PRIORITY-CONNECT 2 Trial

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.

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.

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.

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).

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.

Pain (NPRS)

The Numeric Pain Rating Scale (NPRS) is a widely used tool for assessing pain intensity in individuals. It is a segmented numeric scale where respondents select a whole number (0-10) that best reflects their pain intensity. The scale ranges from 0, indicating "no pain," to 10, representing "the worst pain imaginable." This method allows for a straightforward and quantifiable measure of pain, facilitating communication between patients and healthcare providers.

Exercise capacity (30sSTS)

30 seconds Sit-to-Stand Test (30sSTS) is a reliable and valid tool in evaluating functional exercise capacity in patients.The 30sSTS the performance of as many sit-to-stand actions as possible in 30 seconds without upper limb involvement.

Self-reported physical activity (IPAQ-SF)

International Physical Activity Questionnaire short form (IPAQ-SF) measures the types of intensity of physical activity and sitting time that people do as part of their daily lives. The questionnaire asks participants to report any physical activity (performed for at least 10 minutes) during the last seven days reported as hours per day, minutes per day, and days per week. This aims to be an estimate of total physical activity. IPAQ-SF has demonstrated high reliability and validity.

Nutritional Status (PG-SGA SF)

Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) includes four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function).