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

Breast Cancer Clinical Trial

— PRC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06351865
• Other study ID #: PHU/2023/21
• Status: Recruiting
• Start date: March 7, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Portsmouth Hospitals NHS Trust
• Contact: Ian Gedge
• Phone: 02392286000
• Email: ian.gedge[@]porthosp.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2024
• Est. primary completion date: September 19, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Complication of Surgical Procedure

Locations

Country	Name	City	State
United Kingdom	Queen Alexandra Hospital	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who respond to the feedback questionnaire	Calculate the proportion of patients who respond to the feedback questionnaire	6 months
Primary	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	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.	6 months
Secondary	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.	6 months
Secondary	Understanding of consent	Calculate the proportion of patients that feedback that they have understood the consent form.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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	6 months