Condition category
Cancer
Date applied
14/09/2017
Date assigned
12/12/2017
Last edited
07/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many people recovering from bowel cancer require surgery. If a section of the bowel is removed, the surgeon may temporarily divert the faeces by bringing a loop of bowel out through the abdominal wall and attaching it to the skin – this is called a stoma. A bag is worn over the stoma to collect the faeces. The formation of a stoma has many repercussions for the patient including low energy, tiredness, poor body image, fears of leakage, and fears of a hernia. These problems affect patient quality of life, and can be a barrier to being physically active. Activity levels might be improved in this patient group by addressing the concerns they have about their stoma, and by offering them input from a physical activity specialist. The aim of this study is to look at whether bowel cancer patients with a stoma enjoy a physical activity programme, and if it is beneficial.

Who can participate?
Patients with bowel cancer undergoing surgery with the formation of a temporary or permanent stoma

What does the study involve?
About 6 weeks after their surgery, the participants are offered a 12-week programme of physical activity intervention from exercise specialists. They record their activities in a diary, and are also given a device to measure their daily step counts. This study assesses how many patients participate, what activities they do each week; patients, clinicians and physical activity specialists’ opinions on the intervention; and if there are improvements in quality of life, function and fatigue.

What are the possible benefits and risks of participating?
This is the first study to find out whether bowel cancer patients with a stoma enjoy a physical activity programme, and if it beneficial to them. There is great potential to improve quality of life by addressing the stoma-related barriers to being physically active. Participants may expect to see improvements in their day to day activity by doing more steps each day. Previous studies of a similar nature have also seen improvements in quality of life and in confidence to be more active. The main risk of taking part is the risk of hernia formation at the site of the stoma, but this can be avoided by not putting undue pressure on the abdomen. Recent guidelines suggest that some exercises, and being active, can reduce the risk of a hernia forming.

Where is the study run from?
1. NHS Highland (UK)
2. University College London Hospitals NHS Foundation Trust (UK)
3. London North West Healthcare NHS Trust (UK)

When is the study starting and how long is it expected to run for?
September 2017 to August 2018

Who is funding the study?
Bowel and Cancer Research (UK)

Who is the main contact?
Mrs Julie Munro

Trial website

Contact information

Type

Public

Primary contact

Mrs Julie Munro

ORCID ID

Contact details

School of Health
Social Care and Life Sciences
University of the Highlands and Islands (UHI)
Centre for Health Sciences
Old Perth Road
Inverness
IV2 3JH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1109JH_UHI_ALL

Study information

Scientific title

A physical activity intervention to improve the quality of life of bowel cancer patients with a stoma: a feasibility study

Acronym

Study hypothesis

This is the first study to look at whether bowel cancer patients with a stoma enjoy a physical activity programme, and if it is beneficial. This is a feasibility trial, so there is no hypothesis.

Ethics approval

North of Scotland Research Ethics Committee, 11/07/2017, ref: 17/NS/0065, IRAS ID: 219548

Study design

Multi-centre feasibility study

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 to request a patient information sheet

Condition

Bowel cancer patients with a stoma

Intervention

This study is testing the feasibility of a physical activity intervention. This will be offered to patients following their surgery for bowel cancer, where a stoma has been created. Patient will be offered to take part in a 12 week programme of physical activity intervention from exercise specialists. Participants will undergo initial assessment, and will be given an exercise prescription once a week for 12 weeks. They will record their activities in a diary, and will also be given a device to measure their daily step counts. Physical activity prescription will either be given face-to-face or via video conference.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The feasibility and potential benefit of a physical activity intervention for bowel cancer patients with a stoma:
1. How many patients participate, and what and how much physical activity they do each week. They will record their activities in a diary, and will also be given a device to measure their daily step counts
2. Opinions of all those involved in the trial, namely patients, stoma nurses, and exercise specialists about the intervention, collected by semi-structured interviews at the end of the 12 week intervention. All semi-structured interviews will be audio recorded (as included in patient consent form), and transcribed. Transcriptions will be examined by 2 members of the research team for thematic analysis
3. Any improvements made in quality of life, physical function, and fatigue (see below)

Measured at baseline and at 12 weeks:
1. Quality of life, assessed using the Stoma Quality of Life scale
2. Fatigue, assessed using FACIT fatigue
3. Body image, assessed using FACT-C
4. Physical activity levels, measured by accelerometry for 7 consecutive days through waking hours
5. Physical function, measured using the following:
5.1. 6-minute walk test
5.2. Sit to stand test
5.3. Arm curl
5.4. Sit and reach test

Secondary outcome measures

1. Screening, eligibility, consent and intervention completion rates:
1.1. Screening and eligibility will be collected throughout the 6-month recruitment period by clinical nurse specialists. Patient screening forms have been provided for this purpose
1.2. Verbal consent for contact will be obtained by a member of the direct healthcare team. A verbal consent form will be passed on to one of two researchers for initial contact. Initial contact will be no sooner than 6 weeks post-surgery. Informed consent will be obtained by one of two trial researchers. This involves a fully informed consent and after a period of discussion around what is involved for the participant. A patient information sheet is given in advance to ensure the participant has all the information required, and can make an informed decision about their potential involvement
1.3. Intervention completion will be recorded by the trial exercise specialists who will be providing the intervention. This will be recorded through attendance records throughout the 12-week intervention (this includes recording completed teleconference calls, which are considered as an ‘attended’ session). Data completion will consist of baseline measures (taken at baseline), and completion measures (taken after the 12-week intervention). Data collection involves accelerometer data (device worn for 7 days, pre- and post-intervention); questionnaire completion (pre-and post-intervention)
2. The number of consultations taking place between patients and exercise specialists. The trial intervention is 12 weeks long, and consultations are weekly. These may be face to face, or via video call, or a combination of both. Number of consultations will be recorded for each participant, along with length of time of each consultation
3. The acceptability of this intervention for this patient population, recorded through semi-structured interview at the end of the intervention, along with consent rates and intervention completion rates to indicate the acceptability of the intervention with this patient population

Overall trial start date

01/09/2017

Overall trial end date

31/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients diagnosed with bowel cancer
2. Undergoing elective colorectal resections including open and laparoscopic procedures
3. The formation of a temporary or permanent stoma
4. Patients undergoing pre and post radiotherapy, and chemotherapy
5. WIth and without parastomal hernia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Patients who have undergone emergency surgery for bowel cancer
2. The patient's clinician deems the patient unsuitable for engaging in any sort of physical activity. Clinician may be surgeon, consultant gastroenterologist, oncologist, or nurse specialist

Recruitment start date

01/11/2017

Recruitment end date

30/11/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Highland
IV2 3JH
United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
NW1 2PG
United Kingdom

Trial participating centre

London North West Healthcare NHS Trust
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Bowel and Cancer Research

Sponsor details

National Bowel Research Centre
1st Floor
Abernethy Building
2 Newark Street
London
E1 2AT
United Kingdom

Sponsor type

Charity

Website

http://www.bowelcancerresearch.org/

Organisation

NHS Highland

Sponsor details

CfHS
Old Perth Road
Inverness
IV2 3JH
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Charity

Funder name

Bowel and Cancer Research

Alternative name(s)

Bowel & Cancer Research

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Study protocol is available on request. High impact peer reviewed journals will be targeted. Following completion of the trial, the intention is to share and disseminate the findings in a range of clinical conferences and networks (e.g. health and physical activity; stoma care; bowel cancer).

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Gill Hubbard (gill.hubbard@uhi.ac.uk).
Data: quantitative – questionnaires (raw data can be provided), Actigraph physical activity data (raw format). Qualitative data will not be available
Any data provided through data sharing will be fully anonymised. Participants will be led through fully informed consent stating that anonymised data may be shared outwith the organisation following their completion of the trial. Qualitative data will not be available for sharing on the premise that it may lead to identification of a participant, trial site, or health professional involved. Data will be shared at the discretion of the principal investigator, who will comply fully with the ethical obligations for data protection as set out during trial IRAS registration.

Intention to publish date

31/01/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 30/04/2018 to 30/11/2018. 2. The overall trial end date was changed from 31/08/2018 to 31/01/2019. 3. The intention to publish date was changed from 31/12/2018 to 31/01/2020.