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Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet (BOUNCED)

Primary Purpose

Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
Royal Surrey County Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring diet, dietary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years of age
  • Able to tolerate oral diet
  • Confirmed diagnosis of SBO due to underlying malignancy to include:

    1. Patients with colorectal or gynaecological cancers with primary or secondary tumour in situ, undergoing cancer treatment or supportive care.
    2. Patients diagnosed with advanced inoperable cancers of colorectal or gynaecological origin
  • Presenting in outpatient clinics or admitted from A&E with a minimum of 2 symptoms of SBO including: abdominal pain, bloating after eating, early satiety, nausea, vomiting
  • Capacity to give informed consent

Exclusion Criteria:

  • Patients under 18 years of age
  • No symptoms of bowel obstruction
  • Have not already been given advice to follow the 4 stage bowel obstruction diet
  • Unable to tolerate oral diet i.e. enterally or parenterally fed
  • Unable to provide capacity to give informed consent
  • Unable to read and communicate in the English language

Sites / Locations

  • Royal Surrey NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4 stage bowel obstruction diet

Arm Description

All eligible participants will be assessed by a specialist dietitian and a diet history and symptoms will be recorded. Depending on the degree of sub-acute bowel obstruction, symptoms and type of diet being followed, patients will be given detailed instructions on which stage of the 4 stage diet to use. They will be followed up by telephone or face to face weekly for a 4 week period and shown how to alter their diet by moving up and down the stage of the diet if symptoms resolve or worsen. This is current standard of care. Additional assessments will be carried out at the start and end of the study when participants will complete the Memorial Symptom Assessment Scale (MSAS) and EORTC QLQ-30 quality of life questionnaire. They will be asked to complete a daily diet diary, and an 'ease of use' questionnaire at the end of the 4 week period.

Outcomes

Primary Outcome Measures

Symptoms of sub-acute bowel obstruction: abdominal pain, feeling bloated, feeling full-up quickly, nausea and / or vomiting
Measured by completion of the Memorial Symptom Assessment Scale questionnaire (MSAS): a well-validated questionnaire, which asks about the frequency, severity and psychological effect of 32 symptoms. For the purpose of this study, the MSAS has been adapted to include the key additional symptom of early satiety (feeling full up quickly) that can be experienced by patients with sub-acute bowel obstruction. It is graded on a scale of 0 (not at all) - 4 (very much).

Secondary Outcome Measures

A&E attendances or hospital admissions after starting to use the 4 stage diet
No of hospital admissions and A&E attendances due to bowel obstruction in the 3 months prior to consent will be recorded. This will be compared with the number of admissions during the 4 weeks patients are on the trial.
Health related Quality of Life
Measured by using the EORTC Quality of Life QLQ-C30 questionnaire will be collected at baseline on entry to the study and after 4 weeks on completion of the study. QLQ-C30 developed by EORTC is designed to measure cancer patients' physical, psychological and social functions. It is scored on a scale from 0 (not at all) - 4 (very much).
Weight
Measured in kilograms and as a percentage indicating percentage weight change from start to end of the trial. Participants will be weighed on consent and after 4 weeks.

Full Information

First Posted
October 6, 2020
Last Updated
May 18, 2021
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04898842
Brief Title
Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet
Acronym
BOUNCED
Official Title
BOUNCED: 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Surrey County Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. Patients at risk of bowel obstruction from colorectal or ovarian cancer are eligible to participate. They will remain in the study for a period of 4 weeks, during which time they will be asked to complete a diet diary and 3 questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Adenocarcinoma, Colorectal Cancer Metastatic, Ovarian Cancer, Ovarian Neoplasm, Metastatic Colorectal Cancer, Metastatic Ovary Cancer, Peritoneal Carcinomatosis, Bowel Obstruction
Keywords
diet, dietary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 stage bowel obstruction diet
Arm Type
Experimental
Arm Description
All eligible participants will be assessed by a specialist dietitian and a diet history and symptoms will be recorded. Depending on the degree of sub-acute bowel obstruction, symptoms and type of diet being followed, patients will be given detailed instructions on which stage of the 4 stage diet to use. They will be followed up by telephone or face to face weekly for a 4 week period and shown how to alter their diet by moving up and down the stage of the diet if symptoms resolve or worsen. This is current standard of care. Additional assessments will be carried out at the start and end of the study when participants will complete the Memorial Symptom Assessment Scale (MSAS) and EORTC QLQ-30 quality of life questionnaire. They will be asked to complete a daily diet diary, and an 'ease of use' questionnaire at the end of the 4 week period.
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptoms of sub-acute bowel obstruction: abdominal pain, feeling bloated, feeling full-up quickly, nausea and / or vomiting
Description
Measured by completion of the Memorial Symptom Assessment Scale questionnaire (MSAS): a well-validated questionnaire, which asks about the frequency, severity and psychological effect of 32 symptoms. For the purpose of this study, the MSAS has been adapted to include the key additional symptom of early satiety (feeling full up quickly) that can be experienced by patients with sub-acute bowel obstruction. It is graded on a scale of 0 (not at all) - 4 (very much).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
A&E attendances or hospital admissions after starting to use the 4 stage diet
Description
No of hospital admissions and A&E attendances due to bowel obstruction in the 3 months prior to consent will be recorded. This will be compared with the number of admissions during the 4 weeks patients are on the trial.
Time Frame
4 weeks
Title
Health related Quality of Life
Description
Measured by using the EORTC Quality of Life QLQ-C30 questionnaire will be collected at baseline on entry to the study and after 4 weeks on completion of the study. QLQ-C30 developed by EORTC is designed to measure cancer patients' physical, psychological and social functions. It is scored on a scale from 0 (not at all) - 4 (very much).
Time Frame
4 weeks
Title
Weight
Description
Measured in kilograms and as a percentage indicating percentage weight change from start to end of the trial. Participants will be weighed on consent and after 4 weeks.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age Able to tolerate oral diet Confirmed diagnosis of SBO due to underlying malignancy to include: Patients with colorectal or gynaecological cancers with primary or secondary tumour in situ, undergoing cancer treatment or supportive care. Patients diagnosed with advanced inoperable cancers of colorectal or gynaecological origin Presenting in outpatient clinics or admitted from A&E with a minimum of 2 symptoms of SBO including: abdominal pain, bloating after eating, early satiety, nausea, vomiting Capacity to give informed consent Exclusion Criteria: Patients under 18 years of age No symptoms of bowel obstruction Have not already been given advice to follow the 4 stage bowel obstruction diet Unable to tolerate oral diet i.e. enterally or parenterally fed Unable to provide capacity to give informed consent Unable to read and communicate in the English language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Allan
Phone
01483 464119
Email
lindseyallan@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Penhaligon
Phone
01483 688539
Email
k.penhaligon@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Allan
Organizational Affiliation
Royal Surrey NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agnieszka Michael
Organizational Affiliation
Royal Surrey NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Surrey NHS Foundation Trust
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet

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