Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent

Sponsor: Portsmouth Hospitals NHS Trust

NCT ID: NCT06351865

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
Mix of remote tasks and in-person visits
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
Female
Number of participants
50
Started
2024-03-07
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • Clinical study - 50 participants
  • • Patient report complication data to our best knowledge has not been studied yet in electronic consent

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer
  • • Female only

Where?

  • • Portsmouth - Queen Alexandra Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems.

More detail

At the time of consent, patients are informed of possible post-operative complications. It is often not known whether these complications actually occur, whether there are others which go unreported and the extent, both quantitatively and qualitatively, of the complications. Patient reported complication data, to our best knowledge has not been previously studied. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. In this case, consent is to be sought digitally; the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience. If PRC data collection is feasible and reliable, this technique could be scaled to create a consent feedback loop, enabling operative outcome data to be collected from all patients, to be be used to improve the consent process for subsequent patients. Awareness of post-operative patient complications is important and it is an NHS (National Health Service) requirement that complications are discussed within regular clinical governance (mortality/morbidity) audit departmental meetings. Currently this process relies on clinicians obtaining and reporting these complications. The move towards Patient Initiated Follow Up (PIFU) models may be leading to underreporting of problems. Potentially Patient Reported Complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures. This in turn might help facilitate 'shared decision making' and allow treatment decisions to be tailored to the individual patients.

Breast CancerComplication of Surgical Procedure

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

What the study is looking for

  • ✓Consent form 1- Adult patients who have the capacity to consent for themselves.
  • ✓Female adult aged 18years or above
  • ✓Diagnosed with early invasive breast cancer suitable for breast conserving surgery
  • ✓Undergoing Wide Local Excision of the breast and sentinel lymph node biopsy.
  • ✓Participant must be able to fill out an electronic questionnaire or take part in a phone questionnaire.

Who cannot take part

  • ✗Unable to consent for themselves or do not wish to participate.
  • ✗Patients who need an interpreter.
See the full criteria
Inclusion Criteria: * Consent form 1- Adult patients who have the capacity to consent for themselves. * Female adult aged 18years or above * Diagnosed with early invasive breast cancer suitable for breast conserving surgery * Undergoing Wide Local Excision of the breast and sentinel lymph node biopsy. * Participant must be able to fill out an electronic questionnaire or take part in a phone questionnaire. * Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: * Unable to consent for themselves or do not wish to participate. * Patients who need an interpreter.

Where Is This Study? (1 UK site)

Queen Alexandra Hospital

Portsmouth PO6 3LY, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Ian Gedge

Sponsor contact

CONTACT

02392286000 ian.gedge@porthosp.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-09