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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
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Scientific title
Evaluate the effectiveness of implementing a supportive care navigation tool for people diagnosed with pancreatic cancer.
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Secondary ID [1]
312606
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer
334542
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unmet needs
334543
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survival
334544
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Condition category
Condition code
Cancer
331144
331144
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0
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Pancreatic
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Physical Medicine / Rehabilitation
331145
331145
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0
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Other physical medicine / rehabilitation
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Public Health
331146
331146
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329117
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Treatment: Other
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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.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Effectiveness outcome: Unmet needs
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Assessment method [1]
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Supportive Care Needs Survey Short Form 34
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Timepoint [1]
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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
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Primary outcome [2]
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Survival (reported as 1 year survival rate)
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Assessment method [2]
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Self-reported or proxy (carer)-reported status (phone call)
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Timepoint [2]
338895
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Control and Intervention Group: once 6 months and 12 months post study enrolment
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Primary outcome [3]
339172
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Effectiveness outcome: Distress
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Assessment method [3]
339172
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Distress Thermometer
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Timepoint [3]
339172
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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
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Secondary outcome [1]
437826
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acceptability (cancer survivors/carers)
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Assessment method [1]
437826
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Acceptability Questionnaire
Adapted from the generic intervention-specific acceptability questionnaire (Sekhon et al. 2022) based on the Theoretical Framework of Acceptability (TFA) (Sekhon et al. 2017)
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Timepoint [1]
437826
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once during 1-2 months post diagnosis
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Secondary outcome [2]
437827
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Feasibility outcome: uptake
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Assessment method [2]
437827
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
Log completed by surgeons/nurses detailing number of resources provided and use of navigation tool and participant reasons for decline of resource and use of navigation tool
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Timepoint [2]
437827
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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)
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Secondary outcome [3]
438880
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Satisfaction (and usefulness) with resource and navigation tool process (cancer survivor/carer)
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Assessment method [3]
438880
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Qualitative interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [3]
438880
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once 1-2 months post diagnosis
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Secondary outcome [4]
438881
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Perceived benefit (cancer survivor/carer)
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Assessment method [4]
438881
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Qualitative Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [4]
438881
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once 1-2 months post diagnosis
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Secondary outcome [5]
438882
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Barriers or issues with use (resource and navigation process) (cancer survivor/carer)
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Assessment method [5]
438882
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Qualitative Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [5]
438882
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Intervention group: once 1-2 months post diagnosis
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Secondary outcome [6]
438898
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Feasibility outcome: Time spent in service delivery (staff)
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Assessment method [6]
438898
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [6]
438898
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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
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Secondary outcome [7]
438899
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Feasibility outcome: Barriers to use and provision (staff)
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Assessment method [7]
438899
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [7]
438899
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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
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Secondary outcome [8]
438900
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Feasibility outcome: Satisfaction (staff)
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Assessment method [8]
438900
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [8]
438900
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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
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Secondary outcome [9]
438901
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Feasibility outcome: Recommendation for improvement (staff)
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Assessment method [9]
438901
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [9]
438901
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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
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Secondary outcome [10]
438902
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Feasibility outcome: Consistency and fidelity of use (staff)
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Assessment method [10]
438902
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [10]
438902
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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
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Secondary outcome [11]
438903
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Recommendation for improvement (cancer survivors/carers)
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Assessment method [11]
438903
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [11]
438903
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Intervention group: once 1-2 months post diagnosis
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Secondary outcome [12]
438909
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Typical supportive care practices (staff)
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Assessment method [12]
438909
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Control Group: Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [12]
438909
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once during control phase data collection period (6 month duration)
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Secondary outcome [13]
438910
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Typical supportive care resource and service use (cancer survivor/carer)
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Assessment method [13]
438910
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Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [13]
438910
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Control group: once 1-2 months post diagnosis
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Secondary outcome [14]
438911
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Barriers to supportive care access and use (cancer survivor/carer)
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Assessment method [14]
438911
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Control Group: Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [14]
438911
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Control Group: once 1-2 months post diagnosis
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Secondary outcome [15]
438912
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Experience of supportive care in surgical unit (cancer survivor/carer)
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Assessment method [15]
438912
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Control Group: Interview (semi-structured, one-on-one, either in person, phone or online depending on participant preference) with a member of the research team
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Timepoint [15]
438912
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Control Group: once 1-2 months post diagnosis
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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.
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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
Nil
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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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.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
23/09/2024
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Actual
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Date of last participant enrolment
Anticipated
24/11/2025
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Actual
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Date of last data collection
Anticipated
23/11/2026
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Actual
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Sample size
Target
95
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
26848
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
42910
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
317035
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Charities/Societies/Foundations
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Name [1]
317035
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Flinders Foundation
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Address [1]
317035
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Country [1]
317035
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Australia
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Primary sponsor type
Hospital
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Name
Flinders Medical Centre
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Address
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Country
Australia
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Secondary sponsor category [1]
319282
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University
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Name [1]
319282
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Flinders University
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Address [1]
319282
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Country [1]
319282
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315792
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
315792
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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
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Ethics committee country [1]
315792
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Australia
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Date submitted for ethics approval [1]
315792
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16/04/2024
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Approval date [1]
315792
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12/07/2024
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Ethics approval number [1]
315792
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76.24
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof George Barreto
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Address
135806
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Flinders Medical Centre, Flinders Dr, Bedford Park South Australia, 5042
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Country
135806
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Australia
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Phone
135806
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+61 416151979
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Fax
135806
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Email
135806
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[email protected]
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Contact person for public queries
Name
135807
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Dr Katia Ferrar
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Address
135807
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Flinders University, Sturt Rd, Bedford Park South Australia, 5042
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Country
135807
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Australia
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Phone
135807
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+61 8 7221 8471
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Fax
135807
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Email
135807
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[email protected]
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Contact person for scientific queries
Name
135808
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Dr Katia Ferrar
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Address
135808
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Flinders University, Sturt Rd, Bedford Park South Australia, 5042
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Country
135808
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Australia
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Phone
135808
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+61 8 7221 8471
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Fax
135808
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Email
135808
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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)?
No
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No/undecided IPD sharing reason/comment
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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.
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