Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000409976
Ethics application status
Approved
Date submitted
20/12/2019
Date registered
27/03/2020
Date last updated
27/03/2020
Date data sharing statement initially provided
27/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prehabilitation for Gastrointestinal Cancer Surgery
Scientific title
Implementation study looking to see if a multimodal (exercise, nutrition and nursing support) prehabiliation program for Patients with gastrointestinal cancer (colorectal and upper gastrointestinal) undergoing curative intent surgery can be built into routine care and its impact on length of stay and post-operative complications.


Secondary ID [1] 300150 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PREHAB-GI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Cancer 315678 0
Gastrointestinal cancer Surgery 315685 0
Physical inactivity 315686 0
Condition category
Condition code
Cancer 314877 314877 0 0
Bowel - Anal
Cancer 314878 314878 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 314879 314879 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 314880 314880 0 0
Liver
Cancer 314881 314881 0 0
Oesophageal (gullet)
Cancer 314882 314882 0 0
Pancreatic
Cancer 314883 314883 0 0
Stomach
Physical Medicine / Rehabilitation 314884 314884 0 0
Other physical medicine / rehabilitation
Surgery 314885 314885 0 0
Other surgery
Diet and Nutrition 314896 314896 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will commence from time of preadmission clinic assessment or direct screening from the surgeon’s rooms, allowing for a duration of 2-4 weeks.
The prehabilitation intervention will consist of
1. Exercise:
Consisting of one-two supervised, tailored 60-minute group-based exercise sessions per week delivered by an accredited exercise physiologist at the Survivorship Gym, Concord Hospital. Exercise sessions will be a combination of aerobic (AET) and resistance (RET) exercise training ranging from low, moderate to vigorous intensity. AET may include the use of a cycle ergometer, treadmill, elliptical and/or rowing machine. Target intensity of AET is 60-75% of heart rate reserve. Selection of apparatus will be dependent on participant preference and capability. RET will be of large muscle groups and use body weight, hand weights and/or cable machine exercises, e.g. bicep curls, shoulder press, bench press, push ups and sit-ups. Heart rate and Rating of Perceived Exertion (RPE) will be recorded throughout each session along with the intensity. Attendance to the exercise sessions will be recorded.

Participants will be advised to participate in a home-based AET program tailored to their baseline ability. The target is to walk, cycle, and/or swim (dependent on preference) on (at least) three other days per week and to increase each bout of exercise to build up to a total of 30 minutes of home-based aerobic exercise (walking/cycling/swimming etc) on at least three days/week prior to their surgery. Participants will be provided with an exercise diary to capture the duration, intensity and type of activity.

2. Nutrition:
Nutrition assessment and dietary advice (1 x 60 minutes total) will be provided by an accredited practicing dietitian at baseline. Dietary advice will be given focusing on meeting protein requirements (1.2-1.5g/kg per body weight or adjusted body weight in obese patients as per ESPEN guidelines) using food models and an inhouse developed written resource about healthy eating and protein foods. Patients who have additional dietary support needs (i.e. nutrition-related symptoms: bowels, nausea, loss of appetite; malnutrition), will have further individualised nutrition care plans and education as determined by the dietitian and/or their clinical team. Adherence to the dietary information will be measured using a 3-day food record for 2 weekdays and 1 weekend day, completed prior to commencing the intervention and repeated before the pre-surgical assessment. Participants were required to measure and record the quantity of all foods and beverages consumed, using standard household measures.

Participants will be provided with oral high protein nutritional supplements (Fresubin® Protein Energy Drink 200ml) containing 20g protein and 300kcal, and recommended to be consumed daily within one-hour post exercise to capitalise on muscle synthesis (anabolic window), from day 1 until two days prior to surgery. Supplement intake and timing after exercise will be recorded in the patient diary and any unconsumed oral high protein supplements returned to monitor adherence.

3. Nursing support:
One (15-20 minute) nurse-led phone support session per week of intervention.
Intervention code [1] 316420 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322376 0
Adoption of the prehabilitation program. This will be measured through multiple (composite) endpoints such as referral data into the program via data linkage and logs, clinician satisfaction measured using a in-house developed evolution questionnaire to the medical team and nurses.

Timepoint [1] 322376 0
End of study duration, approximately 12 months.
Primary outcome [2] 322377 0
Reach (number, proportion, and representativeness) of individuals who are willing to participate in the prehabiliation program. This will be measured through multiple (composite) endpoints such as participation rates among eligible patients using the screening logs, and participant characteristics including demographics, tumour type, functionality (and comparison to non-participants) obtained through medical records.
Timepoint [2] 322377 0
End of study duration, approximately 12 months.
Primary outcome [3] 322378 0
Implementation of the prehabiliation program. This will be measured through multiple (composite) endpoints such as completion rates, withdrawal rates and reasons through screening logs; and adherence to exercise sessions, nurse calls and nutrition intervention through exercise and supplement diary, gym attendance, and completion of evaluations.
Timepoint [3] 322378 0
End of study duration, approximately 12 months.
Secondary outcome [1] 378255 0
Length of hospital stay, assessed using medical records.
Timepoint [1] 378255 0
Time of discharge from hospital
Secondary outcome [2] 378256 0
Functional status, measured through multiple (composite) outcomes such as, 6 minute walk test (6MWT), 2-minute step test, handgrip strength using hand dynamometer, 30-second chair stand.
Timepoint [2] 378256 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [3] 378257 0
Exercise behaviour: measured through multiple (composite) endpoints such as Godin Leisure time exercise questionnaire and participant exercise log.
Timepoint [3] 378257 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [4] 378258 0
Quality of Life:European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30).
Timepoint [4] 378258 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [5] 378259 0
Fatigue – Functional Assessment Cancer Therapy – Fatigue (FACIT-F) subscale.
Timepoint [5] 378259 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [6] 378260 0
Mood measured by the National Comprehensive Cancer Network Distress Thermometer
Timepoint [6] 378260 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [7] 378261 0
Anxiety and depression: measured by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [7] 378261 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [8] 378262 0
Nutritional status, measured using composite endpoints such as the Patient-Generated Subjective Global Assessment (PG-SGA) and sarcopenia screening tool (SARC-F.)
Timepoint [8] 378262 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [9] 378263 0
Anthropometrics measured through multiple (composite) outcomes: weight (kg) using the Seca® mBCA 515 Analyser, height measured using a stadiometer (cm), BMI calculated using weight/height squared (kg/m2), body composition (fat mass, fat free mass, skeletal muscle mass, visceral adiposity) using a bioelectrical impedance analysis (BIA) (The Seca® mBCA 515 Analyser [Seca®, Hamburg, Germany]), and waist circumference using a tape measure.
Timepoint [9] 378263 0
Baseline, Post intervention (1-4 days prior to surgery) and 30 days post surgery date
Secondary outcome [10] 378264 0
Complications: surgical intra-operative, and 30-day post-operative, Clavien-Dindo Grading determined using patient medical records. Complications can include gastrointestinal bleed, anastomotic leak, ileus, wound infection, sepsis.
Timepoint [10] 378264 0
baseline and 30 days post surgery date
Secondary outcome [11] 378265 0
Adverse events using the NCI CTCAE v5.0
Possible adverse events include HEMORRHAGE/BLEEDING, INFECTION, CARDIAC ARRHYTHMIA, ILEUS, OBSTRUCTION, DEATH.
Timepoint [11] 378265 0
30 days post surgery.
Secondary outcome [12] 378267 0
Patient satisfaction/experience with the prehabiliation program using in-house developed survey.
Timepoint [12] 378267 0
Post intervention (1-4 days prior to surgery) and 30 days post surgery date

Eligibility
Key inclusion criteria
• Aged at least 18 years.
• Pre-operative clinical staging confirmed stage I-III colorectal or upper GI cancer, or limited stage IV CRC (e.g. limited liver metastases planned for resection) or upper GI cancer that is potentially curable with surgery.
• Elective colorectal cancer or upper gastrointestinal resection scheduled greater than 14 days after time of referral to study.
• Medical clearance for exercise.
• Willing to attend supervised exercise sessions 1-2 per week until surgery.
• European Co-operative Oncology Group (ECOG)26 performance status of 0-2.
• Willing to complete patient-reported outcome questionnaires and exercise/dietary logs.
• Willing to take prescribed high protein supplements until surgery.
• Agreeable to follow up for 30-days post-surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to do exercise or take nutritional supplement for physical or medical reasons.
• Unable to give informed consent or follow instructions due to cognitive difficulties.
• Currently undergoing neoadjuvant chemotherapy or radiotherapy. (Patients will be eligible for participation on completion of neoadjuvant chemo/radiotherapy providing there is at least 14 days before surgery).

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome based on the RE-AIM Evaluation framework will be reported descriptively, with an a priori focus on referral, recruitment and retention targets.
Secondary endpoints that report changes in outcome variables from baseline (Week 0) to post-intervention (pre-surgery) will be measured using mixed models. Along with Exploratory evaluation of post-surgery outcome variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/01/2020
Date of last participant enrolment
Anticipated
28/12/2020
Actual
Date of last data collection
Anticipated
31/01/2021
Actual
Sample size
Target
100
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15552 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 28923 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 304584 0
Commercial sector/Industry
Name [1] 304584 0
Bendigo bank - Homebush Branch
Country [1] 304584 0
Australia
Funding source category [2] 304587 0
Other Collaborative groups
Name [2] 304587 0
Fresenius Kabi
Country [2] 304587 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Concord Repatriation General Hospital
Hospital Rd, Concord, NSW, 2139

Country
Australia
Secondary sponsor category [1] 304874 0
None
Name [1] 304874 0
Address [1] 304874 0
Country [1] 304874 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305010 0
Sydney Local Health District HREC Concord Repatriation General Hospital
Ethics committee address [1] 305010 0
Concord Repatriation General Hospital (CRGH)
Concord NSW 2139
Ethics committee country [1] 305010 0
Australia
Date submitted for ethics approval [1] 305010 0
14/08/2019
Approval date [1] 305010 0
15/11/2019
Ethics approval number [1] 305010 0
CH62/6/2019-114

Summary
Brief summary
The purpose of this study is to determine if a multimodal (exercise, nutrition and nursings support) prehabilitation program for patient undergoing major gastrointestinal cancer surgery for curative intent can be built into routine care.

Who is it for?
Patients with stage I-III or limited stage IV colorectal or upper gastrointestinal cancer undergoing curative intent surgery at concord repatriation general hospital.

Study Details

The study will involve both an exercise and diet program 2-4 weeks prior to major gastrointestinal surgery. All participants will receive the intervention.
1.Exercise:
The exercise component will involve supervised and tailored 60-minute group-based exercise sessions per week using a combination of resistance and aerobic exercises delivered by an accredited exercise physiologist. In addition, 3 x homebased exercise training.
2. Nutrition:
The nutritional component will involve Oral high protein supplements (Fresubin® Protein Energy) containing 20g protein, recommended to be consumed daily within one-hour post exercise to capitalize on muscle synthesis (day one until two days prior to surgery). In addition, nutritional advice will be provided delivered by a dietitian to achieve adequate oral protein intake.
3.Nursing support:
One (15-20 minute) nurse-led phone support session per week of intervention Assessment
Involvement in the study will involve a variety of body measurements and questionnaires, including questions about quality of life and patient satisfaction.

It is hoped this study will further insight into how prehabilitation can decrease length of stay, lead to better surgical outcomes, whilst evaluating the change in functional, nutritional and psychological status.
Trial website
nil
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 98954 0
Prof Janette vardy
Address 98954 0
Concord Cancer Centre, Concord Repatriation General Hospital
Hospital Rd, Concord, NSW, 2139
Country 98954 0
Australia
Phone 98954 0
+612 9767 5000
Fax 98954 0
+612 9767 7934
Email 98954 0
[email protected]
Contact person for public queries
Name 98955 0
Prof Janette vardy
Address 98955 0
Concord Cancer Centre, Concord Repatriation General Hospital
Hospital Rd, Concord, NSW, 2139
Country 98955 0
Australia
Phone 98955 0
+612 9767 5000
Fax 98955 0
+612 9767 7934
Email 98955 0
[email protected]
Contact person for scientific queries
Name 98956 0
Prof Janette vardy
Address 98956 0
Concord Cancer Centre, Concord Repatriation General Hospital
Hospital Rd, Concord, NSW, 2139
Country 98956 0
Australia
Phone 98956 0
+612 9767 5000
Fax 98956 0
+612 9767 7934
Email 98956 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
For ethical reasons IPD will not be available


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.