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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
Date last updated
16/05/2025
Titles & IDs
Public title
PRIORITY-CONNECT 2 Trial
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Scientific title
Virtual Multimodal Hub for Patients Undergoing Major Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial
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Secondary ID [1]
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X23-0399 Phase 2
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Universal Trial Number (UTN)
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Trial acronym
PC2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Colorectal Neoplasms
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants developing postoperative complications within 30 days after surgery.
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Assessment method [1]
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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.
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Timepoint [1]
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First 30-days after surgery
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Secondary outcome [1]
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Quality of life outcome EORTC QLQ-C30
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Assessment method [1]
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EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item cancer-specific tool measuring five functioning scales, nine symptom scales, financial impact and overall quality of life. This tool is a common (excellent reliability and validity) quality of life tool for colorectal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems
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Timepoint [1]
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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.
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Secondary outcome [2]
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Quality of life outcome EORTC QLQ-CR29
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Assessment method [2]
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EORTC QLQ-CR29 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) 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. This tool is a common (excellent reliability and validity) quality of life tool for colorectal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
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Timepoint [2]
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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.
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Secondary outcome [3]
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Quality of Recovery (QoR-15)
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Assessment method [3]
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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.
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Timepoint [3]
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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.
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Secondary outcome [4]
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Number of days at home within 30, 90 and 365 days of surgery (DAH-30, 90, 365)
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Assessment method [4]
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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).
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Timepoint [4]
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Days at home within 30, 90 and 365 days of index surgery
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Secondary outcome [5]
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Resource use (costs)
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Assessment method [5]
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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.
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Timepoint [5]
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Measured at baseline, 1, 3, 6 and 12 months post index surgery.
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Secondary outcome [6]
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Implementation outcome: Reach
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Assessment method [6]
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RE-AIM Framework, including: Reach: Measured through proportion of eligible patients recruited into the study, baseline characteristics (referral pathways, age, postcode, marital, work status, and, cultural and linguistic diversity) of all potential participants.
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Timepoint [6]
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Through study completion, an average of 12 months
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Secondary outcome [7]
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Implementation outcome: Effectiveness (quantitative and qualitative questionnaires)
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Assessment method [7]
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RE-AIM Framework, including: Effectiveness: Measured patient reported satisfaction questionnaires using a 5-point Likert scale from extremely dissatisfied to extremely satisfied and qualitative feedback via questionnaires and/or interviews with participants.
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Timepoint [7]
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Through study completion, an average of 12 months
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Secondary outcome [8]
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Implementation outcome: Adoption (quantitative and qualitative measures)
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Assessment method [8]
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RE-AIM Framework, including: Adoption: Measured through referral rates (frequency and number of patients screened per site), and qualitative interviews with patients, carers, surgeons, clinical and administrative staff post intervention to determine enablers and barriers to adoption.
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Timepoint [8]
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Through study completion, an average of 12 months
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Secondary outcome [9]
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Implementation outcome: Implementation (quantitative and qualitative measures)
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Assessment method [9]
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RE-AIM Framework, including: Implementation: measured through individual level: Participant adherence to virtual intervention measured as number of sessions attended compared to number of sessions recommended and/or scheduled.
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Timepoint [9]
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Through study completion, an average of 12 months
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Secondary outcome [10]
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Implementation outcome: Maintenance
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Assessment method [10]
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RE-AIM Framework, including: Maintenance: Measured through rates of referral over time of the study; stakeholder interviews regarding refinements and infrastructure needed to maintain and scale intervention beyond the project period.
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Timepoint [10]
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Through study completion, an average of 12 months
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Secondary outcome [11]
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Pain (NPRS)
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Assessment method [11]
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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.
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Timepoint [11]
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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.
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Secondary outcome [12]
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Exercise capacity (30sSTS)
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Assessment method [12]
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30 seconds Sit-to-Stand Test (30sSTS) is a reliable and valid tool in evaluating functional exercise capacity in patients.The 30sSTS involves an armless chair and the performance of as many sit-to-stand actions as possible in 30 seconds without upper limb involvement.
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Timepoint [12]
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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.
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Secondary outcome [13]
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Self-reported physical activity (IPAQ-SF)
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Assessment method [13]
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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.
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Timepoint [13]
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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.
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Secondary outcome [14]
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Nutritional Status (PG-SGA SF)
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Assessment method [14]
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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).
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Timepoint [14]
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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.
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Secondary outcome [15]
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Anxiety (GAD-7)
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Assessment method [15]
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General Anxiety Disorder-7 (GAD-7) is a self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
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Timepoint [15]
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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.
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Secondary outcome [16]
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Depression (PHQ-9)
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Assessment method [16]
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Patient Health Questionnaire-9 (PHQ-9) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 is used to monitor the severity of depression and response to treatment.
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Timepoint [16]
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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.
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Secondary outcome [17]
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Fear of cancer recurrence (FCR-1r)
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Assessment method [17]
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Fear of cancer recurrence (FCR-1r) is a single-item screening measure for fear of cancer recurrence.The FCR-1r is a valid tool for FCR screening in colorectal cancer survivors with excellent ability to discriminate between clinical and non-clinical fear of cancer recurrence.
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Timepoint [17]
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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.
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Secondary outcome [18]
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Adverse events (NHMRC Safety Monitoring and Reporting of Clinical Trials)
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Assessment method [18]
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The NHMRC publication Safety monitoring and reporting in clinical trials involving therapeutic goods sets out the requirements for the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials.
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Timepoint [18]
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From date of opening recruitment to date of trial close-out
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Secondary outcome [19]
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Self-efficacy (GSE)
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Assessment method [19]
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General Self-Efficacy Scale (GSE) is a self-reported measure of self-efficacy.The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction.The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
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Timepoint [19]
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Measured at 1, 3, 6 and 12 months post index surgery.
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Secondary outcome [20]
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Treatment & Health Services
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Assessment method [20]
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Data on postoperative treatment and health service utilisation including instance of treatment received, number of diagnostic imaging, number of GP/specialists visits, number of emergency department visits, number of hospital readmissions, number of support services received, hours of paid and unpaid work performed.
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Timepoint [20]
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Measured at 1, 3, 6 and 12 months post index surgery.
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Secondary outcome [21]
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Satisfaction & Experience
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Assessment method [21]
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Self-reported questionnaire asking participants to answer questions regarding their level of satisfaction with various components of the intervention reported on a 5-point Likert scale from extremely dissatisfied to extremely staisfied. Moreover, satisfaction feedback regarding the program, barriers and facilitators for future implementation will be obtained through interviews with clinicians, patients and caregivers at the end of the study period.
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Timepoint [21]
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Measured at 1, 3, 6 and 12 months post index surgery.
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Secondary outcome [22]
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Return to work
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Assessment method [22]
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Safe Work Australia reports will be accessed to obtain return to work information.
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Timepoint [22]
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Measured between 1 and 12 months post index surgery.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Cognitive impairment such that they are unable to provide informed consent
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2028
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Actual
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Sample size
Target
564
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Coffs Harbour Health Campus - Coffs Harbour
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Recruitment hospital [2]
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Calvary Mater Hospital - Newcastle
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Recruitment hospital [3]
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John Hunter Hospital - Newcastle
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Recruitment hospital [4]
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0
Chris O'Brien Lifehouse - Sydney
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Recruitment hospital [5]
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0
Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [6]
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0
Concord Repatriation General Hospital - Sydney
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Recruitment hospital [7]
0
0
Westmead Hospital - Sydney
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Recruitment hospital [8]
0
0
Blacktown Hospital - Sydney
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Recruitment hospital [9]
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0
Wagga Wagga Base Hospital - Wagga Wagga
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Recruitment hospital [10]
0
0
Wollongong Hospital - Wollongong
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Recruitment hospital [11]
0
0
Royal Brisbane & Women's Hospital - Brisbane
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Recruitment hospital [12]
0
0
Princess Alexandra Hospital - Brisbane
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Recruitment hospital [13]
0
0
The Queen Elizabeth II Jubilee Hospital - Brisbane
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Recruitment hospital [14]
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0
Cairns Hospital - Cairns
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Recruitment hospital [15]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [16]
0
0
Flinders Medical Centre - Adelaide
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Recruitment hospital [17]
0
0
Modbury Hospital - Adelaide
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Recruitment hospital [18]
0
0
Lyell McEwin Hospital - Adelaide
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Recruitment hospital [19]
0
0
Grampians Health Ballarat Hospital - Ballarat
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Recruitment hospital [20]
0
0
Bendigo Health - Bendigo
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Recruitment hospital [21]
0
0
University Hospital Geelong (Barwon Health) - Geelong
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Recruitment hospital [22]
0
0
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [23]
0
0
Alfred Hospital - Melbourne
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Recruitment hospital [24]
0
0
Footscray Hospital - Melbourne
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Recruitment hospital [25]
0
0
Werribee Mercy Hospital - Melbourne
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Recruitment hospital [26]
0
0
Royal Melbourne Hospital - Melbourne
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Recruitment hospital [27]
0
0
St Vincent's Melbourne Hospital - Melbourne
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Recruitment hospital [28]
0
0
Northern Hospital Epping - Melbourne
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Recruitment hospital [29]
0
0
Austin Hospital - Melbourne
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Recruitment hospital [30]
0
0
Eastern (Box Hill) Hospital - Melbourne
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Recruitment hospital [31]
0
0
Cabrini Hospital - Melbourne
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Recruitment hospital [32]
0
0
Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
0
0
2450 - Coffs Harbour
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Recruitment postcode(s) [2]
0
0
2298 - Newcastle
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Recruitment postcode(s) [3]
0
0
2305 - Newcastle
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Recruitment postcode(s) [4]
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0
2050 - Sydney
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Recruitment postcode(s) [5]
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0
2139 - Sydney
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Recruitment postcode(s) [6]
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0
2145 - Sydney
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Recruitment postcode(s) [7]
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0
2148 - Sydney
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Recruitment postcode(s) [8]
0
0
2650 - Wagga Wagga
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Recruitment postcode(s) [9]
0
0
2500 - Wollongong
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Recruitment postcode(s) [10]
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0
4029 - Brisbane
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Recruitment postcode(s) [11]
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0
4102 - Brisbane
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Recruitment postcode(s) [12]
0
0
4108 - Brisbane
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Recruitment postcode(s) [13]
0
0
4870 - Cairns
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Recruitment postcode(s) [14]
0
0
5000 - Adelaide
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Recruitment postcode(s) [15]
0
0
5042 - Adelaide
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Recruitment postcode(s) [16]
0
0
5092 - Adelaide
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Recruitment postcode(s) [17]
0
0
5112 - Adelaide
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Recruitment postcode(s) [18]
0
0
3350 - Ballarat
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Recruitment postcode(s) [19]
0
0
3550 - Bendigo
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Recruitment postcode(s) [20]
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0
3220 - Geelong
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Recruitment postcode(s) [21]
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0
3000 - Melbourne
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Recruitment postcode(s) [22]
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0
3004 - Melbourne
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Recruitment postcode(s) [23]
0
0
3011 - Melbourne
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Recruitment postcode(s) [24]
0
0
3030 - Melbourne
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Recruitment postcode(s) [25]
0
0
3050 - Melbourne
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Recruitment postcode(s) [26]
0
0
3065 - Melbourne
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Recruitment postcode(s) [27]
0
0
3076 - Melbourne
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Recruitment postcode(s) [28]
0
0
3084 - Melbourne
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Recruitment postcode(s) [29]
0
0
3128 - Melbourne
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Recruitment postcode(s) [30]
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0
3144 - Melbourne
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Recruitment postcode(s) [31]
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0
6000 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Surgical Outcomes Research Centre (SOuRCe)
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of Sydney, Sydney, Australia
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief 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 (pre)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: 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.
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Trial website
https://clinicaltrials.gov/study/NCT06976710
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Daniel Steffens, PhD
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+61 02 9515 3203
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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).
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
Data will only be made available upon individual request following the completion of the project. It will be at the discretion of the Principal Investigator (A/Prof Daniel Steffens) when this has been achieved. Once available, data may be accessed for up to 15 years after the trial's closure, after which it will be destroyed in accordance with the protocol.
Query!
Available to whom?
Based on explicit consent from individual participants, de-identified individual patient data (IPD) will be made available to researchers who comply with all regulations stipulated by a NHMRC-approved Human Research Ethics Committee (HREC). Subject to the discretion of both the Principal Investigator and a NHMRC-approved HREC, data will be made available for any approved analyses.
Researchers interested in accessing IPD must submit a request to the Principal Investigator, A/Prof Daniel Steffens (
[email protected]
). Mechanisms for data sharing will be in line with the Research Data Management Plan and a transfer process stipulated by a NHRMC approved HREC.
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Available for what types of analyses?
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How or where can data be obtained?
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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
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