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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06976710




Registration number
NCT06976710
Ethics application status
Date submitted
13/04/2025
Date registered
16/05/2025

Titles & IDs
Public title
PRIORITY-CONNECT 2 Trial
Scientific title
Virtual Multimodal Hub for Patients Undergoing Major Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial
Secondary ID [1] 0 0
X23-0399 Phase 2
Universal Trial Number (UTN)
Trial acronym
PC2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Preoperative Exercise
BEHAVIORAL - Postoperative Exercise
Treatment: Other - Preoperative Nutrition
Treatment: Other - Postoperative Nutrition
BEHAVIORAL - Preoperative Psychology
BEHAVIORAL - Postoperative Psychology
Other interventions - Preoperative Nursing
Other interventions - Postoperative Nursing
BEHAVIORAL - Preoperative Peer Support Group
BEHAVIORAL - Postoperative Peer Support Group
Other interventions - Usual Care

Experimental: Virtual Multimodal Hub and usual care (Intervention Group) - 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

Active comparator: Usual care alone (Control Group) - 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).


BEHAVIORAL: Preoperative Exercise
Aerobic, Endurance, Respiratory, Muscle Strength, Education

BEHAVIORAL: Postoperative Exercise
Aerobic, Endurance, Respiratory, Muscle Strength, Education

Treatment: Other: Preoperative Nutrition
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support

Treatment: Other: Postoperative Nutrition
Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support

BEHAVIORAL: Preoperative Psychology
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education

BEHAVIORAL: Postoperative Psychology
CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education

Other interventions: Preoperative Nursing
Risk management, Managing pain, Wound care, Bowel function, Surgical education

Other interventions: Postoperative Nursing
Risk management, Managing pain, Wound care, Bowel function/Stoma management, Education

BEHAVIORAL: Preoperative Peer Support Group
Fortnightly sessions moderated by a social worker including patients and carers:

Safe space, Share experiences/ideas, Support, Education

BEHAVIORAL: Postoperative Peer Support Group
Fortnightly sessions moderated by a social worker including patients and carers:

Safe space, Share experiences/ideas, Support, Education

Other interventions: Usual Care
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.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants developing postoperative complications within 30 days after surgery.
Timepoint [1] 0 0
First 30-days after surgery
Secondary outcome [1] 0 0
Quality of life outcome EORTC QLQ-C30
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Quality of life outcome EORTC QLQ-CR29
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Quality of Recovery (QoR-15)
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Number of days at home within 30, 90 and 365 days of surgery (DAH-30, 90, 365)
Timepoint [4] 0 0
Days at home within 30, 90 and 365 days of index surgery
Secondary outcome [5] 0 0
Resource use (costs)
Timepoint [5] 0 0
Measured at baseline, 1, 3, 6 and 12 months post index surgery.
Secondary outcome [6] 0 0
Implementation outcome: Reach
Timepoint [6] 0 0
Through study completion, an average of 12 months
Secondary outcome [7] 0 0
Implementation outcome: Effectiveness (quantitative and qualitative questionnaires)
Timepoint [7] 0 0
Through study completion, an average of 12 months
Secondary outcome [8] 0 0
Implementation outcome: Adoption (quantitative and qualitative measures)
Timepoint [8] 0 0
Through study completion, an average of 12 months
Secondary outcome [9] 0 0
Implementation outcome: Implementation (quantitative and qualitative measures)
Timepoint [9] 0 0
Through study completion, an average of 12 months
Secondary outcome [10] 0 0
Implementation outcome: Maintenance
Timepoint [10] 0 0
Through study completion, an average of 12 months
Secondary outcome [11] 0 0
Pain (NPRS)
Timepoint [11] 0 0
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.
Secondary outcome [12] 0 0
Exercise capacity (30sSTS)
Timepoint [12] 0 0
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.
Secondary outcome [13] 0 0
Self-reported physical activity (IPAQ-SF)
Timepoint [13] 0 0
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.
Secondary outcome [14] 0 0
Nutritional Status (PG-SGA SF)
Timepoint [14] 0 0
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.
Secondary outcome [15] 0 0
Anxiety (GAD-7)
Timepoint [15] 0 0
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.
Secondary outcome [16] 0 0
Depression (PHQ-9)
Timepoint [16] 0 0
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.
Secondary outcome [17] 0 0
Fear of cancer recurrence (FCR-1r)
Timepoint [17] 0 0
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.
Secondary outcome [18] 0 0
Adverse events (NHMRC Safety Monitoring and Reporting of Clinical Trials)
Timepoint [18] 0 0
From date of opening recruitment to date of trial close-out
Secondary outcome [19] 0 0
Self-efficacy (GSE)
Timepoint [19] 0 0
Measured at 1, 3, 6 and 12 months post index surgery.
Secondary outcome [20] 0 0
Treatment & Health Services
Timepoint [20] 0 0
Measured at 1, 3, 6 and 12 months post index surgery.
Secondary outcome [21] 0 0
Satisfaction & Experience
Timepoint [21] 0 0
Measured at 1, 3, 6 and 12 months post index surgery.
Secondary outcome [22] 0 0
Return to work
Timepoint [22] 0 0
Measured between 1 and 12 months post index surgery.

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cognitive impairment such that they are unable to provide informed consent

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
564
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Calvary Mater Hospital - Newcastle
Recruitment hospital [3] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [4] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [7] 0 0
Westmead Hospital - Sydney
Recruitment hospital [8] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [9] 0 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [10] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [11] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [13] 0 0
The Queen Elizabeth II Jubilee Hospital - Brisbane
Recruitment hospital [14] 0 0
Cairns Hospital - Cairns
Recruitment hospital [15] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [16] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [17] 0 0
Modbury Hospital - Adelaide
Recruitment hospital [18] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [19] 0 0
Grampians Health Ballarat Hospital - Ballarat
Recruitment hospital [20] 0 0
Bendigo Health - Bendigo
Recruitment hospital [21] 0 0
University Hospital Geelong (Barwon Health) - Geelong
Recruitment hospital [22] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [23] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [24] 0 0
Footscray Hospital - Melbourne
Recruitment hospital [25] 0 0
Werribee Mercy Hospital - Melbourne
Recruitment hospital [26] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [27] 0 0
St Vincent's Melbourne Hospital - Melbourne
Recruitment hospital [28] 0 0
Northern Hospital Epping - Melbourne
Recruitment hospital [29] 0 0
Austin Hospital - Melbourne
Recruitment hospital [30] 0 0
Eastern (Box Hill) Hospital - Melbourne
Recruitment hospital [31] 0 0
Cabrini Hospital - Melbourne
Recruitment hospital [32] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2305 - Newcastle
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2139 - Sydney
Recruitment postcode(s) [6] 0 0
2145 - Sydney
Recruitment postcode(s) [7] 0 0
2148 - Sydney
Recruitment postcode(s) [8] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [9] 0 0
2500 - Wollongong
Recruitment postcode(s) [10] 0 0
4029 - Brisbane
Recruitment postcode(s) [11] 0 0
4102 - Brisbane
Recruitment postcode(s) [12] 0 0
4108 - Brisbane
Recruitment postcode(s) [13] 0 0
4870 - Cairns
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
Recruitment postcode(s) [15] 0 0
5042 - Adelaide
Recruitment postcode(s) [16] 0 0
5092 - Adelaide
Recruitment postcode(s) [17] 0 0
5112 - Adelaide
Recruitment postcode(s) [18] 0 0
3350 - Ballarat
Recruitment postcode(s) [19] 0 0
3550 - Bendigo
Recruitment postcode(s) [20] 0 0
3220 - Geelong
Recruitment postcode(s) [21] 0 0
3000 - Melbourne
Recruitment postcode(s) [22] 0 0
3004 - Melbourne
Recruitment postcode(s) [23] 0 0
3011 - Melbourne
Recruitment postcode(s) [24] 0 0
3030 - Melbourne
Recruitment postcode(s) [25] 0 0
3050 - Melbourne
Recruitment postcode(s) [26] 0 0
3065 - Melbourne
Recruitment postcode(s) [27] 0 0
3076 - Melbourne
Recruitment postcode(s) [28] 0 0
3084 - Melbourne
Recruitment postcode(s) [29] 0 0
3128 - Melbourne
Recruitment postcode(s) [30] 0 0
3144 - Melbourne
Recruitment postcode(s) [31] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Surgical Outcomes Research Centre (SOuRCe)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Sydney, Sydney, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniel Steffens, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 02 9515 3203
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06976710