Low Anterior Resection Syndrome Clinical Trial
Official title:
A Qualitative Research Study Using Patient Focus Groups to Translate International Consensus Definition of Low Anterior Resection Syndrome (LARS) Into a Bowel Dysfunction Severity Scoring Tool.
Verified date | July 2022 |
Source | Cardiff and Vale University Health Board |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to develop a new severity scoring tool for Low Anterior Resection Syndrome (LARS) drawing on the international consensus criteria for LARS as well as opinions of patients with lived-experience of LARS.
Status | Completed |
Enrollment | 8 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged 18 years or older - Able and willing to provide informed consent - Undergone an anterior resection for cancer, with current bowel continuity Exclusion Criteria: - Currently undergoing adjuvant therapy - Recurrent or metastatic disease - Unable to participate to complete study procedures (Due to intellectual or cognitive impairment; Due to insufficient English-language skills (oral and written)) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Julie Cornish | Cardiff |
Lead Sponsor | Collaborator |
---|---|
Cardiff and Vale University Health Board | Cambridge University Hospitals NHS Foundation Trust, University of Aarhus, University of Auckland, New Zealand |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of LARS Severity tool | Qualitative research methods will be used develop the new tool. A patient focus group will be conducted to review the draft questionnaire and refine question and response wordings. | 6 months | |
Secondary | Gain patient opinion on new scoring tool name | Focus groups will be asked to rank proposed tool names from 'least favoured' to 'most favoured'. This will be considered along with clinical opinion to derive final tool name. | 6 months | |
Secondary | Commence initial psychometric evaluation of the New LARS score | Participants will be asked to complete the new LARS score tool, along with existing LARS tool to test proposed question set and administration method as well as comparability to existing tool. | 6 months |
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