BOUNCED: are cancer patients diagnosed with partial bowel obstruction able to follow a 4 stage diet and does it reduce symptoms and improve quality of life?
| ISRCTN | ISRCTN10518796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10518796 |
| IRAS number | 272626 |
| Secondary identifying numbers | CPMS 48020, IRAS 272626 |
- Submission date
- 25/01/2021
- Registration date
- 15/02/2021
- Last edited
- 15/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Bowel obstruction is a common complication in patients with ovarian, peritoneal and bowel cancer due to a mass or spread of disease, causing narrowing to the gut, as these cancers can grow on the bowel surface. Certain foods may lead to symptoms such as pain, bloating, feeling full, feeling sick, vomiting and difficulty passing a bowel motion. There is limited evidence to establish the best diet to follow when someone is diagnosed with the risk of bowel obstruction and is experiencing symptoms after eating and drinking.
The Dietitians at the Royal Surrey have developed a 4 stage bowel obstruction diet which they have been using with patients for 3 years. The 4 stages are clear fluids, all thin liquids, low fibre soft smooth diet, low fibre soft sloppy diet. Depending on the severity of symptoms and the risk of a blockage, patients are asked to follow a certain stage of the diet. They are advised to move up and down the stages as symptoms improve or get worse.
This feasibility study aims to investigate if the diet can be used and is effective in clinical practice. The objectives are to see if this diet is easy to follow, can reduce symptoms of bowel obstruction, can improve quality of life, and reduce admissions to hospital because of bowel blockages.
Who can participate?
Patients who have had a CT scan and have been shown to be at risk of bowel obstruction with a partial blockage due to colorectal, ovarian, or peritoneal cancer, and are experiencing symptoms as a result.
What does the study involve?
After signing a consent form the dietitian will explain how the 4 stage diet works and which stage of the diet each participant starts from. They will also explain what to do if symptoms get worse or better and how to move to a different stage of the diet.
During the study, participants will be asked to complete a simple diet diary every day, as well as 3 other questionnaires. These will ask about symptoms and aspects that may affect their quality of life and will need to be completed at the start and the end of the trial. On the last day of the trial, they will also be asked to answer 4 questions about how easy or difficult they found the diet to follow.
Involvement in the study will last for 4 weeks (28 days). The dietitian will review participants weekly during the study. This will either be in person at the cancer centre or at home by telephone or video call.
What are the possible benefits and risks of participating?
The benefits of taking part in the study are not yet known, but it is hoped that the results will help patients in the future. The 4 stage bowel obstruction diet has not been shown to cause harm and is a safe form of nutrition. Participants may develop symptoms from their cancer that are not necessarily related to the diet and will receive help with these. It is not anticipated that following the 4 stage diet will prevent routine cancer care from going ahead.
Where is the study run from?
St Luke’s Cancer Centre in Guildford (UK) and the Royal Surrey Hospital in Guildford, Surrey (UK)
When is the study starting and how long is it expected to run for?
From February 2019 to November 2022
Who is funding the study?
GUTS Fighting Bowel Cancer (UK)
Who is the main contact?
Lindsey Allan, lindseyallan@nhs.net
Contact information
Scientific
Macmillan Oncology Dietitian
Department of Nutrition and Dietetics
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
| Phone | +44 (0)1483 464119 |
|---|---|
| lindseyallan@nhs.net |
Study information
| Study design | Mixed methods single-arm non-randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Managing oral diet following a diagnosis of sub-acute bowel obstruction: a feasibility study exploring the efficacy of a 4 stage Bowel ObstrUctioN CancEr Diet and quality of life in cancer patients (BOUNCED) |
| Study acronym | BOUNCED |
| Study hypothesis | To determine whether a 4 stage bowel obstruction diet as a means of managing oral intake in patients symptomatic with malignant sub-acute bowel obstruction (SBO) is deliverable and effective in clinical practice. |
| Ethics approval(s) | Approved 05/02/2021, West Midlands - Solihull Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham NG1 6FS; +44 (0)207 1048310; solihull.rec@hra.nhs.uk), REC ref: 21/WM/0006 |
| Condition | Bowel obstruction as a result of colorectal or ovarian cancer |
| Intervention | At baseline, participants will be provided with a participant information sheet and assessed for eligibility. After signing a consent form the participants will also be weighed and asked about personal details, medical history, cancer history, and any concomitant medications or treatment being used. The dietitian will explain to participants how the 4 stage diet works and which stage of the diet each participant starts from. They will also explain what to do if symptoms get worse or better and how to move to a different stage of the diet. Participants will be asked to follow the 4 stage diet for 4 weeks (28 days). During the study, participants will be asked to complete a simple diet diary every day. Participants will also be asked to complete 2 questionnaires both at the start and end of the study. These will ask about symptoms and aspects that may affect quality of life. On the last day of the trial, participants will also be weighed and asked to answer a 4 stage ease of use questionnaire about how easy or difficult they found the diet to follow. The dietitian will review participants weekly during the study either in person at the cancer center or at home by telephone or video call. This review will include a review of any adverse events, concomitant medications or treatment, diet diary, stages of the diet participants have followed during the preceding 7 days since their last review, and details of any oral nutritional supplements used (to include the name and how many taken each day). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Acceptability of a 4 stage diet to patients measured using the ease of use questionnaire at 4 weeks 2. Symptoms of sub-acute bowel obstruction (abdominal pain, feeling bloated, feeling full-up quickly, nausea, or vomiting) measured using the Memorial Symptom Assessment Scale questionnaire (MSAS) at baseline and 4 weeks. The MSAS has been adapted to include the key additional symptom of early satiety that can be experienced by patients with sub-acute bowel obstruction and will be graded on a scale of 0 (not at all) to 4 (very much). |
| Secondary outcome measures | 1. A&E attendances or hospital admissions due to bowel obstruction will be measured from hospital records between 3 months prior to the study and baseline, and between baseline and 4 weeks 2. Health-related Quality of Life measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (QLQ-C30) at baseline and 4 weeks 3. Weight measured in kilograms and as a percentage indicating percentage weight change from start to end of the trial at baseline and 4 weeks |
| Overall study start date | 01/02/2019 |
| Overall study end date | 02/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 30 |
| Total final enrolment | 30 |
| Participant inclusion criteria | Current inclusion criteria as of 14/12/2022: 1. Aged ≥18 years 2. Able to tolerate the oral diet 3. Diagnosis of colorectal cancer with a primary tumour in situ, locally advanced disease or peritoneal spread causing clinical symptoms of bowel obstruction OR diagnosis of gynaecological cancer with spread to the peritoneum causing clinical symptoms of bowel obstruction 4. Bowel obstruction considered inoperable at the time of consent 5. Presenting with any of the following clinical symptoms of sub-acute bowel obstruction: 5.1. Abdominal pain 5.2. Bloating after eating 5.3. Early satiety 5.4. Nausea 5.5. Vomiting 6. Capacity to give informed consent Previous inclusion criteria: 1. Aged ≥18 years 2. Able to tolerate the oral diet 3. Confirmed diagnosis of sub-acute bowel obstruction due to underlying malignancy including those with colorectal or gynaecological cancers with a primary or secondary tumour in situ and those undergoing cancer treatment or supportive care 4. Patients diagnosed with advanced inoperable cancers of colorectal or gynaecological origin 5. Presenting in outpatient clinics or admitted from A&E with a minimum of 2 symptoms of the following subacute bowel obstruction: 5.1. Abdominal pain 5.2. Bloating after eating 5.3. Early satiety 5.4. Nausea 5.5. Vomiting 6. Capacity to give informed consent |
| Participant exclusion criteria | 1. No symptoms of bowel obstruction 2. Have not already been given the advice to follow the 4 stage bowel obstruction diet 3. Unable to read and communicate in the English language |
| Recruitment start date | 02/03/2021 |
| Recruitment end date | 05/10/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Guildford
GU2 7XX
United Kingdom
Sponsor information
Hospital/treatment centre
Department of Research, Development and Innovations
Leggett Building
Daphne Jackson Road
Guildford
GU2 7WG
England
United Kingdom
| Phone | +44 (0)1483686539 |
|---|---|
| k.penhaligon@nhs.net | |
| Website | http://www.royalsurrey.nhs.uk/ |
"ROR" |
https://ror.org/050bd8661 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Guts UK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Lindsey Allan, lindseyallan@nhs.net |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 14/11/2024 | 15/11/2024 | No | No | |
| Results article | 05/11/2024 | 15/11/2024 | Yes | No |
Additional files
Editorial Notes
15/11/2024: The following changes were made to the trial record:
1. The study participating centre Frimley Health NHS Foundation Trust was removed.
2. The participant level data sharing statement was added.
3. The basic results have been uploaded as an additional file.
4. Publication reference added.
18/12/2023: The intention to publish date was changed from 31/03/2023 to 31/01/2024.
14/12/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2022 to 02/11/2022 and the plain English summary was updated accordingly.
2. The inclusion criteria were changed.
3. Total final enrolment was added.
4. The recruitment end date was changed from 30/11/2022 to 05/10/2022.
5. The intention to publish date was changed from 31/12/2023 to 31/03/2023.
24/03/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2021 to 02/03/2021.
2. Ethics approval details added.
25/01/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).
