Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001067561
Ethics application status
Approved
Date submitted
12/08/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a supportive care navigation tool for people diagnosed with pancreatic cancer
Scientific title
Evaluate the effectiveness of implementing a supportive care navigation tool for people diagnosed with pancreatic cancer.
Secondary ID [1] 312606 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer
 334542 0
unmet needs 334543 0
survival 334544 0
Condition category
Condition code
Cancer 331144 331144 0 0
Pancreatic
Physical Medicine / Rehabilitation 331145 331145 0 0
Other physical medicine / rehabilitation
Public Health 331146 331146 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A co-designed resource and supportive care navigation tool will be embedded in clinical care in Hepatic Pancreatic and Biliary (HPB) Surgical Unit at Flinders Medical Centre. The resource and tool will be co-designed by cancer survivors, carers, allied health staff and the research team. The use and delivery of the resource and supportive care navigation tool will also be decided during the co-design process. The co-design process will commence in August 2024 and expected completion is December 2025.
Participation in the co-design of the information resource and supportive care navigation tool is predicted to involve up to 5 focus group/workshop sessions lasting 1-1.5 hours each over a 5-6 month period. Participants will be asked to provide input regarding identification of survivor/carer information needs (information topics etc.), existing resources including FMC, Flinders University health precinct and SA specific resources, mapping of existing resources to needs identified, identification of preferred resource types (print vs online etc.), and development of new information resources (images, colours, font, layout etc. and satisfaction and usability testing. Cancer survivor participants will also be asked their opinions and preferences regarding how service referrals are made and the timing of the use of the supportive care navigation tool. Surgeons/nurses who will be using the tool will be asked their preferences regarding tool format and referral processes, timing of use and frequency of use.
The resource will be offered to all patients at diagnosis or soon after, and the navigation tool will be used during nursing/surgical consultations to monitor and identify unmet needs, and with patient involvement, facilitate the referral to appropriate supportive care services offered by the hospital, the local university health clinics, and the patient’s general practitioner as appropriate. The supportive care navigation tool will be used during multiple consultations (frequency decided by clinicians and patients), to monitor changing needs and ensure appropriate and timely supportive care referrals.
The tool will include a needs screening component (Distress Thermometer + Checklist) and a service referral component to supportive care services such as nutrition, exercise physiology, psycho-oncology, physiotherapy, legal and social work.
Pancreatic cancer survivor involved in the co-design process will be current or recent (6 month post diagnosis) patients of the Flinders Medical Centre Hepatic Pancreatic and Biliary (HPB) Surgical Unit. Some may have ceased active care with the Hepatic Pancreatic and Biliary (HPB) Surgical Unit. All cancer survivors involved in the co-design process will be provided a copy of the co-designed resource and navigation tool, but they will not be eligible to participate in the implementation trial (i.e. navigation tool used in clinical care).
The implementation (trial) of the resource and navigation tool will involve 8 months of active recruitment and tool use in the surgical unit, and then 6 month and 12 month participant follow up post enrolment. During the 8 month effectiveness implementation trial, the resource will be offered to all patients and the navigation tool use offered to all patients, and consecutive patients diagnosed with pancreatobiliary cancer (who received the resource and tool as part of care) will be approached and invited to participate in the research project. Adherence to the intervention will be monitored as part of the feasibility data collection process via interviews with nurses and surgeons, and also via a log sheet recording resource provision and navigation tool use provided, and reasons for patients resource ad navigation tool decline.
Intervention code [1] 329117 0
Treatment: Other
Comparator / control treatment
Standard care in the Hepatic Pancreatic and Biliary (HPB) Surgical Unit at Flinders Medical Centre as defined for the purpose of this study involves: 1) the surgeon providing several supportive care information brochures 2) and referral to supportive care services based on surgical consultations and actioned by individual surgeons. No processes are embedded to ensure all patients are offered the resources. No structured supportive needs screening occurs and there is no structured supportive care referral procedure in the surgical unit. The control data will be prospectively collected from patients of the
These data will be collected prospectively from pancreatobiliary cancer patients/caregivers of the Hepatic Pancreatic and Biliary (HPB) Surgical Unit at Flinders Medical Centre from September 2024. Active recruitment will continue for a period of 6 months. Participants will then be followup 6 and 12 months post study enrolment. Active recruitment of the control group will close prior to the intervention phase of the study.
Control group
Historical

Outcomes
Primary outcome [1] 338894 0
Effectiveness outcome: Unmet needs
Timepoint [1] 338894 0
Control group: once 1-2 months post diagnosis, 6 months and 12 months post study enrolment
Intervention Group: once 1-2 months post diagnosis, 6 months and 12 months post study enrolment
Primary outcome [2] 338895 0
Survival (reported as 1 year survival rate)
Timepoint [2] 338895 0
Control and Intervention Group: once 6 months and 12 months post study enrolment
Primary outcome [3] 339172 0
Effectiveness outcome: Distress
Timepoint [3] 339172 0
Control group: once 1-2 months post diagnosis, 6 months and 12 months post study enrolment
Intervention Group: once 1-2 months post diagnosis, 6 months and 12 months post study enrolment
Secondary outcome [1] 437826 0
acceptability (cancer survivors/carers)
Timepoint [1] 437826 0
once during 1-2 months post diagnosis
Secondary outcome [2] 437827 0
Feasibility outcome: uptake
Timepoint [2] 437827 0
Plan-Do-Study-Act cycle during 8 months implementation phase. Data collection once at 1 month, 3 months and 6 months of implementation (interviews and log)
Once at the end of the implementation intervention (interview and log)
Secondary outcome [3] 438880 0
Satisfaction (and usefulness) with resource and navigation tool process (cancer survivor/carer)
Timepoint [3] 438880 0
once 1-2 months post diagnosis
Secondary outcome [4] 438881 0
Perceived benefit (cancer survivor/carer)
Timepoint [4] 438881 0
once 1-2 months post diagnosis
Secondary outcome [5] 438882 0
Barriers or issues with use (resource and navigation process) (cancer survivor/carer)
Timepoint [5] 438882 0
Intervention group: once 1-2 months post diagnosis
Secondary outcome [6] 438898 0
Feasibility outcome: Time spent in service delivery (staff)
Timepoint [6] 438898 0
Plan-Do-Study-Act cycle during 8 months implementation phase. Data collection once at 1 month, 3 months and 6 months of implementation
Once at the end of the implementation intervention
Secondary outcome [7] 438899 0
Feasibility outcome: Barriers to use and provision (staff)
Timepoint [7] 438899 0
Plan-Do-Study-Act cycle during 8 months implementation phase. Data collection once at 1 month, 3 months and 6 months of implementation
Once at the end of the implementation intervention
Secondary outcome [8] 438900 0
Feasibility outcome: Satisfaction (staff)
Timepoint [8] 438900 0
Plan-Do-Study-Act cycle during 8 months implementation phase. Data collection once at 1 month, 3 months and 6 months of implementation
Once at the end of the implementation intervention
Secondary outcome [9] 438901 0
Feasibility outcome: Recommendation for improvement (staff)
Timepoint [9] 438901 0
Plan-Do-Study-Act cycle during 8 months implementation phase. Data collection once at 1 month, 3 months and 6 months of implementation
Once at the end of the implementation intervention
Secondary outcome [10] 438902 0
Feasibility outcome: Consistency and fidelity of use (staff)
Timepoint [10] 438902 0
Plan-Do-Study-Act cycle during 8 months implementation phase. Data collection once at 1 month, 3 months and 6 months of implementation
Once at the end of the implementation intervention
Secondary outcome [11] 438903 0
Recommendation for improvement (cancer survivors/carers)
Timepoint [11] 438903 0
Intervention group: once 1-2 months post diagnosis
Secondary outcome [12] 438909 0
Typical supportive care practices (staff)
Timepoint [12] 438909 0
once during control phase data collection period (6 month duration)
Secondary outcome [13] 438910 0
Typical supportive care resource and service use (cancer survivor/carer)
Timepoint [13] 438910 0
Control group: once 1-2 months post diagnosis
Secondary outcome [14] 438911 0
Barriers to supportive care access and use (cancer survivor/carer)
Timepoint [14] 438911 0
Control Group: once 1-2 months post diagnosis
Secondary outcome [15] 438912 0
Experience of supportive care in surgical unit (cancer survivor/carer)
Timepoint [15] 438912 0
Control Group: once 1-2 months post diagnosis

Eligibility
Key inclusion criteria
Control Group (2 participant groups)
1. Participants are required to be current patients in the surgical unit and to have been diagnosed with pancreatobiliary cancer (18yrs+) (confirmed during multidisciplinary team meetings). The carers (18years+) of these patients can also be participants.
2. Hepatic Pancreatic and Biliary surgeons/nurses caring for patients diagnosed with pancreatobiliary cancer at FMC during the implementation phase of the project.
Implementation Intervention (2 participant groups)
1. Participants are required to be current patients in the surgical unit and to have been diagnosed with pancreatobiliary cancer (18years+) (confirmed during multidisciplinary team meeting) who have experienced the resource and navigation tool. The carers (18yrs+) of these patients can also be participants.
2. Hepatic Pancreatic and Biliary surgeons/nurses caring for patients diagnosed with pancreatobiliary cancer at FMC during the implementation phase of the project.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Control data will be collected prior to the implementation intervention. The collection of control data (effectiveness and implementation) prior to the single group effectiveness-implementation trial enables the rapid implementation of the co-designed resource and navigation tool as soon as practicable into clinical care and eliminates the need for withholding an intervention that is expected to provide benefit to people diagnosed with pancreatic cancer.
Control group: For a period of 6 months, consecutive patients (18 years and older) diagnosed with pancreatic cancer in the HPB surgical unit are being invited to participate. Expected recruitment August 2024-January 2025.
Intervention Group: Once the co-designed resource and supportive care navigation tool is developed, for a period of 8 months, consecutive patients (18 years and older) diagnosed with pancreatic cancer (confirmed at multidisciplinary team meeting) in the HPB surgical unit at Flinders Medical Centre who have experienced the resource and tool will be invited to participate. Expected recruitment to commence March 2025.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative effectiveness outcomes will be reported using descriptive statistics (means (95%CIs) and medians (95% IQR)) and differences between intervention and control groups will be explored using z-test (survival rates), t-test and Pearson's ?2 test.
Quantitative implementation outcomes will be reported using descriptive statistics (frequencies, means (95%Cis) and medians (95% IQR)).
Interviews will be transcribed verbatim and analysed using narrative content analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2024
Actual
Date of last participant enrolment
Anticipated
24/11/2025
Actual
Date of last data collection
Anticipated
23/11/2026
Actual
Sample size
Target
95
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26848 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 42910 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 317035 0
Charities/Societies/Foundations
Name [1] 317035 0
Flinders Foundation
Country [1] 317035 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Country
Australia
Secondary sponsor category [1] 319282 0
University
Name [1] 319282 0
Flinders University
Address [1] 319282 0
Country [1] 319282 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315792 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 315792 0
https://www.sahealth.sa.gov.au/wps/wcm/connect/Public%2BContent/SA%2BHealth%2BInternet/About%2Bus/Our%2BLocal%2BHealth%2BNetworks/Southern%2BAdelaide%2BLocal%2BHealth%2BNetwork/Research/For%2BResearchers/Southern%2BAdelaide%2BClinical%2BHuman%2BResearch%2BEthics%2BCommittee
Ethics committee country [1] 315792 0
Australia
Date submitted for ethics approval [1] 315792 0
16/04/2024
Approval date [1] 315792 0
12/07/2024
Ethics approval number [1] 315792 0
76.24

Summary
Brief summary
Control Phase
This study aims to understand the needs, resource and supportive care service use and to understand the current supportive care referral practices of the surgical unit.
You may be eligible for this study if you are a male or female age 18 or older in the surgical unit and diagnosed with pancreaticobiliary cancer or carer of the patient who meets this condition. You can also participate if you are a Hepatic Pancreatic and Biliary surgeon/nurse caring for patients diagnosed with pancreatobiliary cancer at Flinders Medical Centre.
Study details
As a cancer survivor/carer, you will be involved in 1 interview (30-45 minutes). During the interview, you will be asked about your cancer-related needs, resource and supportive care service access. You will also be asked to fill out 2 cancer-related needs surveys (Supportive Care Needs Survey Short Form 34, Distress Thermometer). You will also participate in a phone conversation that is expected to take 15 minutes, 6 months, and 12 months after enrolling in the study. During the phone call, you will be asked to complete the 2 cancer-related needs surveys again.
As a staff member, you will be involved in 1 interview that is expected to take 30-45 minutes. During the interview, you will be asked about your typical resource provision and referral to supportive care services in your surgical unit.
The information gained will provide a baseline for when we implement changes to clinical care, allowing us to track any changes.
Implementation Phase
The aim of this study is to determine the effectiveness, feasibility and acceptability of the tailored resource and supportive care navigation tool.
You may be eligible for this study if you are a male or female age 18 or older in the surgical unit and diagnosed with pancreaticobiliary cancer or carer of the patient who meets this condition. You can also participate if you are a Hepatic Pancreatic and Biliary surgeon/nurse caring for patients diagnosed with pancreatobiliary cancer at Flinders Medical during the implementation phase of the project.
Study details
As a cancer survivor, you will be involved in 1 interview (30-45 minutes) to discuss your experiences of the new resource and navigation tool, complete a questionnaire about how acceptable you found the resource and navigation tool, and complete 2 cancer-related surveys (Supportive Care Needs Survey Short Form 34, Distress Thermometer) You will also participate in a phone conversation (approx.15 minutes), 6 and 12 months after enrolling in the study, during which you will repeat the 2 cancer-related surveys.
As a staff member, you will be involved in 4 interviews that are expected to take 30-45 minutes to discuss your experiences using the new resource and navigation tool including time spent, barriers and feedback.
In this project, we will hope to understand the use of the newly developed resource and navigation tool and the impact on people diagnosed with pancreatobiliary cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135806 0
A/Prof George Barreto
Address 135806 0
Flinders Medical Centre, Flinders Dr, Bedford Park South Australia, 5042
Country 135806 0
Australia
Phone 135806 0
+61 416151979
Fax 135806 0
Email 135806 0
[email protected]
Contact person for public queries
Name 135807 0
Dr Katia Ferrar
Address 135807 0
Flinders University, Sturt Rd, Bedford Park South Australia, 5042
Country 135807 0
Australia
Phone 135807 0
+61 8 7221 8471
Fax 135807 0
Email 135807 0
[email protected]
Contact person for scientific queries
Name 135808 0
Dr Katia Ferrar
Address 135808 0
Flinders University, Sturt Rd, Bedford Park South Australia, 5042
Country 135808 0
Australia
Phone 135808 0
+61 8 7221 8471
Fax 135808 0
Email 135808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.