Current public title as of 28/02/2019: Physical activity for people recovering from bowel cancer, or with inflammatory bowel disease who have a stoma Previous public title: Physical activity for people recovering from bowel cancer who have a stoma

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN58613962

Enrollment

Registered

2017-12-12

Start date

2017-11-01

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel cancer patients with a stoma Cancer

Interventions

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 of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 28/02/2019: 1. Patients diagnosed with bowel cancer or inflammatory bowel disease. 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 Previous 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Contacts

Public ContactJulie Munro

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026