Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001075279
Ethics application status
Approved
Date submitted
7/06/2018
Date registered
27/06/2018
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results information initially provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A preliminary survey on the baseline characteristics and preferences for a multimodal prehabilitation in patients scheduled for elective colorectal cancer resection
Scientific title
A preliminary survey on the baseline characteristics and preferences for a multimodal prehabilitation in patients scheduled for elective colorectal cancer resection
Secondary ID [1] 295121 0
None
Universal Trial Number (UTN)
U1111-1215-5385
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Complications 308212 0
Colorectal Cancer 308307 0
Condition category
Condition code
Anaesthesiology 307242 307242 0 0
Other anaesthesiology
Cancer 307309 307309 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients scheduled for bowel resection for colorectal cancer will be recruited. They will be asked to complete questionnaires about their health conditions, fitness levels, psychological status,nutritional status and preferences for a proposed prehabilitation programme assisted by the cancer care co-ordinator. This would require approximately an hour of their time.
That would be the end of their participation in the research project. They will not be required to participate in any programme as a part of this project.
Intervention code [1] 301455 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306198 0
To investigate patient preferences for a proposed future prehabilitation program for colorectal cancer patients
Instrument: Semi-strucured interview
Timepoint [1] 306198 0
Time of baseline interview..
Secondary outcome [1] 347818 0
To evaluate baseline nutritional status of these patients
Instrument: nutritional screening tools described by Ferguson M, Capra S, Bauer J and Banks M. Development of a valid and reliable malnutrition screening tool for adult acute hospital patients. Nutrition 15:458-464. 1999
Timepoint [1] 347818 0
Time of baseline visit.
Secondary outcome [2] 348022 0
To evaluate baseline psychological of these patients
Instruments: DAS-21
Timepoint [2] 348022 0
Time of baseline interview
Secondary outcome [3] 348023 0
To evaluate baseline physical status of these patients
Instruments: fitness screening tools.
Fitness screening tool: The Short Physical Performance Battery
The short physical performance battery (SPPB). Journal of Biomechanics, Vol. 45, Riskowski JL, Hagedorn TJ, Dufour AB and Hannan MT, Functional foot symmetry and its relation to lower extremity physical performance in older adults: the Framingham Foot Study, pp. 1796–1802
Timepoint [3] 348023 0
Time of baseline interview

Eligibility
Key inclusion criteria
Adult patients diagnosed with colorectal cancer
Scheduled for surgical intervention (cancer resection)
Waiting period of minimum 2 weeks prior to surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Language/communication barrier
Lack of informed consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The initial survey data will be subjected to descriptive statistics. Subsequent logistic regression analysis, as appropriate, to identify the attributes associated with the perceptions of the patients towards the prehabilitation program

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2018
Actual
25/09/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
16/12/2020
Date of last data collection
Anticipated
31/12/2018
Actual
16/12/2020
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11102 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 22914 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 299860 0
Self funded/Unfunded
Name [1] 299860 0
Dr. Usha Gurunathan
Country [1] 299860 0
Australia
Funding source category [2] 299861 0
Self funded/Unfunded
Name [2] 299861 0
Mr. Oystein Tronstad
Country [2] 299861 0
Australia
Funding source category [3] 299862 0
Self funded/Unfunded
Name [3] 299862 0
Dr. Jack Bell
Country [3] 299862 0
Australia
Funding source category [4] 299863 0
Self funded/Unfunded
Name [4] 299863 0
Dr. Christopher Stonell
Country [4] 299863 0
Australia
Funding source category [5] 299864 0
Self funded/Unfunded
Name [5] 299864 0
Dr. Harish Iswariah
Country [5] 299864 0
Australia
Funding source category [6] 299865 0
Self funded/Unfunded
Name [6] 299865 0
Ms. Maria Bello
Country [6] 299865 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland 4032
Country
Australia
Secondary sponsor category [1] 299046 0
Individual
Name [1] 299046 0
Dr. Usha Gurunathan
Address [1] 299046 0
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland 4032
Country [1] 299046 0
Australia
Other collaborator category [1] 280161 0
Individual
Name [1] 280161 0
Mr. Oystein Tronstad
Address [1] 280161 0
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland 4032
Country [1] 280161 0
Australia
Other collaborator category [2] 280162 0
Individual
Name [2] 280162 0
Dr Jack Bell
Address [2] 280162 0
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland 4032
Country [2] 280162 0
Australia
Other collaborator category [3] 280163 0
Individual
Name [3] 280163 0
Dr. Christopher Stonell
Address [3] 280163 0
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland 4032
Country [3] 280163 0
Australia
Other collaborator category [4] 280164 0
Individual
Name [4] 280164 0
Dr. Harish Iswariah
Address [4] 280164 0
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland 4032
Country [4] 280164 0
Australia
Other collaborator category [5] 280165 0
Individual
Name [5] 280165 0
Ms. Maria Bello
Address [5] 280165 0
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland 4032
Country [5] 280165 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300602 0
The Prince Charles Hospital Human Research Ethics Committe
Ethics committee address [1] 300602 0
The Prince Charles Hospital
Building 114
627 Rode Road
Chermside
Queensland 4032
Ethics committee country [1] 300602 0
Australia
Date submitted for ethics approval [1] 300602 0
05/04/2018
Approval date [1] 300602 0
19/04/2018
Ethics approval number [1] 300602 0
HREC/18/QPCH/114 HREC/18/QPCH/114

Summary
Brief summary
This preliminary survey will determine the baseline characteristics and preferences for prehabilitation in patients schedule for colorectal cancer resection.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with colorectal cancer and scheduled for surgical resection.

Study details
“Surgical prehabilitation” is the process of making an individual as fit as they can be, before an operation so that they can better tolerate the stress of surgery. Surgical prehabilitation includes exercise, improving nutritional status and psychological counselling with an intention to increase your strength before surgery. Studies have shown that increasing fitness can reduce complications following bowel surgery. We are looking to design a prehabilitation programme for cancer patients at the Prince Charles Hospital.
To do that, we would like to know the health condition and fitness levels of the patients. We also want to know your preferences for such a programme. We believe that if we have this information, at a later date, we could design a programme that could be easily followed by the future patients. This is only a preliminary survey
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84182 0
Dr Usha Gurunathan
Address 84182 0
The Prince Charles Hospital
Rode Road
Chermside
Queensland 4032
Country 84182 0
Australia
Phone 84182 0
+61 7 3139 4648
Fax 84182 0
Email 84182 0
[email protected]
Contact person for public queries
Name 84183 0
Dr Usha Gurunathan
Address 84183 0
The Prince Charles Hospital
Rode Road
Chermside
Queensland 4032
Country 84183 0
Australia
Phone 84183 0
+61 7 3139 4648
Fax 84183 0
Email 84183 0
[email protected]
Contact person for scientific queries
Name 84184 0
Dr Usha Gurunathan
Address 84184 0
The Prince Charles Hospital
Rode Road
Chermside
Queensland 4032
Country 84184 0
Australia
Phone 84184 0
+61 7 3139 4648
Fax 84184 0
Email 84184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized raw data
When will data be available (start and end dates)?
Upon publication of manuscript and for 5 years from that date.
Available to whom?
Available to researchers who request
Available for what types of analyses?
Raw data available for secondary analysis or other reasonable uses determined by the PI.
How or where can data be obtained?
Upon request to authors by email to PI: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo These findings build on the limited available lite... [More Details]

Documents added automatically
No additional documents have been identified.