Clinical trial NCT06351865: Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Complication of Surgical Procedure
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of East Anglia
First posted: 2024-04-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Proportion of patients who respond to the feedback questionnaire
timeFrame: 6 months
measure: Final attrition rate
timeFrame: 6 months
Secondary outcomes:
measure: Quoted risks in the consent to the incidence of complications
timeFrame: 6 months
measure: Frequency of PRC and CRCs (Consent Form Reported Complications)
timeFrame: 6 months
measure: Understanding of consent
timeFrame: 6 months
measure: Language used in patient reported complications
timeFrame: 6 months
measure: Accuracy of potential complications
timeFrame: 6 months
measure: Participant preparation for surgery
timeFrame: 6 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Edward St John
role: PRINCIPAL_INVESTIGATOR
References: