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

NCT ID: NCT06351865

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2025-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer; Complication of Surgical Procedure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of East Anglia

OTHER

Sponsor Role: collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward St John

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals NHS Trust

Locations

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Ian Gedge

Role: CONTACT

ian.gedge@porthosp.nhs.uk

02392286000 ext. 5153

Facility Contacts

Edward St John

Role: primary

edward.stjohn@porthosp.nhs.uk

02392286000

Other Identifiers

PHU/2023/21

Identifier Type: -

Identifier Source: org_study_id