Project COMFORT

Overview

Key participant information

Participant code
COMFORT-001
Enrollment date
02 Sep 2025
Clinical site
Vall d’Hebron
Enrollment place
Hospital
Enrolled part
AB
Status
Completed
Study Population Cohort
Colorectal cancer
QUESTIONNAIRE
Complete

Study Visits

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

6 visits
DatePartType of visitPlaceStatusComments
02 Sep 2025AScreeningHospitalCompletedScreening visit completed. Eligibility confirmed.
09 Sep 2025A1st VisitHospitalCompletedBaseline visit completed. Sample collection performed at clinical site.
30 Sep 2025A2nd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.
21 Oct 2025A3rd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.
11 Nov 2025B1st VisitNot applicable (N/A)CompletedFollow-up visit completed. Capillary microsampling at home.
02 Dec 2025B2nd VisitHospitalCompletedAd-hoc follow-up visit.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
09 Sep 2025
A
VenousClinic
Collector
Participant
Device type
—
Analytes
6
Blood sample collection
30 Sep 2025
A
VenousClinic
Collector
Phlebotomist
Device type
—
Analytes
5
Blood sample collection
21 Oct 2025
A
CapillaryClinic
Collector
Participant
Device type
Greiner MiniCollect EDTA
Analytes
6
Blood sample collection
11 Nov 2025
B
VenousClinic
Collector
Participant
Device type
—
Analytes
5
Blood sample collection
02 Dec 2025
B
CapillaryHome
Collector
Phlebotomist
Device type
Capitainer B
Analytes
3

Adverse Events

Reported adverse events during the study

DatePartVisitSeverityDevice relatedAction
21 Sep 2025ANot applicableModerateConfirmed

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 2025-10-13

Complete
SECTIONQ #QuestionAnswerComments / Free-text
A. Previous Experience with MicrosamplingA1Had you heard about blood microsampling before this study?Yes—
A. Previous Experience with MicrosamplingA2Name of the microsampling device previously knownNot answered—
A. Previous Experience with MicrosamplingA3Number of previous uses1-2—
A. Previous Experience with MicrosamplingA4Ease of previous useNeutral—
A. Previous Experience with MicrosamplingA5Previous difficulties experiencedNot answered—
B. Study Information and Visit ExperienceB1Study information was easy to understandNot answered—
B. Study Information and Visit ExperienceB2I felt comfortable asking questions about the studyDisagree—
B. Study Information and Visit ExperienceB3Satisfaction with study visit organisationDissatisfied—
B. Study Information and Visit ExperienceB4Convenience of visit schedulingSatisfied—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyAgree—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitStrongly disagree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedSatisfied—
B. Study Information and Visit ExperienceB8Visit duration was acceptableDisagree—
B. Study Information and Visit ExperienceB9Impact on daily life was acceptableDisagree—
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)5—
C. Conventional Sampling vs Microsampling ExperienceC2Pain rating for microsampling device collection (0-10)1—
C. Conventional Sampling vs Microsampling ExperienceC3Preferred blood collection method if given a choiceConventional blood sampling—
C. Conventional Sampling vs Microsampling ExperienceC4Why did you choose this preferred method?I am used to venous sampling and trust the technique more.—
D. Microsampling Device ExperienceD1The device seemed easy to useNeutral—
D. Microsampling Device ExperienceD2The device caused little or no painStrongly agree—
D. Microsampling Device ExperienceD3I could use the device at homeStrongly disagree—
D. Microsampling Device ExperienceD4Confidence that microsampling could replace conventional blood samplingNot answered—
D. Microsampling Device ExperienceD5Problems experienced with the deviceDevice error, Other—
E. Home / Self-Collection ExperienceE1Did you take part in Part A (home self-collection)?No—
E. Home / Self-Collection ExperienceE2Satisfaction with microsampling equipment and materialsVery dissatisfied—
E. Home / Self-Collection ExperienceE3Helpfulness of training materialsHelpful—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionDisagree—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearStrongly disagree—
E. Home / Self-Collection ExperienceE6I was able to complete sample collection without helpStrongly agree—
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 acceptableStrongly agree—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineAgree—
E. Home / Self-Collection ExperienceE10I felt safe and confident during self-collectionDisagree—
E. Home / Self-Collection ExperienceE11Satisfaction with shipping samples back to the labVery satisfied—
F. Training and SupportF1Which support types were helpful?Other, Video tutorial, Printed instructions—
F. Training and SupportF2Which factors would build your confidence in using microsampling?Doctor recommendation—
G. Future PreferencesG1Preferred future blood collection locationAt home—
G. Future PreferencesG2Willingness to use a microsampling device at home for regular health-related blood samplingMaybeWould prefer if I had ongoing support.
G. Future PreferencesG3If you answered Maybe or No, please explainNot answered—