Breast CancerPRCNCT06351865
Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
An observational study of Breast Cancer and Complication of Surgical Procedure, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Complication of Surgical Procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Mar 2024to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over 18yrs old with early invasive breast cancer who are undergoing "wide local excision and sentinel lymph node biopsy" operation.
Who may be able to join
- 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.
Who cannot join
- Unable to consent for themselves or do not wish to participate.
- Patients who need an interpreter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Edward St John, 02392286000, edward.stjohn@porthosp.nhs.uk
About this study
Official title: A Feasibility Study to Evaluate if Breast Cancer Patients, Consented Using Digital Consent, Reliably Provide Accurate Patient Reported Complication (PRC) Data Using Feedback Questionnaires
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.
Read the 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
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who respond to the feedback questionnaire
Calculate the proportion of patients who respond to the feedback questionnaire
Measured: 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.
Measured: 6 months
Secondary outcomes (6)
Quoted risks in the consent to the incidence of complications
Compare the quoted risks in the consent to the incidence of complications reported by the patients.
Measured: 6 months
Frequency of PRC and CRCs (Consent Form Reported Complications)
Review the monthly department CGM (Clinical Governance Meeting) data for the study period and correlate the frequency of PRC and CRCs.
Measured: 6 months
Understanding of consent
Calculate the proportion of patients that feedback that they have understood the consent form.
Measured: 6 months
Language used in patient reported complications
Examine the language used by patients in the free-text box for reporting complications and whether this matches to that use in their consent form.
Measured: 6 months
Accuracy of potential complications
To examine the feedback from the patient questionnaire which asks, if they experienced a complication, was it mentioned as a possibility in their consent form.
Measured: 6 months
Participant preparation for surgery
From the feedback from the patient questionnaire, do patients feel fully informed about the procedure they are undertaking and feel well prepared
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start7 Mar 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Edward St John, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351865
- Sponsor's protocol ID
- PHU/2023/21
- Acronym
- PRC
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate if Breast Cancer Patients, Consented Using Digital Consent, Reliably Provide Accurate Patient Reported Complication (PRC) Data Using Feedback Questionnaires
- ClinicalTrials.gov ID
- NCT06351865
- Acronym / sponsor ID
- PRC / PHU/2023/21
- Conditions
- Breast Cancer, Complication of Surgical Procedure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of East Anglia
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18yrs old with early invasive breast cancer who are undergoing "wide local excision and sentinel lymph node biopsy" operation.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to consent for themselves or do not wish to participate.
- Patients who need an interpreter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who respond to the feedback questionnaire
Time frame: 6 months
Calculate the proportion of patients who respond to the feedback questionnaire
Final attrition rate
Time frame: 6 months
Calculate the final attrition rate. This is the proportion of patients who fail to respond to the email questionnaire and telephone call.
6 secondary outcomes
Quoted risks in the consent to the incidence of complications
Time frame: 6 months
Frequency of PRC and CRCs (Consent Form Reported Complications)
Time frame: 6 months
Understanding of consent
Time frame: 6 months
Language used in patient reported complications
Time frame: 6 months
Accuracy of potential complications
Time frame: 6 months
Participant preparation for surgery
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward St John principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Complication of Surgical Procedure, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Gedge (02392286000 ext. 5153, ian.gedge@porthosp.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who respond to the feedback questionnaire (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.