Condition category
Cancer
Date applied
16/05/2016
Date assigned
18/05/2016
Last edited
05/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Not provided at time of registration

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 measures

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

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

To be confirmed at a later date

Intention to publish date

01/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/12/2016: Cancer Help UK lay summary link added to plain English summary field.