PRIORITY-CONNECT 2 Trial

Official title

Virtual Multimodal Hub for Patients Undergoing Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial

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.

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.

Interventions

• Behavioral Preoperative Exercise
  Aerobic, Endurance, Respiratory, Muscle Strength, Education
• Behavioral Postoperative Exercise
  Aerobic, Endurance, Respiratory, Muscle Strength, Education
• Dietary supplement Preoperative Nutrition
  Malnutrition screening, Weight monitoring, Symptom management, Dietetic counselling, Nutrition support
• Dietary supplement 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 Preoperative Nursing
  Risk management, Managing pain, Wound care, Bowel function, Surgical education
• Other 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

Primary outcome measures

• Proportion of participants developing postoperative complications within 30 days after surgery. [Time frame: First 30-days after surgery]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Australia · 31 centers

• Coffs Harbour Health Campus — Coffs Harbour
• Calvary Mater Hospital — Newcastle
• John Hunter Hospital — Newcastle
• Chris O'Brien Lifehouse — Sydney
• Royal Prince Alfred Hospital — Sydney
• Concord Repatriation General Hospital — Sydney
• Westmead Hospital — Sydney
• Blacktown Hospital — Sydney
• … and 23 more centers

Identifiers

NCT: NCT06976710 · X23-0399 Phase 2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗