Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Mrs Helen Ludlow
ORCID ID
Contact details
Department of Gastroenterology
University Hospital Llandough
Penarth
CF64 2XX
United Kingdom
029 20716403
helens@cardiff.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRAS 201783
Study information
Scientific title
Improving awareness among health care professionals of what people experience when they have bowel problems after pelvic radiotherapy via narrative analysis
Acronym
Study hypothesis
The number of people surviving a cancer diagnosis is growing and yet so are the unintended consequences of the cancer treatment. When radiotherapy is given to treat pelvic cancers up to 90 % of patients may have late GI symptoms, now known as Pelvic Radiation Disease (PRD). Whereas there are quantitative studies measuring quality of life in this group of people there is very little qualitative data regarding lived experience- what is it like to have life-changing bowel problems after completing the cancer treatment. It is hoped that this study will raise awareness amongst health care professionals about PRD and improve the current availability of specialist gastroenterology treatment.
Ethics approval
The Ethics Board is Health Care Research Wales, 09/06/2016, ref: 16/WA/0126
Study design
Single site observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format. Please use contact details to request a participant information sheet
Condition
Pelvic Radiation Disease
Intervention
A narrative analysis will be used to analyse the qualitative interviews to gain an understanding of the experience of living with PRD. Each participant will have an interview lasting approximately 1 hour. This will be face-to face, either in the participant’s home or the Out-Patient Department. The narrative analyses will depend on the patients response to the interview.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Life stories in narrative form, created by collecting peoples experiences of living with PRD (via face-to-face interviews) and developing a narrative to improve health care professionals understanding
Secondary outcome measures
N/A
Overall trial start date
01/10/2015
Overall trial end date
01/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged >18 years
2. Been referred to the PRD clinic in the trial site hospitalwith bowel problems at least 6 months post-completion of pelvic radiotherapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 10 participants
Participant exclusion criteria
Unable to participant in an interview
Recruitment start date
01/08/2016
Recruitment end date
01/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Llandough
Penlan Road
Llandough
Penarth
The Vale of Glamorgan
CF64 2XX
United Kingdom
Sponsor information
Organisation
Cardiff University
Sponsor details
School of Healthcare Sciences
Eastgate House
Newport Road
Cardiff
CF24 0AB
United Kingdom
029 20687555
gamblingts@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publish in a high impact peer reviewed journal.
Intention to publish date
01/10/2019
Participant level data
Available on request
Basic results (scientific)
See additional file (ISRCTN12279556_BasicResults_3Sep18)
Publication list
Publication citations
Additional files
- ISRCTN12279556_BasicResults_3Sep18.pdf Uploaded 03/09/2018