Using a narrative analysis, what is the lived experience of people (and their partners where appropriate) who have gastrointestinal symptoms following pelvic radiotherapy for pelvic cancer
| ISRCTN | ISRCTN12279556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12279556 |
| IRAS number | 201783 |
| Secondary identifying numbers | IRAS 201783 |
- Submission date
- 16/05/2016
- Registration date
- 18/05/2016
- Last edited
- 05/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mrs Helen Ludlow
Public
Public
Department of Gastroenterology
University Hospital Llandough
Penarth
CF64 2XX
United Kingdom
| Phone | 029 20716403 |
|---|---|
| helens@cardiff.ac.uk |
Study information
| Study design | Single site observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | Improving awareness among health care professionals of what people experience when they have bowel problems after pelvic radiotherapy via narrative analysis |
| Study objectives | 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(s) | The Ethics Board is Health Care Research Wales, 09/06/2016, ref: 16/WA/0126 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2015 |
| Completion date | 01/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Approximately 10 participants |
| Key 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 |
| Key exclusion criteria | Unable to participant in an interview |
| Date of first enrolment | 01/08/2016 |
| Date of final enrolment | 01/03/2017 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
University Hospital Llandough
Penlan Road
Llandough
Penarth
The Vale of Glamorgan
CF64 2XX
United Kingdom
Llandough
Penarth
The Vale of Glamorgan
CF64 2XX
United Kingdom
Sponsor information
Cardiff University
University/education
University/education
School of Healthcare Sciences
Eastgate House
Newport Road
Cardiff
CF24 0AB
Wales
United Kingdom
| Phone | 029 20687555 |
|---|---|
| gamblingts@cardiff.ac.uk | |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Other
Investigator initiated and funded
No information available
Results and Publications
| Intention to publish date | 01/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publish in a high impact peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 03/09/2018 | 03/09/2018 | No | No | |
| Plain English results | 05/03/2020 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN12279556_BasicResults_3Sep18.pdf
- Uploaded 03/09/2018
Editorial Notes
05/03/2020: CRUK link to results added to results (plain English).
03/09/2018: The following changes have been made to the trial recordd:
1. The basic results of this trial have been uploaded as an additional file.
2. The publication and dissemination plan was updated.
3. The intention to publish date was updated from 01/06/2018 to 01/10/2019.
04/09/2017: Ethics approval information has been added.
05/12/2016: Cancer Help UK lay summary link added to plain English summary field.
