Health TrialsbyHealthPanel

Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors

ConditionSolid Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physicians

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;

Disqualifiers

Physicians

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

Trial population

Approximately 420 licensed oncology physicians and 600 adult patients with advanced solid tumors will be enrolled in China.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Not applicable- observational study

    Other intervention

    This is an observational study.

Treatment groups

1,020 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Physicians1 intervention
Group B: Cohort 2: Patients1 intervention

Trial outcomes

Primary outcomes

1

Part-worth utility coefficients (preference weights) for cell therapy benefit-risk attributes

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.

Time frame
Day 1

Secondary outcomes

1

Difference in preference weights for cell therapy benefit-risk attributes between patients and physicians

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.

Time frame
Day 1
2

Maximum acceptable risk (MAR) of treatment-related adverse events in exchange for improved efficacy

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.

Time frame
Day 1
3

Marginal willingness to pay (mWTP) for improvements in cell therapy attributes

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.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
Apply now