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

NCT04024189 | Completed DMC

• 1 other identifier: 18/2117
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  6 weeks

• Patients views and feelings regarding their experiences in relation to support from healthcare professionals was assessed using a study specific patient questionnaire.

  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.

  6 week

Interventions

Survey OTHER

Patients were given a questionnaire/survey to complete in respect of their satisfaction of the consent process for their surgical procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing surgery during a 6 week period at The Christie NHS Foundation Trust

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Omer Aziz

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: July 18, 2019
• Study Start: April 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: August 10, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)