A bowel management intervention for individuals following rectal cancer treatment: assessing feasibility, acceptability and potential effectiveness

ISRCTN	ISRCTN27625148
DOI	https://doi.org/10.1186/ISRCTN27625148
Secondary identifying numbers	9931

Submission date: 24/05/2011
Registration date: 24/05/2011
Last edited: 29/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-way-of-helping-people-cope-with-bowel-problems-after-treatment-for-rectal-cancer

Contact information

Dr Claire Taylor
Scientific

Florence Nightingale School of Nursing and Midwifery
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom

Email	gillian.taylor@kcl.ac.uk

Study information

Study design	Non-randomised, interventional
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A bowel management intervention for individuals following rectal cancer treatment: assessing feasibility, acceptability and potential effectiveness
Study objectives	A bowel management intervention will be tested upon a cohort of up to 40 patients who have been diagnosed with curative rectal cancer and will be treated by sphincter-saving surgery +/- other cancer treatments. The intervention will have two parts: the first is the delivery of written information and appropriate contact numbers/web-sites and the second is a specific bowel intervention for those with change in bowel habit which consists of one face-to-face appointment and two telephone follow-up calls. Bowel function and quality of life measures will be administered to the sample pre and post these interventions which are orientated to their treatment schedule: pre-treatment, 6 weeks, five months and ten months post-treatment. Evaluation will be through use of both quantitative and qualitative outcomes including the ICIQ-B Bowel Assessment Instrument (Cotterill et al, 2008), Quality of Life Short Form SF36 and the My Caw tool. There will also be qualitative interviews with members of the cohort who are willing to participate in this additional evaluative feature of the study and a survey of healthcare professionals involved in the follow up care of rectal cancer patients. Assessment of process and other study effects will also be made.
Ethics approval(s)	First Medical Ethics Research Committee Ref: 10/H0709/65; approval date 02/11/2010
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	1. Bowel management - the planned intervention is based on the current method of Biofeedback therapy offered at St Mark's for patients referred with bowel symptoms of urgency and incontinence 2. It will be given by the researcher with support from the Biofeedback team 3. To ensure all patients receive consistent pre-operative care, they will all be offered relevant written information about their treatments prior to treatment 4. This information provides necessary preparation for what to expect following treatment 5. Follow Up Length: 10 months 6. Study Entry: Registration only
Intervention type	Other
Primary outcome measure	ICIQ-B; Timepoint(s): pre treatment, 6 weeks post treatment, 5 months, 10 months
Secondary outcome measures	1. Bowel assessment and QOL 2. Timepoint(s): 1) the ICIQ-B Bowel Assessment Instrument (Cotterill et al, 2008) 3. Quality of Life Short Form (SF)
Overall study start date	02/03/2011
Completion date	30/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 40
Total final enrolment	28
Key inclusion criteria	1. Diagnosis of curative rectal cancer 2. Consents to sphincter saving surgery 3. Over 18 4. Able to speak and read English 5. Patients having pre-op radiotherapy (RT) will be included which may be a short or long course of treatment. Occasionally the RT will be so effective that surgery will not be required can still be included. 6. Patients may also have post-operative radiotherapy and chemotherapy treatments 7. Male & Female 8. Lower Age Limit 18 years
Key exclusion criteria	1. Unable to articulate their diagnosis of cancer due to denial, confusion, learning disability 2. Local excision surgery 3. Surgery involving formation of permanent stoma 4. Under 18 5. Unable to read study measures and/or has a level of spoken English which requires a translator. 6. Patients who do not want to participate in the intervention
Date of first enrolment	02/03/2011
Date of final enrolment	30/03/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Florence Nightingale School of Nursing and Midwifery

London
SE1 8WA
United Kingdom

Sponsor information

North London Cancer Research Network (UK)
Research organisation

Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom

Website	http://www.nlcn.nhs.uk/

Funders

Funder type

Research organisation

National Cancer Survivorship Initiative (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results		20/05/2016	29/03/2022	No	Yes

Editorial Notes

29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
07/07/2017: No publications found in PubMed, verifying study status with principal investigator.