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

NCT06351865 | Recruiting

• 1 other identifier: PHU/2023/21
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Complication of Surgical Procedure

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who respond to the feedback questionnaire

  Calculate the proportion of patients who respond to the feedback questionnaire

  6 months

• Final attrition rate

  Calculate the final attrition rate. This is the proportion of patients who fail to respond to the email questionnaire and telephone call.

  6 months

Secondary Outcomes (6)

• Quoted risks in the consent to the incidence of complications

  6 months

• Frequency of PRC and CRCs (Consent Form Reported Complications)

  6 months

• Understanding of consent

  6 months

• Language used in patient reported complications

  6 months

• Accuracy of potential complications

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over 18yrs old with early invasive breast cancer who are undergoing "wide local excision and sentinel lymph node biopsy" operation.

You may qualify if:

• 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.

You may not qualify if:

• Unable to consent for themselves or do not wish to participate.
• Patients who need an interpreter.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• University of East Anglia: collaborator

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Edward St John

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Gedge

CONTACT

02392286000; ian.gedge@porthosp.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: March 7, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)