Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000192684
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
23/02/2023
Date last updated
23/02/2023
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Identification and Multidisciplinary Prehabilitation of at Risk Elderly patients undergoing colorectal cancer therapy (IMPRovE). A feasibility scoping study to implement a prehabilitation programme at Western Health
Scientific title
Identification and Multidisciplinary Prehabilitation of at Risk Elderly patients undergoing colorectal cancer therapy (IMPRovE). A feasibility scoping study to implement a prehabilitation programme at Western Health
Secondary ID [1] 308902 0
Nil Known
Universal Trial Number (UTN)
U1111-1287-9127
Trial acronym
IMPRovE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 328896 0
frailty 328897 0
older age 328898 0
Condition category
Condition code
Cancer 325891 325891 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 325954 325954 0 0
Physiotherapy
Physical Medicine / Rehabilitation 325955 325955 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients equal or over the age of 65 will have a frailty assessment using the G8 scoring system.
Patients who score 14 or below will have a comprehensive geriatric assessment by a geriatrician. A multidisciplinary team (physiotherapy, dietetics) will assess these patients and a prescribed pre habilitation programme will be designed and offered to the patient to complete over a period of 4 weeks. These interventions will be individualised based on clinical assessment. Dietician may prescribe dietary supplementation; physiotherapists may prescribe daily exercise regime and geriatricians may optimise patient drug therapy. However, it will be 1x1 hour consultation per fortnight for 4 weeks as a one on one face to face consultation by both a dietician and physiotherapist. Adherence monitoring will include food diary and exercise diary. Following this programme, patients will then proceed to their planned colorectal cancer surgery. Patients will have a 2 week and 90 day post surgery interview.
Intervention code [1] 325403 0
Treatment: Other
Comparator / control treatment
There is no control. This is a feasibility trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333727 0
Measures of feasibility (composite outcome):-


Evaluation of the acceptability and suitability of the intervention and preliminary evaluation of participant responses to intervention using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and the Feasibility of Intervention Measurement (FIM)
Timepoint [1] 333727 0
At enrolment and week 4 (after enrolment) just prior to surgery
Primary outcome [2] 333911 0
Rate of adherence to the intervention protocol - eg using daily food plan, exercise diary
Timepoint [2] 333911 0
At the time of prehabilitation assessment, review of food plan and exercise diary will be completed
Primary outcome [3] 333912 0
Time to geriatrician and prehabilitation team review by audit of study database
Timepoint [3] 333912 0
At the time of completion of assessments (prehabilitation and geriatrician), review of study database will be performed to gather information on time from recruitment to time to complete assessments
Secondary outcome [1] 418076 0


Surgical complications (Clavien-Dindo classification) from medical records
Timepoint [1] 418076 0
30 day post operation
Secondary outcome [2] 418352 0
post operative mortality from medical records
Timepoint [2] 418352 0
30 day and 90 day post operation
Secondary outcome [3] 418353 0
Geriatric (composite)

Need for sub-acute care, delay to surgery, change to alternative care pathway (i.e.: non-surgical resection), delirium incidence, pressure injury, falls incidence in hospital. From hospital records
Timepoint [3] 418353 0
30 day post surgery
Secondary outcome [4] 418354 0
Patient-Reported Outcome Measures (PROMs), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Colorectal Cancer Module (EORTC QLQ-CR 29) and Quality of Life of Cancer Patients scale (EORTC QLQ-C30).
Timepoint [4] 418354 0
30 and 90 days after surgery. Patient questionnaire
Secondary outcome [5] 418355 0
Nutrition:-

Weight loss (weigh scale), Patient generated subjective global assessment (PGSGA), pre-albumin (blood test), and hand grip strength with a dynamometer. These will be a composite assessment of the patients total nutritional status rather than multiple outcomes.
Timepoint [5] 418355 0
30 days and 90 days post surgery

Eligibility
Key inclusion criteria
• Aged over 65
• Scoring 14 or less on the G8 screening tool for frailty
• Planned curative intent surgery for primary Colorectal cancer at Western Health
• English speaking and literate
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who present as an emergency to Western Health
Patients who have metastatic disease
Patients who lack the capacity to provide informed consent

Study design
Purpose of the study
Prevention
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
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
22/12/2023
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313111 0
Hospital
Name [1] 313111 0
Western Health, Melbourne
Country [1] 313111 0
Australia
Primary sponsor type
Hospital
Name
Western Health, Melbourne
Address
Footscray Hospital, 160 Gordon Street, Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 314810 0
None
Name [1] 314810 0
Address [1] 314810 0
Country [1] 314810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312360 0
Melbourne Health
Ethics committee address [1] 312360 0
Level 2
South West
300 Grattan Street
Parkville Victoria
3050
Ethics committee country [1] 312360 0
Australia
Date submitted for ethics approval [1] 312360 0
Approval date [1] 312360 0
22/11/2022
Ethics approval number [1] 312360 0

Summary
Brief summary
Currently, frailty is rarely identified prior to surgery and patients undergoing colorectal cancer surgery do not have prehabilitation optimization at Western Health (WH). Recent investigations of our WH population have identified poorer functional outcomes and lower quality of life associated with this population which indicated unmet psychosocial and occupational performance needs.

With this study, we plan to introduce a novel approach to tailored treatment in our most at-risk group of patients.

Who is it for?

You may be eligible for this study if you are an adult who has a planned surgery for primary colorectal cancer at Western Health.

Study details

All patients enrolled in this study will undergo a frailty assessment and be prescribed a pre habilitation to be completed over a period of 4 weeks. This prehabilitation program will include nutritional adjustment by a dietician and improvement of exercise function by physiotherapy.

Patient quality of life questionnaires, food diary, nutritional and physical fitness assessment will be carried out by dieticians and physiotherapists.

It is hoped that this study will show that it is feasible for frail and at-risk colorectal cancer patients undergoing surgery to undergo prehabilitation. This aims to improve strength, mobility and flexibility, reduce frailty, and improve post-operational outcomes such as length of stay.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124378 0
Prof Justin Yeung
Address 124378 0
Level 3, Department of Surgery, WCHRE building, Sunshine Hospital, Furlong Road, St Albans VIC 3021
Country 124378 0
Australia
Phone 124378 0
+61 383958116
Fax 124378 0
Email 124378 0
justin.yeung@unimelb.edu.au
Contact person for public queries
Name 124379 0
Prof Justin Yeung
Address 124379 0
Level 3, Department of Surgery, WCHRE building, Sunshine Hospital, Furlong Road, St Albans VIC 3021
Country 124379 0
Australia
Phone 124379 0
+61 383958116
Fax 124379 0
Email 124379 0
justin.yeung@wh.org.au
Contact person for scientific queries
Name 124380 0
Prof Justin Yeung
Address 124380 0
Level 3, Department of Surgery, WCHRE building, Sunshine Hospital, Furlong Road, St Albans VIC 3021
Country 124380 0
Australia
Phone 124380 0
+61 383958116
Fax 124380 0
Email 124380 0
justin.yeung@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.