Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)
Conditions
Keywords
Therapeutic drug monitoring, Patient-centric microsampling, Capillary self-sampling, Precision dosing, Docetaxel, Alectinib, Lorlatinib, ALK inhibitors, Taxanes, Paclitaxel, Feasiblity reserach, Implementation research
Brief summary
This study will evaluate whether people with non-small cell lung cancer (NSCLC) can collect small blood samples themselves using a finger-prick sampling kit. Participants will be receiving standard treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. The blood samples will be used to measure the amount of cancer medicine in the blood. Most samples will be collected by participants at home and returned to a laboratory for analysis. The study will assess how easy the sampling method is to use, whether the collected samples are suitable for laboratory analysis, and how patients and healthcare professionals experience this way of collecting blood samples. The study will also explore whether measured drug levels are related to side effects, dose changes, treatment delays, or other clinical outcomes. The drug-level results collected in this study will be used for research purposes and will not be used to change participants' cancer treatment. About 80 participants will take part in the study and will be followed for approximately 3 months. The microsampling device is CE-marked and used within its approved use exclusively for research and feasibility evaluation. Study results do not influence ongoing clinical treatment decisions. This study is being conducted as part of Project-COMFORT, a European multi-country initiative aiming to evaluate the feasibility and implementation of PCmS across various populations and healthcare systems.
Detailed description
This prospective, non-interventional feasibility and implementation study evaluates decentralized therapeutic drug monitoring (TDM) using capillary self-sampling in adults with non-small cell lung cancer (NSCLC) receiving standard-of-care treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. The study focuses on the feasibility, usability, and implementation of patient-centric microsampling in routine oncology care. Participants will be trained to collect a small capillary whole-blood sample using a finger prick. Samples will be collected mainly at home and returned by mail for laboratory analysis. Sampling schedules are adapted to the treatment received. For participants receiving taxanes, capillary samples are collected at defined time points after infusion. For participants receiving ALK inhibitors, samples are collected at home in relation to the scheduled oral dose. The primary focus of the study is whether participants can successfully perform capillary self-sampling and whether the returned samples are suitable for laboratory analysis. Participant experience, usability, need for assistance, and practical aspects of integrating home-based sampling into oncology care will also be evaluated. Qualitative interviews or focus groups with patients and healthcare professionals will explore barriers and facilitators to implementation and the potential impact of decentralized sampling on clinical workflows. Drug concentrations will be measured for research purposes. Exploratory analyses will examine associations between drug exposure and clinical measures such as treatment-related toxicity, dose modifications or delays, hospital visits, and clinical response when available. In participants with both capillary and venous samples, the relationship between concentrations measured using the two sampling methods may also be evaluated. Participants will continue to receive their prescribed cancer treatment according to standard clinical practice. The study does not introduce an investigational medicinal product, randomize participants, or require treatment changes based on study measurements. Drug concentration results obtained through capillary self-sampling will not be used to guide treatment decisions during the study.
Interventions
DEVICETrue Dose® Capillary Self-Sampling System
The True Dose® capillary self-sampling system is a patient-centric microsampling system that enables collection of approximately 50 µL of capillary whole blood using a finger prick. Participants are trained to perform capillary blood collection, primarily at home, and samples are returned by mail for laboratory analysis of drug concentrations. The study evaluates the feasibility, usability, and sample suitability of decentralized capillary self-sampling for therapeutic drug monitoring. Results from study-specific drug concentration measurements will be used for research purposes and will not be used to guide participants' cancer treatment.
Sponsors
Karolinska Institutet
Project-COMFORT
Stockholm School of Economics Institute for Research (SIR)
ALK Positive Sverige, Sweden
True Dose AB
Vinnova
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are included in one of two parallel cohorts according to their ongoing standard-of-care cancer treatment: taxane therapy (docetaxel or paclitaxel) or ALK inhibitor therapy (alectinib or lorlatinib). Treatment is not assigned by the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥18 years. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Receiving ongoing standard-of-care treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. Able to understand Swedish or English and provide written informed consent. Willing and able to comply with study-required procedures, including blood sample collection. Able to perform capillary self-sampling at home, with or without support from a caregiver or healthcare professional. Access to a stable home or remote environment suitable for sample collection and, where applicable, home nurse visits. Able to participate in the required sample collection and shipping procedures, independently or with support from a family member or caregiver.
Exclusion criteria
Concurrent participation in another interventional study that may affect pharmacokinetics. Severe coagulopathy or another contraindication to capillary blood sampling. Known hypersensitivity to a previously used adhesion system used for sample collection. Any condition that, in the investigator's judgment, would make study participation unsafe or infeasible, including skin infection or another skin condition at the intended sample collection site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration | From first scheduled home sampling until completion of the sampling period, approximately 1 month. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability and Acceptability of Capillary Self-Sampling | Through study completion, approximately 3 months | 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 | Through study completion, approximately 3 months | 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 | Through study completion, approximately 3 months | 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 | Through study completion, approximately 3 months | 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. |
Countries
Sweden
Contacts
CONTACTElin Backman Stålnacke, Speciliased Nurse in Oncology
CONTACTElham Hedayati, MD PhD
PRINCIPAL_INVESTIGATORSimon Ekman, Professor, MD, PhD
Karolinska Institutet
Outcome results
None listed