Improving patient information about recovery after bowel surgery

ISRCTN	ISRCTN62430915
DOI	https://doi.org/10.1186/ISRCTN62430915
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	325201
Protocol serial number	CPMS 58103, IRAS 325201
Sponsor	University of Leeds
Funder	National Institute for Health and Care Research

Submission date: 02/10/2023
Registration date: 10/10/2023
Last edited: 10/04/2025

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

Background and study aims
Bowel cancer is the fourth most common cancer in the UK. Many patients with bowel cancer have an operation, followed by several months of recovery. There is guidance about eating and moving around after an operation but most hospitals give patients poor-quality information about their recovery, which is not accessible, engaging, or supportive. If people understand the recovery process and are more actively engaged in their own recovery, they may have a better and faster return to their everyday lives.
Recover Together is an information package (comprising a booklet, video and goal board) to support patients recovering from bowel surgery. The booklet and video give information about preparing for the operation, and recovering in hospital and at home. The goal board sits at the end of the patient’s hospital bed and is used to set daily goals for their inpatient recovery. These were developed by patients, clinicians and information design experts and are based on existing guidelines for recovery after bowel surgery. They are not currently used in the NHS.
This is a small study (called a feasibility study) which aims to find out whether it is worthwhile running a large trial to see how helpful the new Recover Together booklet, video and goal board are.

Who can participate?
Any patient aged 18 years or over who is due to have an operation for bowel cancer

What does the study involve?
Patients will be given the booklet and a link to the video before their operation. They will be asked to complete some questionnaires about their care, and how useful the booklet was. Some patients and staff will also be asked to give feedback in interviews with a researcher, and the researcher will visit hospital wards to see how the goal boards are used. The findings will help improve the Recover Together information, and tell us whether a large trial is worthwhile.

What are the possible benefits and risks of participating?
There are no serious anticipated risks of taking part in the study. Whilst the researchers cannot be certain about the benefit of the information resources right now, this work will may benefit those taking part and in the future.

Where is the study run from?
University of Leeds (UK)

When is the study starting and how long is it expected to run for?
October 2022 to July 2025

Who is funding the study?
National Institute for Health and Care Research (UK)

Who is the main contact?
Dr Steve Chapman, s.chapman@leeds.ac.uk

Contact information

Dr Stephen Chapman
Principal investigator

Clinical Sciences Building
St James’s University Hospital
Leeds
LS9 7TF
United Kingdom

ORCID ID	0000-0003-2413-5690
Email	s.chapman@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional non-randomized study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Improving recovery after bowel cancer surgery: Mixed-method feasibility study of a co-produced information intervention (Recover Together)
Study acronym	Recover Together
Study objectives	Feasibility hypothesis 1: The Recover Together intervention can be feasibly delivered in NHS practice Feasibility hypothesis 2: A definitive study of the Recover Together intervention can be feasibly delivered in the future
Ethics approval(s)	Approved 31/08/2023, West of Scotland Research Ethics Service (Ground Floor Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 3140212; WoSREC3@ggc.scot.nhs.uk), ref: 23/WS/0136
Health condition(s) or problem(s) studied	Colorectal surgery
Intervention	Recover Together intervention comprising of: 1. Recover Together booklet 2. Recover Together video 3. Recover Together goal board The total duration of the intervention is 3 months.
Intervention type	Other
Primary outcome measure(s)	Intervention feasibility measures: 1. Time taken for intervention set up across participating sites measured according to time from HRA approval to first enrolment 2. Compliance with core processes per resource measured according to the proportion of core processes satisfied per resource 3. Compliance with all core processes per participant measured according to the proportion of all core processes satisfied Study method feasibility measures: 1. Return rate per measurement instrument measured according to the rate of return per instrument 2. Return rate of all instruments per participant measured according to the overall rate of return per participant 3. Rate of missing cost/resource utilisation data measured according to the rate of missing data points All of the feasibility endpoints are measured once at the end of the study
Key secondary outcome measure(s)	Clinical instrument measures: 1. Patient satisfaction measured using the Bauer Patient Satisfaction Questionnaire on Day 1 after surgery 2. Patient well-being measured using the Quality of Recover-15 survey at baseline and on Day 3 after surgery 3. Health-related quality of life measured using the EQ-5D-5L at baseline, Day 30, and 6 months after surgery 4. Functional status measured using the WHO Disability Assessment Schedule 2.0 at baseline and 6 months after surgery 5. Resource use using a bespoke resource-use questionnaire measured at baseline and 6 months after surgery
Completion date	31/07/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	105
Key inclusion criteria	To be eligible for the study, patients must satisfy all of the following inclusion criteria: 1. Aged >= 18 years 2. Able to provide written informed consent 3. Planned to undergo elective colorectal surgery (with or without a stoma) 4. Indication for surgery is for suspected or confirmed colorectal cancer For the staff interviews, we will include staff who have experience of introducing the video and booklet in outpatient clinics, and/or delivering the goal board on the ward, as well as staff who have trained other staff in how to deliver the intervention.
Key exclusion criteria	No further exclusion criteria will apply although participants will be required to understand either English or Urdu language. There will be no exclusions based on literacy or disability.
Date of first enrolment	01/11/2023
Date of final enrolment	01/11/2024

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St James University Hospital

Gledow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during the current study will be available upon request and following consideration of a statistical analysis plan. These requests should be sent to the main contact (Dr Steve Chapman; s.chapman@leeds.ac.uk). If approved, data will be provided in anonymised form.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		04/11/2024	06/11/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/04/2025: The overall end date was changed from 01/04/2025 to 31/07/2025.
06/11/2024: Publication reference added.
02/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).