PRIORITY-CONNECT 2 Pilot Trial

• ClinicalTrials.gov Identifier: NCT06212700
• Recruitment Status: Recruiting
• First Posted: January 19, 2024
• Last Update Posted: April 25, 2024
• Sponsor: Surgical Outcomes Research Centre (SOuRCe)
• Information provided by (Responsible Party): Surgical Outcomes Research Centre (SOuRCe)

Tracking Information

• First Submitted Date: December 13, 2023
• First Posted Date: January 19, 2024
• Last Update Posted Date: April 25, 2024
• Actual Study Start Date: February 12, 2024
• Estimated Primary Completion Date: July 22, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 8, 2024)

• Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates [ Time Frame: through study completion, an average of 1 year ]
  Feasibility will be determined by the following outcomes: (i) Number of eligible participants recruited to the pilot trial; (ii) Retention rate: defined as the percentage of participants who completed the trial; (iii) Adherence rates: defined as the percentage of planned sessions attended by those who were randomised to the intervention group.
• Acceptability of the virtual multimodal hub. [ Time Frame: 3 months, through study completion, an average of 1 year ]
  Patients, clinicians and carers acceptability to the virtual multimodal hub (Intervention) will be assessed with a semi-structured questionnaire administered at 3-months (last survey). The semi- structured questionnaire contains 11 questions and participants (Patients, clinicians and carers) will be instructed to use a 5-point Likert Scale to express how much they agree or disagree with each statement. In addition, patients will be asked how satisfied they were with the virtual multimodal program and if the program negatively affected them. The investigators have also taken the opportunity to seek further feedback about the virtual multimodal hub (open ended question). The questionnaire has been used on previous pilot trials.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 8, 2024)

• Postoperative complications within 30 days after surgery [ Time Frame: 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 gastrointestinal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and gastrointestinal cancer treatment costs.
• Quality of life outcome EORTC QLQ-C30 [ Time Frame: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery. ]
  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 QoL. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal 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 / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
• Quality of life outcome EORTC QLQ-OG25 [ Time Frame: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery. ]
  EORTC QLQ-OG25 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 25-item tool measuring function and symptoms specific to oesophoago-gastric cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal 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 / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
• Quality of life outcome EORTC QLQ-CR29 [ Time Frame: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery. ]
  EORTC QLQ-CR29 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 29-item tool measuring function and symptoms specific to colorectal cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal 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 / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
• Number of days at home within 30 and 90 days of surgery [ Time Frame: days at home within 30 and 90 days of surgery ]
  DAH-30, 90 (days at home 30, 90): 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 - reduced by complications, discharge to a care facility, re-admission, and death is quantified as the days alive and at home during the 30 days after surgery. DAH-30, 90 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0).
• Resource use [ Time Frame: 1-6 weeks prior to surgery to 3 months post index surgery. ]
  (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 3 months post index surgery.
• Implementation Outcome: Reach [ Time Frame: through study completion, an average of 1 year ]
  RE-AIM Framework, including: Reach: Measured through trial participation, baseline characteristics (referral pathways, age, postcode, marital, work status, and Culturally And Linguistically Diverse [CALD]) of all potential participants.
• Implementation Outcome: Effectiveness [ Time Frame: through study completion, an average of 1 year ]
  RE-AIM Framework, including: Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.
• Implementation Outcome: Adoption [ Time Frame: through study completion, an average of 1 year ]
  RE-AIM Framework, including: Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention).
• Implementation Outcome: Implementation [ Time Frame: through study completion, an average of 1 year ]
  RE-AIM Framework, including: Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol.
• Implementation Outcome: Maintenance [ Time Frame: through study completion, an average of 1 year ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PRIORITY-CONNECT 2 Pilot Trial
• Official Title: Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial

Brief Summary

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications.

Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care.

The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised Type I Hybrid Effectiveness-Implementation Trial

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Consenting participants will undergo baseline assessment immediately prior to randomisation to intervention (virtual multimodal hub and usual care) or control group (usual care alone). The randomisation sequence will be prepared a priori using a central secure randomisation service (1:1 allocation ratio in random permuted blocks of sizes 4 or 2 stratified by hospital, to ensure balance intreatment assignment within hospital) to ensure concealment of treatment allocation and blinding of surgeon, all trial personnel and statistician. Due to the nature of the intervention, it is not possible to blind the clinicians delivering the intervention (virtual multimodal hub); however, the investigators will ensure that all patients' interactions are standardised.

Primary Purpose: Supportive Care

Condition

• Liver Cancer
• Pancreas Cancer
• Oesophageal Cancer
• Gastric Cancer
• Colorectal Cancer

Intervention

• Behavioral: Preoperative Exercise
  Aerobic (HIIT) Endurance Respiratory Muscle Strength Education
• Behavioral: Postoperative Exercise
  Aerobic Muscle Strength Walking Program 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
  Comorbidities Managing pain Wound care Complications Surgical education ERAS
• Other: Postoperative Nursing
  Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education
• Other: Preoperative Peer Support Group

  Weekly sessions moderated by a social worker including patients and carers:

  Safe space Share experiences/ideas Support Education

• Other: Postoperative Peer Support Group

  Weekly sessions moderated by a social worker including patients and carers:

  Safe space Share experiences/ideas Support Education

• Other: Usual Care
  Participants allocated to the control group 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.

Study Arms

• Experimental: Virtual Multimodal Hub and usual care (Intervention Group)
  The main aim of the virtual multimodal hub is to prepare participants for surgery (including the role of Enhanced Recovery after Surgery (ERAS) pathway) and support declines in physiological and psychological function associated with preoperative treatments (e.g., chemo-radiotherapy) and major surgery. The post-hospital discharge interventions will focus on the recovery of activities of daily living, occupational tasks, and recreational activities. Aided by standardised assessment tools, a comprehensive holistic baseline (first preoperative multimodal session) and post-discharge (first postoperative multimodal session) assessment of patients' physical, nutritional, psychological and overall health status, presence of co-morbidities and medical history will determine the frequency, intensity, time, type, volume, and progression of the multimodal interventions.
  Interventions:

  • Behavioral: Preoperative Exercise
  • Behavioral: Postoperative Exercise
  • Dietary Supplement: Preoperative Nutrition
  • Dietary Supplement: Postoperative Nutrition
  • Behavioral: Preoperative Psychology
  • Behavioral: Postoperative Psychology
  • Other: Preoperative Nursing
  • Other: Postoperative Nursing
  • Other: Preoperative Peer Support Group
  • Other: Postoperative Peer Support Group
  • Other: Usual Care
• Active Comparator: Usual care alone (Control Group)
  Participants allocated to the control group 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. Participants will be asked to maintain their normal daily activities.
  Intervention: Other: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 8, 2024): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 22, 2025
• Estimated Primary Completion Date: July 22, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adults aged ≥18 years undergoing major gastrointestinal elective surgery, including liver, pancreas, oesophagus, gastric and colorectal cancer resections with curative intent
• Consulting with a gastrointestinal cancer surgeon at least 1 week prior to scheduled surgery

Exclusion Criteria:

• Cognitive impairment such that they are unable to provide informed consent
• No access to a smart device (including mobile phone, tablet, laptop or desk computer with camera) or no internet connection

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Daniel Steffens, PhD; +61 02 9515 3203; Daniel.Steffens@health.nsw.gov.au

• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT06212700
• Other Study ID Numbers: X23-0399
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Surgical Outcomes Research Centre (SOuRCe)
• Original Responsible Party: Same as current
• Current Study Sponsor: Surgical Outcomes Research Centre (SOuRCe)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Surgical Outcomes Research Centre (SOuRCe)
• Verification Date: April 2024