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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Weijia Fang, M.D.
- 電話番号:86-057187237587
- メール:weijiafang@zju.edu.cn
研究連絡先のバックアップ
- 名前:Yang Gao, M.D.
- メール:gaoyang954@zju.edu.cn
研究場所
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- 募集
- The First Affiliated Hospital, Zhejiang University School of Medicine
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コンタクト:
- Yang Gao, M.D.
- 電話番号:86-057187237587
- メール:gaoyang954@zju.edu.cn
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主任研究者:
- Weijia Fang, M.D.
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part-worth utility coefficients (preference weights) for cell therapy benefit-risk attributes
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in preference weights for cell therapy benefit-risk attributes between patients and physicians
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CellChoice-DCE-V1.0
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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