PRIORITY-CONNECT 2 Trial

Surgical Outcomes Research Centre (SOuRCe)564 enrolled

Overview

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.

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.

Interventions

Preoperative ExerciseBEHAVIORAL

Aerobic, Endurance, Respiratory, Muscle Strength, Education

Postoperative ExerciseBEHAVIORAL

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 PsychologyBEHAVIORAL

CBT skills, Skills training, Emotional validation, Behavioural activation, Psycho-education

Postoperative PsychologyBEHAVIORAL

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 GroupBEHAVIORAL

Fortnightly sessions moderated by a social worker including patients and carers: Safe space, Share experiences/ideas, Support, Education

Postoperative Peer Support GroupBEHAVIORAL

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.

Locations (31)

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia

RECRUITING

Calvary Mater Hospital

Newcastle, New South Wales, Australia

NOT_YET_RECRUITING

John Hunter Hospital

Newcastle, New South Wales, Australia

NOT_YET_RECRUITING

Chris O'Brien Lifehouse

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

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.

Time frame: First 30-days after surgery

Secondary Outcomes

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.

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)

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.

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)

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).

Time frame: 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.

Time frame: 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.

Time frame: Through study completion, an average of 12 months