random-parameters logit (mixed logit) model, fitted separately in the physician and patient cohorts.
Each coefficient represents the marginal change in utility associated with moving from the reference level to a given attribute level.
The unit of measure is the preference weight, reported with 95% confidence intervals; within an attribute, a higher weight indicates a more preferred level.
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Day 1
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference in preference weights for cell therapy benefit-risk attributes between patients and physicians
Délai: Day 1
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Between-group differences in preference weights will be evaluated using the Swait-Louviere scale parameter test, a chi-square test of whether the two groups' choice data can be pooled into a single model, accounting for differences in scale (error variance) between groups.
The unit of measure is the chi-square test statistic.
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Day 1
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Maximum acceptable risk (MAR) of treatment-related adverse events in exchange for improved efficacy
Délai: Day 1
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Maximum acceptable risk (MAR) is the maximum acceptable percentage-point increase in a treatment-related risk that participants are willing to tolerate in exchange for a defined improvement in efficacy.
MAR will be calculated from the estimated preference weights as the negative of the ratio between the marginal utility of the efficacy improvement and the marginal disutility of the risk increase from the lowest level of that risk included in the DCE.
The unit of measure is percentage points of treatment-related risk.
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Day 1
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Marginal willingness to pay (mWTP) for improvements in cell therapy attributes
Délai: Day 1
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Marginal willingness to pay (mWTP) will be calculated as the negative ratio of the preference weight of a non-cost attribute level to the coefficient of the cost attribute.
The unit of measure is Chinese yuan (CNY), representing the additional out-of-pocket expense participants are willing to pay for a given attribute level relative to its reference level.
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Day 1
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CellChoice-DCE-V1.0
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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