Project COMFORT

Overview

Key participant information

Participant code
COMFORT-039
Enrollment date
28 Sep 2025
Clinical site
Karolinska Hospital
Enrollment place
Hospital
Enrolled part
B
Status
Completed
Study Population Cohort
Breast cancer
QUESTIONNAIRE
Complete

Study Visits

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

4 visits
DatePartType of visitPlaceStatusComments
28 Sep 2025BScreeningHospitalCompletedScreening visit completed. Eligibility confirmed.
05 Oct 2025B1st VisitNot applicable (N/A)CompletedFollow-up visit completed. Capillary microsampling at home.
26 Oct 2025B2nd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.
16 Nov 2025B3rd VisitHealth Primary CareCompletedAd-hoc follow-up visit.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
05 Oct 2025
B
VenousClinic
Collector
Phlebotomist
Device type
—
Analytes
7
Blood sample collection
26 Oct 2025
B
CapillaryHome
Collector
Nurse
Device type
TAP Micro Select
Analytes
3
Blood sample collection
16 Nov 2025
B
VenousClinic
Collector
Nurse
Device type
—
Analytes
4

Adverse Events

Reported adverse events during the study

No adverse events reported

This participant has no adverse events recorded during the study.

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 2025-10-17

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 knownCapitainer B—
A. Previous Experience with MicrosamplingA3Number of previous uses6-10—
A. Previous Experience with MicrosamplingA4Ease of previous useNeutral—
A. Previous Experience with MicrosamplingA5Previous difficulties experiencedOtherMild pain only.
B. Study Information and Visit ExperienceB1Study information was easy to understandNeutral—
B. Study Information and Visit ExperienceB2I felt comfortable asking questions about the studyDisagree—
B. Study Information and Visit ExperienceB3Satisfaction with study visit organisationVery dissatisfied—
B. Study Information and Visit ExperienceB4Convenience of visit schedulingNeutral—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyDisagree—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitDisagree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedDissatisfied—
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 preferencesAgree—
C. Conventional Sampling vs Microsampling ExperienceC1Pain rating for conventional venous blood sampling (0-10)3—
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 choiceNo preferenceEither option works for me.
C. Conventional Sampling vs Microsampling ExperienceC4Why did you choose this preferred method?Both methods felt similar to me; convenience matters more.—
D. Microsampling Device ExperienceD1The device seemed easy to useDisagree—
D. Microsampling Device ExperienceD2The device caused little or no painStrongly disagree—
D. Microsampling Device ExperienceD3I could use the device at homeStrongly agree—
D. Microsampling Device ExperienceD4Confidence that microsampling could replace conventional blood samplingDisagree—
D. Microsampling Device ExperienceD5Problems experienced with the devicePain, Insufficient bloodSmall leakage on the cartridge.
E. Home / Self-Collection ExperienceE1Did you take part in Part A (home self-collection)?Yes—
E. Home / Self-Collection ExperienceE2Satisfaction with microsampling equipment and materialsVery dissatisfied—
E. Home / Self-Collection ExperienceE3Helpfulness of training materialsUnhelpful—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionDisagree—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearDisagree—
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 agree—
E. Home / Self-Collection ExperienceE8Time required for collecting and returning samples was acceptableStrongly agree—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineStrongly agree—
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?In-person explanation, Telephone/online supportVideo tutorial answered most of my doubts.
F. Training and SupportF2Which factors would build your confidence in using microsampling?Trying the device first with a healthcare professional, Online/telephone support, Tutorial videos—
G. Future PreferencesG1Preferred future blood collection locationNo preference—
G. Future PreferencesG2Willingness to use a microsampling device at home for regular health-related blood samplingMaybeNeed to see results first.
G. Future PreferencesG3If you answered Maybe or No, please explainNot answered—