Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001667101
Ethics application status
Approved
Date submitted
19/11/2019
Date registered
28/11/2019
Date last updated
24/03/2021
Date data sharing statement initially provided
28/11/2019
Date results information initially provided
24/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial of inter-disciplinary PREHABilitation after colonoscopy
Scientific title
Pilot trial of an inter-disciplinary prehabilitation programme for adults referred to surgical services after colonoscopy at Auckland District Health Board
Secondary ID [1] 299726 0
PREHAB
Universal Trial Number (UTN)
Trial acronym
PREHAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 315074 0
Bowel cancer 315343 0
Condition category
Condition code
Cancer 313414 313414 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 313643 313643 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 313644 313644 0 0
Physiotherapy
Physical Medicine / Rehabilitation 313645 313645 0 0
Occupational therapy
Public Health 313646 313646 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be enrolled in a flexible inter-disciplinary prehabilitation programme if they are referred to surgical services after colonoscopy. The aim of this programme is to prepare participants physically, mentally, and emotionally for possible bowel surgery. The programme includes physical activity, physiotherapy, occupational therapy, dietetics, and health psychology. Each of these services will be made available to participants by experienced registered clinicians working in an inter-disciplinary team at the Auckland District Health Board (ADHB). Each of these services are described below. The prehabilitation programme coordinator will first meet with each potential participant to discuss the study, obtain their written informed consent, and assess their needs and preferences for the components of the prehabilitation programme. This is expected to take approximately one hour. The coordinator will then refer participants to services as indicated.

Physical activity: Participants will be invited to complete an exercise test with an ADHB clinical exercise physiologist, to evaluate their current level of cardiovascular fitness and prescribe a programme of supervised high-intensity interval training (HIIT). The programme involves exercising on a treadmill or stationery bike, depending on participant preference and clinician judgement. This programme is designed to efficiently increase cardiovascular fitness in 3 sessions per week for up to 4 weeks, while participants await their surgical treatment. HIIT will begin as soon as possible after participants join the prehabilitation programme, and will stop at least 72 hours prior to scheduled surgery. The duration of the programme is therefore flexible, depending on the amount of time available prior to scheduled surgery. If the 4 week programme is completed prior to surgical treatment, participants will be asked to complete a final CPET and may continue with a maintenance programme that involves 3 sessions per week. The level of intensity of physical activity is monitored in each session by continuous monitoring of participants' heart rate by trained clinicians, who supervise every session. The potential risks and benefits of exercise testing and high intensity interval training are clearly described for participants, and they can choose to opt out of this component of the prehabilitation programme while continuing with the rest of the programme. The clinical exercise physiologist responsible for the initial exercise test will evaluate each participant for contraindications to exercise testing and high intensity interval training. Sessions will be scheduled at participants' convenience whenever possible. Both exercise tests will take place at the Greenlane Clinical Centre. Subsequent training sessions will take place at the Greenlane Clinical Centre or community facilities, such as YMCA gyms, depending upon participant preference and clinician availability. Participants who are contraindicated or who choose not to engage with exercise testing and/or high intensity interval training will be offered education and support to engage in daily moderate physical activity (at least 30 minutes of walking per day), with encouragement from a physiotherapist in the form of weekly telephone calls. This moderate intensity, self-directed activity option will be offered by the prehabilitation programme coordinator, provided there are no contraindications detected using the Physical Activity Readiness Questionnaire (PAR-Q). If contraindications are detected with the PAR-Q, participants will be asked to consult their GP regarding their readiness to undertake a moderate intensity exercise programme, and to follow their GP's advice.

Physiotherapy: Participants with limitations in strength and mobility will be referred to ADHB physiotherapy services for treatment. Therapy will be individualised, and designed to improve the strength and condition of each participant using standard physiotherapy techniques. The physiotherapist will also provide education and support for participants who engage in moderate intensity self-directed physical activity, as described above. Physiotherapy sessions will take place in person at Auckland City Hospital, community centres such as the YMCA, or in the participant's home, depending on participant preferences and physiotherapist availability. Therapy sessions are expected to last no more than an hour, and their frequency will be based on the physiotherapist's clinical judgement and patient preferences. Education and support for moderate intensity self-directed physical activity will take place via telephone or Zoom videoconference, depending on participant preference. Note that Zoom is approved for clinical use by the ADHB.

Occupational therapy: Participants experiencing limitations due to fatigue or with equipment needs at home will be referred to ADHB occupational therapy services as indicated. The prehabilitation coordinator will use the Brief Fatigue Inventory to screen for fatigue and will make a referral to occupational therapy if the score is 6 or more in any of the nine assessment domains. Therapy will be individualised and designed to improve fatigue management and maximise independence in the home environment, using standard occupational therapy approaches. One-on-one sessions will take place at Auckland City Hospital or in the participant’s home, and the location and frequency will depend on participant preferences and therapist availability. All participants will also be invited to attend a fatigue management education session as part of their prehabilitation. The purpose of this session is to provide advice and an opportunity to address any queries or concerns that participants may have. It will last for approximately 30 minutes, and will take place either at Greenlane Clinical Centre, or at a local community facility such as the YMCA, as described above.

Dietetics: Participants will be screened for nutrition needs using the Malnutrition Universal Screening Tool (MUST), and referred to an ADHB dietitian as indicated (score of 2 or more). The dietitian will provide individualised advice and support to improve the nutritional status of referred participants, using standard approaches One-on-one sessions will take place at Auckland City Hospital, in the participant’s home, or via Zoom teleconference, and the location and frequency will depend on participant preferences and therapist availability. All participants will also be invited to attend a nutrition education session as part of their pre-habilitation. The purpose of this session is to provide dietary advice for people preparing for bowel surgery, and an opportunity to address any queries or concerns that participants may have. It will last for approximately 30 minutes, and take place either at Greenlane Clinical Centre, or at a local community facility such as the YMCA, as described above.

Health Psychology: Participants will be screened by the prehabilitation coordinator with the Psychology and Wellbeing Screen (National Comprehensive Cancer Network Distress Thermometer) and referred to ADHB health psychology services as indicated (score of 4 or more). The health psychologist will provide individualised advice, counselling and support to assist referred participants, using standard approaches. One-on-one sessions will take place at Auckland City Hospital, in the participant’s home, or via Zoom teleconference, and the location and frequency will depend on participant preferences and therapist availability. All participants will also be invited to attend an education session to provide general psychological advice for people preparing for bowel surgery, and an opportunity to address any queries or concerns that participants may have. It will last for approximately 30 minutes, and take place either at Greenlane Clinical Centre, or at a local community facility such as the YMCA, as described above.

The effect size of HIIT training will be estimated by calculating the percentage change in VO2max in L/min between the initial and final CPET assessments. The effects of prehabilitation will be measured by: length of hospital stay for participants, compared to a similar cohort of ADHB patients; the Surgical Recovery Scale; and the Post-operative Morbidity Survey. Both scales are assessed at 5- and 30-days post-surgery and assess the recovery after surgery and post-operative adverse events respectively.

Feasibility will be evaluated by recording the proportion of potential participants who consent, the proportion of potential participants who engage with each service they are referred to, adherence to physical activity programmes, and the timeliness with which services are delivered relative to referral date. Qualitative feedback will be sought from participants and their families regarding barriers and facilitators to engaging in prehabilitation. This feedback will be sought in semi-structured interviews with the prehabilitation programme coordinator around 1 week after enrolling, on completion of the prehabilitation programme, and around 1 month after surgery.
Intervention code [1] 315991 0
Rehabilitation
Intervention code [2] 316189 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321888 0
The primary outcome is the effect size of high intensity interval training (HIIT), calculated from the percentage change in VO2Max in L/min between the initial and final CPET assessments.
Timepoint [1] 321888 0
Effect size of HIIT training will be calculated between the initial CPET assessment prior to the HIIT training intervention, and the final CPET assessment immediately after the HIIT training intervention and prior to surgery. This change was made before recruitment of the first participant.
Secondary outcome [1] 376599 0
Timeliness of the prehabilitation programme, measured as the number of days between referral to each service and the first completed appointment with each service, using referral and trial data.
Timepoint [1] 376599 0
Timeliness will be measured for each service component of the programme, between date of referral and date of the first completed appointment.
Secondary outcome [2] 376934 0
Adherence to the prehabilitation programme, measured as the percentage of scheduled prehabilitation sessions completed, with attendance recorded by the clinicians involved in each session and aggregated by the prehabilitation programme coordinator.
Timepoint [2] 376934 0
Adherence will be measured between date of enrollment and date of surgery.
Secondary outcome [3] 376935 0
Participant experience will be evaluated with a customised brief survey and semi-structured interview designed for this study and conducted by the prehabilitation coordinator. The purpose is to understand participants' experiences of the prehabilitation programme, any facilitators and barriers that affected their engagement with the programme, and to hear their advice for possible improvements to the programme.
Timepoint [3] 376935 0
Upon enrollment in the programme, at the conclusion of the programme, and around 1 month after surgery.
Secondary outcome [4] 393297 0
Acceptance of interdisciplinary prehabilitation will be evaluated as the numbers of patients referred, screened, and consented for prehabilitation, based on referral data and trial data.
Timepoint [4] 393297 0
Acceptance will be measured between the date of colonoscopy and the date or surgery.
Secondary outcome [5] 393298 0
Length of inpatient hospital stay after surgery. This will be averaged for the sample and compared to a similar cohort of ADHB patients. Length of inpatient stay will be obtained by review of participants' hospital records.
Timepoint [5] 393298 0
Measured by the number of nights spent in hospital following surgery. This will be assessed at time of follow-up assessment by review of participants' hospital records.
Secondary outcome [6] 393299 0
Post-operative recovery will be measured by the Surgical Recovery Scale
Timepoint [6] 393299 0
This will be measured at days 5 and 30 post-surgery.
Secondary outcome [7] 393300 0
Post-operative complications will be measured by the Post-operative Morbidity Survey
Timepoint [7] 393300 0
Measured at day 5 and 30 post-surgery.

Eligibility
Key inclusion criteria
Completed colonoscopy and referred to surgical services.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive or communication impairment precluding informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2020
Actual
13/07/2020
Date of last participant enrolment
Anticipated
30/09/2020
Actual
2/03/2021
Date of last data collection
Anticipated
31/12/2020
Actual
12/03/2021
Sample size
Target
60
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 22013 0
New Zealand
State/province [1] 22013 0

Funding & Sponsors
Funding source category [1] 304199 0
Charities/Societies/Foundations
Name [1] 304199 0
Bowel Cancer Foundation Trust
Country [1] 304199 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
2 Park Rd
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 304433 0
None
Name [1] 304433 0
Address [1] 304433 0
Country [1] 304433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304666 0
Health and Disability Ethics Committee
Ethics committee address [1] 304666 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 304666 0
New Zealand
Date submitted for ethics approval [1] 304666 0
21/11/2019
Approval date [1] 304666 0
16/12/2019
Ethics approval number [1] 304666 0
19/NTB/222

Summary
Brief summary
This study seeks to collect pilot and feasibility data that will inform the design of future trials of prehabilitation for bowel cancer patients at Auckland District Health Board. People who have had a colonoscopy and have been referred to surgical services will be eligible to take part. Those who decide to participate will be interviewed by a prehabilitation programme coordinator to understand their needs and preferences. They will then be referred for exercise testing and training and physiotherapy, occupational therapy, dietary advice, and health psychology, as needed. The exercise sessions are intense but brief, and are supervised by an exercise physiologist. The prehabilitation programme is focused on high intensity interval training with pre- and post-training assessment of cardiorespiratory fitness. Additional measures of post-surgical outcomes and feasibility data will be collected. This information will help to estimate effect size, and allow accurate calculation of sample size for future trials. Participants will also be interviewed to understand their experience of prehabilitation, and identify the barriers and facilitators to them taking part. The new information gained will be shared with participants, families, and the clinical teams, for sense-checking prior to interpretation and reporting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97782 0
Mr Benjamin Scrivener
Address 97782 0
Allied Health
Level 11 Support Building
Auckland City Hospital
2 Park Rd
Grafton 1023
Auckland
Country 97782 0
New Zealand
Phone 97782 0
+6421825460
Fax 97782 0
Email 97782 0
[email protected]
Contact person for public queries
Name 97783 0
Mr Benjamin Scrivener
Address 97783 0
Allied Health
Level 11 Support Building
Auckland City Hospital
2 Park Rd
Grafton 1023
Auckland
Country 97783 0
New Zealand
Phone 97783 0
+6421825460
Fax 97783 0
Email 97783 0
[email protected]
Contact person for scientific queries
Name 97784 0
Mr Benjamin Scrivener
Address 97784 0
Allied Health
Level 11 Support Building
Auckland City Hospital
2 Park Rd
Grafton 1023
Auckland
Country 97784 0
New Zealand
Phone 97784 0
+6421825460
Fax 97784 0
Email 97784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
These data are not suitable as this is not a phased clinical trial.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.