Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Complication of Surgical Procedure. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Proportion of patients who respond to the feedback questionnaire [Time frame: 6 months]
- Final attrition rate [Time frame: 6 months]
Secondary outcome measures (6)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Queen Alexandra Hospital — Portsmouth
Identifiers
NCT: NCT06351865 · PHU/2023/21