Colorectal CancerPC2NCT06976710
PRIORITY-CONNECT 2 Trial
A study testing Preoperative Exercise, Postoperative Exercise and Preoperative Nutrition in people with Colorectal Cancer and Colorectal Neoplasms, run by Surgical Outcomes Research Centre (SOuRCe) at 31 sites in Australia.
Trial summary
Objectives: The primary aim of this project is to establish the effectiveness of an individualised stepped, multidisciplinary intervention, including education and peer support group, delivered via a virtual multimodal (p)rehabilitation hub, in reducing postoperative complications within 30-days following colorectal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- Preoperative Exercise, Postoperative Exercise and Preoperative Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 31 sitesAustralia
- Study dates
- 15 Oct 2025to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent
- Consulting with a colorectal cancer surgeon at least 1 week prior to scheduled surgery
Who cannot join
- Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease
- Cognitive impairment such that they are unable to provide informed consent
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
Australia31 sites, 31 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Tarik Sammour
Tracy Fitzsimmons
- Not yet recruiting
Flinders Medical Centre
Adelaide, South Australia, 5042
Dayan De Fontgalland
- Recruiting
Modbury Hospital
Adelaide, South Australia, 5092
Elizabeth Murphy
Hoang Van
- Recruiting
Lyell McEwin Hospital
Adelaide, South Australia, 5112
Elizabeth Murphy
Hoang Van
- Recruiting
Grampians Health Ballarat Hospital
Ballarat, Victoria, 3350
Fernando Arduini
Natasha Brice
- Recruiting
Bendigo Health
Bendigo, Victoria, 3550
Angus Lee
Kate Booth
- Recruiting
Royal Brisbane & Women's Hospital
Brisbane, Queensland, 4029
David Clark
- Not yet recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Chris Gillespie
Natalie Mazzeo
- Not yet recruiting
The Queen Elizabeth II Jubilee Hospital
Brisbane, Queensland, 4108
Chris Gillespie
- Recruiting
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
Andrew Sutherland
- Recruiting
University Hospital Geelong (Barwon Health)
Geelong, Victoria, 3220
Douglas Stupart
Anne Vandewater
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Bernard Riedel
Joanne Shafer
- Not yet recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Joseph Kong
- Recruiting
Footscray Hospital
Melbourne, Victoria, 3011
Justin Yeung
Howard Tang
- Not yet recruiting
Werribee Mercy Hospital
Melbourne, Victoria, 3030
Toan Pham
Tess Asgill
- Not yet recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Jacob McCormick
- Not yet recruiting
St Vincent's Melbourne Hospital
Melbourne, Victoria, 3065
Corina Behrenbruch
James Keck
- Recruiting
Northern Hospital Epping
Melbourne, Victoria, 3076
Basil D'Souza
Andrea Ditoro
- Not yet recruiting
Austin Hospital
Melbourne, Victoria, 3084
Helen Mohan
- Not yet recruiting
Eastern (Box Hill) Hospital
Melbourne, Victoria, 3128
Vinna An
Wei Ming
- Not yet recruiting
Cabrini Hospital
Melbourne, Victoria, 3144
Joseph Kong
- Not yet recruiting
Calvary Mater Hospital
Newcastle, New South Wales, 2298
Stephen Smith
- Not yet recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
Stephen Smith
- Not yet recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Vicki Patton
- Recruiting
Chris O'Brien Lifehouse
Sydney, New South Wales, 2050
Michael Solomon
- Recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Daniel Steffens, PhD, +61 02 9515 3203, Daniel.Steffens@health.nsw.gov.au
- Not yet recruiting
Concord Repatriation General Hospital
Sydney, New South Wales, 2139
Michael Suen
Yanlan Lin
- Not yet recruiting
Westmead Hospital
Sydney, New South Wales, 2145
Amy Cao
- Not yet recruiting
Blacktown Hospital
Sydney, New South Wales, 2148
Rajni Lal
Danette Wright
- Not yet recruiting
Wagga Wagga Base Hospital
Wagga Wagga, New South Wales, 2650
Stephen Jancewicz
- Not yet recruiting
Wollongong Hospital
Wollongong, New South Wales, 2500
Robert Winn
Andrew Still
About this study
Official title: Virtual Multimodal Hub for Patients Undergoing Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial
Objectives:
The primary aim of this project is to establish the effectiveness of an individualised stepped, multidisciplinary intervention, including education and peer support group, delivered via a virtual multimodal (p)rehabilitation hub, in reducing postoperative complications within 30-days following colorectal cancer surgery, compared to usual care alone.
Read more
The secondary aims will be to obtain data on the likely difference in key outcomes including:
(i) Quality of life (EORTC QLQ-C30 and QLQ-CR29) (ii) Number of days at home within 30, 90 and 365 days after surgery (DAH-30, 90, 365) (iii) Quality of recovery (QoR-15) (iv) Cost-effectiveness (v) Implementation metrics (RE-AIM)
Our hypothesis is that the PRIORITY-CONNECT 2 intervention will be more effective in reducing postoperative complications and more cost-effective than usual care.
Study design:
Pragmatic Randomised Type I Hybrid Effectiveness-Implementation Trial.
Planned sample size:
To achieve the primary aim, 564 participants will provide 90% power to detect a 15% difference in 30-day postoperative complication rates between the intervention and control groups. The sample size calculation accounts for up to 10% loss to follow-up, 5% non-compliance and a two-side alpha of 0.05.
Selection criteria:
A sample of 564 participants undergoing colorectal cancer surgery including open, laparoscopic or robotic-assisted surgery (mostly, anterior resection, sigmoid colectomy, hemicolectomy, total proctocolectomy, subtotal colectomy, total colectomy) at sites throughout Australia will be included. These are common colorectal cancer surgeries performed at the participating centres. All the surgeons involved in this study have clinical appointments in their respective hospitals.
Inclusion: Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent; and consulting a colorectal surgeon at least 1 week prior to scheduled surgery.
Exclusion: Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease; or cognitive impairment such that they are unable to provide informed consent.
Study Procedure:
Participant's treating team will screen and provide an information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). The intervention will include the delivery of usual care and evidence-based exercise, nutritional, psychological and nursing interventions, and / or group-delivered peer support. All interventions will be conducted before and after surgery.
Duration of the Study:
Approximately 60 months.
Funding:
Medical Research Future Fund (MRFF) 2023 Early and Mid-Career Researchers (Application ID: 2031563).
Sponsor:
The University of Sydney.
Read the detailed description
Further details on the study procedures:
Patients will be identified by their treating team (including but not limited to colorectal surgeon, allied health, research and nursing staff). The treating team will screen and provide the information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). Patients will undergo an immediate second randomisation to determine their virtual hub assignment (Royal Prince Alfred Hospital Hub or The Peter MacCallum Cancer Centre Hub).
The participants randomised into the intervention group will then be contacted by a range of allied health workers, depending on their individual needs. These may include a physiotherapist, dietitian, psychologist, nurse and/ or a social worker. The intervention will provide the participants support as they navigate the health system. These health workers will communicate with them via the virtual hub for sessions to provide support before surgery and help with their recovery. Participant's individual needs will determine the frequency, intensity, time, type, volume, and progression of these sessions. This intervention may last for up to 12 months after their surgery, but they will be discharged from the intervention once they have reached their treatment goals. If participants do not have access to a smart device and/or internet, the investigators can provide them with a tablet with internet connectivity to engage in virtual delivery of sessions.
Data and safety monitoring:
An independent Data and Safety Monitoring Board (DSMB), will be monitored by a multidisciplinary panel (including statistician(s)). This panel will assess for adverse events and adherence to the protocol at regular intervals to ensure the safety of participants. The frequency of DSMB meetings and the stopping rules for the study will be defined a priori in a charter, in consultation with the DSMB members and study investigators. This will include after commencing participant recruitment and once one fourth of participants have been recruited.
ProCoMida:
The PRO CoMiDa form is a data management tool, designed to provide standardised documentation of the completion, or reasons for non-completion, of patient reported outcomes assessments by patients in a clinical trial. Such documentation is crucial for quality assurance since missing data is the greatest threat to the integrity and interpretability of patient reported outcomes data. The PRO CoMiDa form must be completed at each scheduled patient reported outcomes assessment.
GCP Certificates:
The trial will conform to all relevant ICH GCP guidelines and regulations. Annual audits will be conducted by research officers to ensure that all study staff maintain current GCP certification.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Preoperative Exercise, Postoperative Exercise, Preoperative Nutrition, Postoperative Nutrition, Preoperative Psychology
- Keywords
- Prehabilitation, Colorectal Cancer, Surgery, Surgical Outcomes, Randomised Controlled Trial, Virtual Rehabilitation, Virtual Prehabilitation, Multidisciplinary, Virtual Care, Rehabilitation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative ExerciseBehavioural
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Postoperative ExerciseBehavioural
Aerobic, Endurance, Respiratory, Muscle Strength, Education
Preoperative NutritionDietary supplement
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Postoperative NutritionDietary supplement
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
Preoperative PsychologyBehavioural
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
Postoperative PsychologyBehavioural
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education
Preoperative NursingOther
Risk management, Managing pain, Wound care, Bowel function, Surgical education
Postoperative NursingOther
Risk management, Managing pain, Wound care, Bowel function/Stoma management, Education
Preoperative Peer Support GroupBehavioural
Fortnightly sessions moderated by a social worker including patients and carers:
Safe space, Share experiences/ideas, Support, Education
Postoperative Peer Support GroupBehavioural
Fortnightly sessions moderated by a social worker including patients and carers:
Safe space, Share experiences/ideas, Support, Education
Usual CareOther
All participants will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Multimodal Hub and usual care (Intervention Group) | Experimental | The intervention is a multicomponent virtual hub which encompasses medical, social, psychological and functional assessment(s) and intervention(s). Following a comprehensive holistic assessment, clinicians will tailor the intervention subject to individual's presentation and needs. This may include evidence-based exercise, nutritional, psychological and nursing interventions, and /or group-delivered peer support, in addition to usual care. Adjustments and progression will be made in each session according to an individual's response. All interventions will be conducted before and after surgery.
Standardised assessment tools will guide the frequency, intensity, duration, type, volume, and progression of the multimodal interventions, with the potential for the intervention(s) to be stepped-up or stepped-down based on individual patient needs Receives: Behavioral: Preoperative Exercise; Behavioral: Postoperative Exercise; Dietary Supplement: Preoperative Nutrition; Dietary Supplement: Postoperative Nutrition; Behavioral: Preoperative Psychology; Behavioral: Postoperative Psychology; Other: Preoperative Nursing; Other: Postoperative Nursing; Behavioral: Preoperative Peer Support Group; Behavioral: Postoperative Peer Support Group; Other: Usual Care |
| Usual care alone (Control Group) | Active comparator | Participants allocated to the control group will only receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits. Participants will be asked to maintain their normal daily activities. No attempt will be made to alter the routine care pathway. The use of any additional service will be recorded to inform the comprehensive cost analysis (linked to PBS and MBS data). Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants developing postoperative complications within 30 days after surgery.
The primary outcome will be the proportion of participants developing postoperative complications within 30 days after surgery, defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. The risk of developing complications following colorectal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and colorectal cancer treatment costs.
Measured: First 30-days after surgery
Secondary outcomes (5)
Quality of Life Outcome (EORTC QLQ-C30 and QLQ-CR29)
The European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) are validated, cancer-specific tools commonly used to assess quality of life in colorectal cancer patients. The QLQ-C30 includes 30 items assessing five functional domains, nine symptom scales, financial impact and overall quality of life. The QLQ-CR29 is a 29-item tool to evaluate symptoms (gastrointestinal, urinary, pain and others) and functional areas (sexual, body image and others) that are associated with colorectal cancer and its treatments. Both tools use scales ranging from 0 to 100. Higher scores on functional and global health scales reflect better functioning or quality of life, whereas higher scores on symptom scales indicate greater symptom burden or problems.
Measured: Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Quality of Recovery (QoR-15)
The QoR-15 is a validated tool designed to assess the quality of recovery after surgery. It consists of 15 items rated on an 11-point numerical rating scale ranging from 0 to 10. The overall QoR-15 score is calculated by summing all individual item scores, resulting in a total score ranging from 0 to 150, where higher scores indicate a better quality of recovery. Recovery will be defined as return to baseline values or better in each of the questions or assessments.
Measured: Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Number of days at home within 30, 90 and 365 days of surgery (DAH-30, 90, 365)
Validated (Australian-population) patient-centred outcome metrics that integrates length of hospital stay, discharge destination (other than home), hospital readmission and early death. The number of days at home is reduced by, for example, complications elongating acute hospital bed stay, discharge to a care facility, re-admission, and death. This is quantified as the days alive and at home during the 30 days after surgery. Days at home is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0).
Measured: Days at home within 30, 90 and 365 days of index surgery
Resource use (costs)
Patient and health system resource use, including the cost of the virtual multimodal hub interventions, hospitalisations, will be collected (surveys) from randomisation (1-6 weeks prior to surgery) to 12 months post index surgery.
Measured: Measured at baseline, 1, 3, 6 and 12 months post index surgery.
Implementation metrics: (RE-AIM)
The framework is used to plan, evaluate and assess the impact of a variety of health care and prevention programs. Elements assessed: Reach: Proportion of eligible patients recruited into the study, alongside the baseline characteristics (referral pathways, age, postcode, marital, work status, and cultural and linguistic diversity) of all potential participants. Effectiveness: Clinical outcomes, healthcare utilisation, and participant satisfaction (measured both quantitatively and qualitatively). Adoption: Referral rates, enablers and barriers (collected post intervention from patients, carers, surgeons, clinical and administrative staff). Implementation: Centre level - implementation process (patients, carers, and clinical staff interviews and direct observation), concordance with intervention protocol. Maintenance: referral rates and stakeholder interviews to identify refinements and infrastructure needed to maintain and scale intervention beyond the project period.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 Oct 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surgical Outcomes Research Centre (SOuRCe)
- Sponsor type
- Research network
- Collaborators
- University of Sydney, Medical Research Future Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976710
- Sponsor's protocol ID
- X23-0399 Phase 2
- Acronym
- PC2
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following explicit informed consent from individual participants, any de-identified data will be shared for studies approved by both the Principal Investigator (A/Prof Daniel Steffens) and a NHRMC approved Human Research Ethics Committee (HREC).
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Multimodal Hub for Patients Undergoing Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT06976710
- Acronym / sponsor ID
- PC2 / X23-0399 Phase 2
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Keywords
- Prehabilitation, Colorectal Cancer, Surgery, Surgical Outcomes, Randomised Controlled Trial, Virtual Rehabilitation, Virtual Prehabilitation, Multidisciplinary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Surgical Outcomes Research Centre (SOuRCe)Research network
- Collaborators
- University of Sydney, Medical Research Future Fund
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
The primary aim of this project is to establish the effectiveness of an individualised stepped, multidisciplinary intervention, including education and peer support group, delivered via a virtual multimodal (p)rehabilitation hub, in reducing postoperative complications within 30-days following colorectal cancer surgery, compared to usual care alone.
The secondary aims will be to obtain data on the likely difference in key outcomes including:
(i) Quality of life (EORTC QLQ-C30 and QLQ-CR29) (ii) Number of days at home within 30, 90 and 365 days after surgery (DAH-30, 90, 365) (iii) Quality of recovery (QoR-15) (iv) Cost-effectiveness (v) Implementation metrics (RE-AIM)
Our hypothesis is that the PRIORITY-CONNECT 2 intervention will be more effective in reducing postoperative complications and more cost-effective than usual care.
Study design:
Pragmatic Randomised Type I Hybrid Effectiveness-Implementation Trial.
Planned sample size:
To achieve the primary aim, 564 participants will provide 90% power to detect a 15% difference in 30-day postoperative complication rates between the intervention and control groups. The sample size calculation accounts for up to 10% loss to follow-up, 5% non-compliance and a two-side alpha of 0.05.
Selection criteria:
A sample of 564 participants undergoing colorectal cancer surgery including open, laparoscopic or robotic-assisted surgery (mostly, anterior resection, sigmoid colectomy, hemicolectomy, total proctocolectomy, subtotal colectomy, total colectomy) at sites throughout Australia will be included. These are common colorectal cancer surgeries performed at the participating centres. All the surgeons involved in this study have clinical appointments in their respective hospitals.
Inclusion: Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent; and consulting a colorectal surgeon at least 1 week prior to scheduled surgery.
Exclusion: Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease; or cognitive impairment such that they are unable to provide informed consent.
Study Procedure:
Participant's treating team will screen and provide an information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). The intervention will include the delivery of usual care and evidence-based exercise, nutritional, psychological and nursing interventions, and / or group-delivered peer support. All interventions will be conducted before and after surgery.
Duration of the Study:
Approximately 60 months.
Funding:
Medical Research Future Fund (MRFF) 2023 Early and Mid-Career Researchers (Application ID: 2031563).
Sponsor:
The University of Sydney.
Detailed description
Further details on the study procedures:
Patients will be identified by their treating team (including but not limited to colorectal surgeon, allied health, research and nursing staff). The treating team will screen and provide the information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). Patients will undergo an immediate second randomisation to determine their virtual hub assignment (Royal Prince Alfred Hospital Hub or The Peter MacCallum Cancer Centre Hub).
The participants randomised into the intervention group will then be contacted by a range of allied health workers, depending on their individual needs. These may include a physiotherapist, dietitian, psychologist, nurse and/ or a social worker. The intervention will provide the participants support as they navigate the health system. These health workers will communicate with them via the virtual hub for sessions to provide support before surgery and help with their recovery. Participant's individual needs will determine the frequency, intensity, time, type, volume, and progression of these sessions. This intervention may last for up to 12 months after their surgery, but they will be discharged from the intervention once they have reached their treatment goals. If participants do not have access to a smart device and/or internet, the investigators can provide them with a tablet with internet connectivity to engage in virtual delivery of sessions.
Data and safety monitoring:
An independent Data and Safety Monitoring Board (DSMB), will be monitored by a multidisciplinary panel (including statistician(s)). This panel will assess for adverse events and adherence to the protocol at regular intervals to ensure the safety of participants. The frequency of DSMB meetings and the stopping rules for the study will be defined a priori in a charter, in consultation with the DSMB members and study investigators. This will include after commencing participant recruitment and once one fourth of participants have been recruited.
ProCoMida:
The PRO CoMiDa form is a data management tool, designed to provide standardised documentation of the completion, or reasons for non-completion, of patient reported outcomes assessments by patients in a clinical trial. Such documentation is crucial for quality assurance since missing data is the greatest threat to the integrity and interpretability of patient reported outcomes data. The PRO CoMiDa form must be completed at each scheduled patient reported outcomes assessment.
GCP Certificates:
The trial will conform to all relevant ICH GCP guidelines and regulations. Annual audits will be conducted by research officers to ensure that all study staff maintain current GCP certification.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Multimodal Hub and usual care (Intervention Group) | Experimental | Behavioral: Preoperative Exercise, Behavioral: Postoperative Exercise, Dietary Supplement: Preoperative Nutrition, Dietary Supplement: Postoperative Nutrition, Behavioral: Preoperative Psychology, Behavioral: Postoperative Psychology, Other: Preoperative Nursing, Other: Postoperative Nursing, Behavioral: Preoperative Peer Support Group, Behavioral: Postoperative Peer Support Group, Other: Usual CareThe intervention is a multicomponent virtual hub which encompasses medical, social, psychological and functional assessment(s) and intervention(s). Following a comprehensive holistic assessment, clinicians will tailor the intervention subject to individual's presentation and needs. This may include evidence-based exercise, nutritional, psychological and nursing interventions, and /or group-delivered peer support, in addition to usual care. Adjustments and progression will be made in each session according to an individual's response. All interventions will be conducted before and after surgery. Standardised assessment tools will guide the frequency, intensity, duration, type, volume, and progression of the multimodal interventions, with the potential for the intervention(s) to be stepped-up or stepped-down based on individual patient needs |
| Usual care alone (Control Group) | Active comparator | Other: Usual CareParticipants allocated to the control group will only receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits. Participants will be asked to maintain their normal daily activities. No attempt will be made to alter the routine care pathway. The use of any additional service will be recorded to inform the comprehensive cost analysis (linked to PBS and MBS data). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent
- Consulting with a colorectal cancer surgeon at least 1 week prior to scheduled surgery
Key exclusion criteria (2 listed)
- Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease
- Cognitive impairment such that they are unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative ExerciseAerobic, Endurance, Respiratory, Muscle Strength, Education | Behavioural | Virtual Multimodal Hub and usual care (Intervention Group) |
| Postoperative ExerciseAerobic, Endurance, Respiratory, Muscle Strength, Education | Behavioural | Virtual Multimodal Hub and usual care (Intervention Group) |
| Preoperative NutritionMalnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support | Dietary supplement | Virtual Multimodal Hub and usual care (Intervention Group) |
| Postoperative NutritionMalnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support | Dietary supplement | Virtual Multimodal Hub and usual care (Intervention Group) |
| Preoperative PsychologyCBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education | Behavioural | Virtual Multimodal Hub and usual care (Intervention Group) |
| Postoperative PsychologyCBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education | Behavioural | Virtual Multimodal Hub and usual care (Intervention Group) |
| Preoperative NursingRisk management, Managing pain, Wound care, Bowel function, Surgical education | Other | Virtual Multimodal Hub and usual care (Intervention Group) |
| Postoperative NursingRisk management, Managing pain, Wound care, Bowel function/Stoma management, Education | Other | Virtual Multimodal Hub and usual care (Intervention Group) |
| Preoperative Peer Support GroupFortnightly sessions moderated by a social worker including patients and carers: Safe space, Share experiences/ideas, Support, Education | Behavioural | Virtual Multimodal Hub and usual care (Intervention Group) |
| Postoperative Peer Support GroupFortnightly sessions moderated by a social worker including patients and carers: Safe space, Share experiences/ideas, Support, Education | Behavioural | Virtual Multimodal Hub and usual care (Intervention Group) |
| Usual CareAll participants will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits. | Other | Usual care alone (Control Group), Virtual Multimodal Hub and usual care (Intervention Group) |
Primary outcome
Proportion of participants developing postoperative complications within 30 days after surgery.
Time frame: First 30-days after surgery
The primary outcome will be the proportion of participants developing postoperative complications within 30 days after surgery, defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. The risk of developing complications following colorectal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and colorectal cancer treatment costs.
5 secondary outcomes
Quality of Life Outcome (EORTC QLQ-C30 and QLQ-CR29)
Time frame: Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Quality of Recovery (QoR-15)
Time frame: Measured at baseline, 1-2 day(s) before surgery, perioperative (within 1 day of hospital discharge), 1, 3, 6 and 12 months post index surgery.
Number of days at home within 30, 90 and 365 days of surgery (DAH-30, 90, 365)
Time frame: Days at home within 30, 90 and 365 days of index surgery
Resource use (costs)
Time frame: Measured at baseline, 1, 3, 6 and 12 months post index surgery.
Implementation metrics: (RE-AIM)
Time frame: Through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. Following explicit informed consent from individual participants, any de-identified data will be shared for studies approved by both the Principal Investigator (A/Prof Daniel Steffens) and a NHRMC approved Human Research Ethics Committee (HREC).
Related trials for Colorectal Cancer
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Exercise, Postoperative Exercise and Preoperative Nutrition in people with Colorectal Cancer and Colorectal Neoplasms, run by Surgical Outcomes Research Centre (SOuRCe) at 31 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Steffens, PhD (+61 02 9515 3203, Daniel.Steffens@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants developing postoperative complications within 30 days after surgery. (time frame: First 30-days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.