Project COMFORT

Overview

Key participant information

Participant code
COMFORT-019
Enrollment date
22 Sep 2025
Clinical site
Vall d’Hebron
Enrollment place
Hospital
Enrolled part
AB
Status
Completed
Study Population Cohort
Prostate cancer
QUESTIONNAIRE
Complete

Study Visits

Details of participatnt visits in Part A and/or Part B

6 visits
DatePartType of visitPlaceStatusComments
22 Sep 2025AScreeningHospitalCompletedScreening visit completed. Eligibility confirmed.
29 Sep 2025A1st VisitHospitalCompletedBaseline visit completed. Sample collection performed at clinical site.
20 Oct 2025A2nd VisitHealth Primary CareCompletedAd-hoc follow-up visit.
10 Nov 2025B1st VisitNot applicable (N/A)CompletedFollow-up visit completed. Capillary microsampling at home.
01 Dec 2025B2nd VisitHealth Primary CareCompletedAd-hoc follow-up visit.
22 Dec 2025B3rd VisitHealth Primary CareCompletedAd-hoc follow-up visit.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
29 Sep 2025
A
VenousClinic
Collector
Caregiver
Device type
—
Analytes
5
Blood sample collection
20 Oct 2025
A
CapillaryClinic
Collector
Participant
Device type
Greiner MiniCollect EDTA
Analytes
5
Blood sample collection
10 Nov 2025
B
CapillaryClinic
Collector
Caregiver
Device type
TAP Micro Select
Analytes
3
Blood sample collection
01 Dec 2025
B
CapillaryClinic
Collector
Caregiver
Device type
Greiner MiniCollect EDTA
Analytes
7
Blood sample collection
22 Dec 2025
B
VenousClinic
Collector
Nurse
Device type
—
Analytes
6

Adverse Events

Reported adverse events during the study

DatePartVisitSeverityDevice relatedAction
20 Oct 2025BVisit 3MildNo

Medical profile

Past medical history and conditions

Coming soon

Past medical history, conditions, medications and allergies will appear here once the ETL feed is connected.

Usability Questionnaire

Participant responses — surveyed on 2025-10-06

Complete
SECTIONQ #QuestionAnswerComments / Free-text
A. Previous Experience with MicrosamplingA1Had you heard about blood microsampling before this study?No—
A. Previous Experience with MicrosamplingA2Name of the microsampling device previously knownNot answered—
A. Previous Experience with MicrosamplingA3Number of previous usesNot answered—
A. Previous Experience with MicrosamplingA4Ease of previous useNot answered—
A. Previous Experience with MicrosamplingA5Previous difficulties experiencedNot answered—
B. Study Information and Visit ExperienceB1Study information was easy to understandStrongly disagree—
B. Study Information and Visit ExperienceB2I felt comfortable asking questions about the studyDisagree—
B. Study Information and Visit ExperienceB3Satisfaction with study visit organisationVery satisfied—
B. Study Information and Visit ExperienceB4Convenience of visit schedulingNot answered—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyStrongly disagree—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitAgree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedDissatisfied—
B. Study Information and Visit ExperienceB8Visit duration was acceptableNeutral—
B. Study Information and Visit ExperienceB9Impact on daily life was acceptableAgree—
B. Study Information and Visit ExperienceB10I felt comfortable providing feedback on sampling preferencesStrongly disagree—
C. Conventional Sampling vs Microsampling ExperienceC1Pain rating for conventional venous blood sampling (0-10)9—
C. Conventional Sampling vs Microsampling ExperienceC2Pain rating for microsampling device collection (0-10)7—
C. Conventional Sampling vs Microsampling ExperienceC3Preferred blood collection method if given a choiceConventional blood samplingMicrosampling felt much less invasive.
C. Conventional Sampling vs Microsampling ExperienceC4Why did you choose this preferred method?Microsampling caused noticeably less discomfort and was faster to perform.—
D. Microsampling Device ExperienceD1The device seemed easy to useStrongly disagree—
D. Microsampling Device ExperienceD2The device caused little or no painStrongly agree—
D. Microsampling Device ExperienceD3I could use the device at homeAgree—
D. Microsampling Device ExperienceD4Confidence that microsampling could replace conventional blood samplingStrongly agree—
D. Microsampling Device ExperienceD5Problems experienced with the devicePain—
E. Home / Self-Collection ExperienceE1Did you take part in Part A (home self-collection)?Yes—
E. Home / Self-Collection ExperienceE2Satisfaction with microsampling equipment and materialsNot answered—
E. Home / Self-Collection ExperienceE3Helpfulness of training materialsNeutral—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionDisagree—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearNeutral—
E. Home / Self-Collection ExperienceE6I was able to complete sample collection without helpStrongly disagree—
E. Home / Self-Collection ExperienceE7I had access to support during self-collectionStrongly disagree—
E. Home / Self-Collection ExperienceE8Time required for collecting and returning samples was acceptableDisagree—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineAgree—
E. Home / Self-Collection ExperienceE10I felt safe and confident during self-collectionStrongly disagree—
E. Home / Self-Collection ExperienceE11Satisfaction with shipping samples back to the labNeutral—
F. Training and SupportF1Which support types were helpful?Printed instructions, In-person explanation, Video tutorialVideo tutorial answered most of my doubts.
F. Training and SupportF2Which factors would build your confidence in using microsampling?Tutorial videos, Doctor recommendation, Trying the device first with a healthcare professional—
G. Future PreferencesG1Preferred future blood collection locationAt home—
G. Future PreferencesG2Willingness to use a microsampling device at home for regular health-related blood samplingNot answered—
G. Future PreferencesG3If you answered Maybe or No, please explainConcerned about correctly handling the sample at home.—