TailorDose Lung: Decentralized TDM of Taxanes and ALK Inhibitors Using Capillary Self-Sampling

Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration

Proportion of participants who successfully complete at least one scheduled home capillary self-sampling procedure resulting in a laboratory-approved sample and a reportable drug concentration. Success is defined as completion of all of the following: (1) participant performs the capillary self-collection within the predefined sampling window; (2) the sample is received by the laboratory; (3) the sample meets predefined laboratory suitability criteria, including sufficient sample volume and acceptable sample integrity; and (4) the relevant drug concentration can be successfully quantified using the validated analytical method. The outcome will be reported as the number and percentage of participants meeting all criteria.

Usability and Acceptability of Capillary Self-Sampling

Participant-rated ease of performing capillary self-sampling, assessed using the study-specific patient questionnaire. Participants rate the statement "It was easy to take the blood sample myself" on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater perceived ease of use. Results will be reported as the distribution of responses and/or median and interquartile range. Participant acceptability of decentralized capillary self-sampling, assessed using the study-specific patient questionnaire on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater acceptability. The predefined acceptability item will assess willingness to use home capillary self-sampling as part of future cancer care.

Need for Assistance With Capillary Self-Sampling

Proportion of participants who require assistance or report difficulty when using the capillary self-sampling system. This outcome will assess whether the training materials and instructions are sufficient to support participants in performing the sampling procedure.

Laboratory Sample Suitability

Number and proportion of returned capillary blood samples meeting all predefined laboratory suitability criteria for drug concentration analysis. A sample will be classified as suitable when sufficient sample volume is available, sample integrity is acceptable, and the sample can proceed to quantitative analysis according to the predefined laboratory procedures. The denominator will be all capillary samples received by the laboratory.

Barriers and Facilitators to Implementation of Capillary Self-Sampling

Barriers and facilitators to implementation of patient-centric microsampling will be explored through semi-structured focus groups and/or interviews with patients and healthcare professionals. The evaluation will address uptake and adherence, trust, usability and acceptability, training needs, effects on clinical workflow and communication, and patient autonomy. Interviews will be audio-recorded, transcribed verbatim, and analyzed using qualitative content analysis.

Capillary Blood Concentration of Docetaxel

Docetaxel concentration measured in capillary blood at predefined sampling time points using the validated quantitative analytical method. Concentrations will be reported in ng/mL.

Capillary Blood Concentration of Paclitaxel

Paclitaxel concentration measured in capillary blood at predefined sampling time points using the validated quantitative analytical method. Concentrations will be reported in ng/mL.

Capillary Blood Trough Concentration (Cmin) of Alectinib

lectinib trough concentration (Cmin) measured in capillary blood at the predefined steady-state sampling time point. Concentrations will be reported in ng/mL.

Capillary Blood Trough Concentration (Cmin) of Lorlatinib

Lorlatinib trough concentration (Cmin) measured in capillary blood at the predefined steady-state sampling time point. Concentrations will be reported in ng/mL.