Condition category
Cancer
Date applied
24/05/2011
Date assigned
24/05/2011
Last edited
10/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Claire Taylor

ORCID ID

Contact details

Florence Nightingale School of Nursing and Midwifery
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
-
gillian.taylor@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9931

Study information

Scientific title

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

Acronym

Study hypothesis

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

First Medical Ethics Research Committee Ref: 10/H0709/65; approval date 02/11/2010

Study design

Non-randomised, interventional

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

02/03/2011

Overall trial end date

30/03/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 40

Participant 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

Recruitment start date

02/03/2011

Recruitment end date

30/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Florence Nightingale School of Nursing and Midwifery
London
SE1 8WA
United Kingdom

Sponsor information

Organisation

North London Cancer Research Network (UK)

Sponsor details

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

Sponsor type

Research organisation

Website

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

Funders

Funder type

Research organisation

Funder name

National Cancer Survivorship Initiative (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes