AzTrials
AzTrials

Liver CancerNCT06212700

PRIORITY-CONNECT 2 Pilot Trial

A study testing Preoperative Exercise, Postoperative Exercise and Preoperative Nutrition in people with Liver Cancer and Pancreas Cancer, run by Surgical Outcomes Research Centre (SOuRCe) at 2 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer, Pancreas Cancer, Oesophageal Cancer
What is being tested?
Preoperative Exercise, Postoperative Exercise and Preoperative Nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesAustralia
Study dates
12 Feb 2024to 22 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Daniel Steffens, PhD contact

+61 02 9515 3203

Daniel.Steffens@health.nsw.gov.au

Australia2 sites, 2 recruiting

  • Chris O'Brien Lifehouse

    Sydney, New South Wales, 2050

    Michael Solomon, DMed, +61 02 95153200, professor.solomon@sydney.edu.au

    Recruiting

  • Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe)

    Sydney, New South Wales, 2050

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

    Recruiting

Other trials in Australia

About this study

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

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.

Being tested
Preoperative Exercise, Postoperative Exercise, Preoperative Nutrition, Postoperative Nutrition, Preoperative Psychology
Keywords
Prehabilitation, Gastrointestinal cancer, Surgery, Surgical outcomes, Randomised controlled trial
Medical subject headings
Liver Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative ExerciseBehavioural

    Aerobic (HIIT) Endurance Respiratory Muscle Strength Education

  • Postoperative ExerciseBehavioural

    Aerobic Muscle Strength Walking Program 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 PsychologyBehavioural

    CBT skills Skills training Emotional validation Behavioural activation Psycho-education

  • Postoperative PsychologyBehavioural

    CBT skills Skills training Emotional validation Behavioural activation Psycho-education

  • Preoperative NursingOther

    Comorbidities Managing pain Wound care Complications Surgical education ERAS

  • Postoperative NursingOther

    Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education

  • Preoperative Peer Support GroupOther

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

    Safe space Share experiences/ideas Support Education

  • Postoperative Peer Support GroupOther

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

    Safe space Share experiences/ideas Support Education

  • Usual CareOther

    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 groups in NCT06212700
Study groupRoleWhat they receive
Virtual Multimodal Hub and usual care (Intervention Group)ExperimentalThe 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.
Receives: 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
Usual care alone (Control Group)Active comparatorParticipants 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.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates

    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.

    Measured: through study completion, an average of 1 year

  2. Acceptability of the virtual multimodal hub.

    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.

    Measured: 3 months, through study completion, an average of 1 year

Secondary outcomes (11)

  1. 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 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.

    Measured: 30 days after surgery

  2. Quality of life outcome EORTC QLQ-C30

    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.

    Measured: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.

  3. Quality of life outcome EORTC QLQ-OG25

    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.

    Measured: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.

  4. Quality of life outcome EORTC QLQ-CR29

    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.

    Measured: Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.

  5. Number of 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).

    Measured: days at home within 30 and 90 days of surgery

  6. 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 3 months post index surgery.

    Measured: 1-6 weeks prior to surgery to 3 months post index surgery.

  7. Implementation Outcome: Reach

    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.

    Measured: through study completion, an average of 1 year

  8. Implementation Outcome: Effectiveness

    RE-AIM Framework, including:

    Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.

    Measured: through study completion, an average of 1 year

  9. Implementation Outcome: Adoption

    RE-AIM Framework, including:

    Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention).

    Measured: through study completion, an average of 1 year

  10. Implementation Outcome: Implementation

    RE-AIM Framework, including:

    Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol.

    Measured: through study completion, an average of 1 year

  11. Implementation Outcome: Maintenance

    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.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start12 Feb 2024
  3. Primary completion22 Jul 2025 (estimated)
  4. Study completion22 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised Type I Hybrid Effectiveness-Implementation Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06212700
Sponsor's protocol ID
X23-0399
Status last verified
Apr 2024
First submitted
13 Dec 2023
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reeves J, Koh C, Smith AB, Mohan H, Carey S, Smith S, Poulton T, Patton V, White K, Laranjo L, Dieng M, Liu X, Denehy L, Wilson K, Allman-Farinelli M, Butow P, Riedel B, Morton RL, Hassett L, Li Q, Delbaere K, Martin O, Dhillon HM, Shailer B, Beardsworth G, Salter M, Cherry K, Rubie F, Reece L, Chan A, Shahab R, Dwyer O, Pring K, Cunningham D, Sheehan K, Iori G, Johnander R, Jeon C, Hirst N, Karunaratne S, Zhou A, Hutchings O, Solomon M, Steffens D; PRIORITY-CONNECT Collaborators. Acceptability and Feasibility of a Virtual Multimodal (P)Rehabilitation Programme for Gastrointestinal Cancer Patients: The PRIORITY-CONNECT 2 Pilot Randomised Controlled Trial. Ann Surg Oncol. 2026 Jun;33(6):5739-5750. doi: 10.1245/s10434-026-19355-0. Epub 2026 Mar 14.

    PubMed 41832362

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative Exercise, Postoperative Exercise and Preoperative Nutrition in people with Liver Cancer and Pancreas Cancer, run by Surgical Outcomes Research Centre (SOuRCe) at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniel Steffens, PhD (+61 02 9515 3203, Daniel.Steffens@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06212700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in