Patient Experience of Consent for Cancer Surgery in Light of Recent Changes to UK Law- a Questionnaire Study

Completed

• Conditions: Patient Satisfaction

• Registration Number: NCT04024189
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the treatment being proposed, alternatives to the treatment, and whether reasonable care has been taken to ensure the patient actually knows this. This study aims to determine patients' perspectives of consent for major cancer surgery in light of the Lanarkshire ruling.

Detailed Description

A patient satisfaction survey was administered to patients who had undergone urological, gynaecological, colorectal, and plastic surgical procedures at a specialised cancer centre where changes to consent processes in light of the Lanarkshire ruling had been implemented.

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-08-10
• Study First Submitted: 2019-06-14
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-18
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• All patients who have been admitted and undergone surgery within a 6 week period between April - June 2018.

Exclusion Criteria

• Any patient who could not complete the survey questionnaire i.e. English was not their first language or to unwell to complete.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients understanding of the risks associated with the procedure they will be having and the alternatives available to them was assessed using a study specific questionnaire.	6 weeks	Was the patient made aware by the clinical care team of the risks associated with their procedure and the alternatives available to them. Were they able to make an informed choice. This will be measured using a patient questionnaire
Patients views and feelings regarding their experiences in relation to support from healthcare professionals was assessed using a study specific patient questionnaire.	6 week	Did patients feel that healthcare professionals provided them with sufficient information and support to make an informed decision in respect of their procedure. This will be measured using a questionnaire completed by patients.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom