Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000359831
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
30/03/2021
Date last updated
8/11/2021
Date data sharing statement initially provided
30/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The PRoCESS Trial: Pancreatic cancer Relatives Counselling and Education Support Service trial.
Scientific title
PRoCESS: Pancreatic cancer Relatives Counselling and Education Support Service trial. Assessing the effect of nurse-led counselling, on participant-reported outcomes and use of medical services.
Secondary ID [1] 303319 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PRoCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 320548 0
Anxiety 320549 0
Depression 320550 0
Fatigue 320951 0
Condition category
Condition code
Cancer 318404 318404 0 0
Pancreatic
Mental Health 318405 318405 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 318406 318406 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PRoCESS is a pragmatic trial of a nurse-led telehealth counselling service for family carers of people diagnosed with pancreatic cancer. The study design is a two-arm randomised controlled trial in which 200 people who are caring for patients with pancreatic cancer will be randomised in a 1:1 ratio to: A four-month structured telephone counselling intervention plus a comprehensive information package supplied by PanKind, The Australian Pancreatic Cancer Foundation (Arm 1); or the information package alone (Arm 2).

The study duration for each participant will be 6 months of follow-up.

Participants in Arm 1 will be offered ten one-hour counselling sessions over four months (weekly for 4 weeks, then fortnightly) and then if desired further monthly booster sessions until 30/04/2023 i.e. the end of the study. The mode of delivery will be by video conferencing (zoom, skype or equivalent) or telephone, based on participant preference. With consent, all sessions will be recorded.

The intervention is based on a self-efficacy paradigm and involves assessing needs, delivering intervention components appropriate to those needs, revaluating needs at each session, and providing a care plan or referrals where the nurse’s assessment is that further management may be warranted. The intervention will be delivered by a trained palliative care or oncology nurse and will cover the following components (as required):
1. Psychoeducation about the psychological impact of cancer
2. Coping, problem-solving and stress management skills
3. Cognitive therapy and challenging unhelpful thoughts
4. Enhancing relationships and support networks
5. Psychoeducation about non-pharmacological approaches for stress management (mindfulness, exercise, relaxation)
6. Education about pharmacotherapy for patients’ pain
7. Education about management of pancreatic exocrine insufficiency
8. Psychoeducation about managing complex medication regimens and their side-effects
9. Psychoeducation about decline in mobility and/or functional status
10. End-of-life decision-making, care planning, strategies to enhance hope
11. Bereavement counselling

Intervention implementation will be evaluated using the RE-AIM Framework.
In terms of intervention fidelity our study database will track completed session as per the planned schedule over four months/enrolled intervention participants.
Intervention code [1] 319624 0
Treatment: Other
Intervention code [2] 319625 0
Behaviour
Comparator / control treatment
Our partner organisation, PanKind, has developed a pancreatic cancer information package that will be provided to carers in hard-copy and online as their 'attention control treatment'. It contains modules on treating pancreatic cancer, questions for doctors, symptoms, perspectives of patients, caring for someone, hope when cancer won’t go away, finding information on the web.

Participants in both the intervention (Arm 1) and attention control (Arm 2) groups will receive this in addition to standard care which includes involvement in consultations with oncologist and social workers seeing the patient. as well as access to support services provided by not-for-profit organisations including Cancer Councils, Carers Australia and PanSupport.
Control group
Active

Outcomes
Primary outcome [1] 326387 0
Carers anxiety assessed by the HADS-A mean score
Timepoint [1] 326387 0
Time points: Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [1] 391274 0
Carers self-efficacy assessed by a composite of the mean scores of the four separate domains on the Caregiver Inventory: Managing Medical Information; Caring for Care Recipient; Caring for Oneself; and Managing Difficult Interactions/Emotions,
Timepoint [1] 391274 0
Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [2] 391275 0
Carers depression assessed by the HADS-D mean score
Timepoint [2] 391275 0
Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [3] 391276 0
Carers fatigue assessed as the mean score on a 10 point Visual Analogue Scale (VAS) with instructions and response format the same as an item from the Brief Fatigue Inventory.
Timepoint [3] 391276 0
Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [4] 391277 0
Carers psychological and emotional unmet needs assessed as a domain score of the SCNS-P&C
Timepoint [4] 391277 0
Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [5] 392416 0
Carers quality of life assessed as the mean score of the CarerQol-7D
Timepoint [5] 392416 0
Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [6] 392417 0
Carers quality-adjusted life years assessed as mean weighted sum cost-utility score from the CarerQol-7D
Timepoint [6] 392417 0
Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [7] 392418 0
Patients number of emergency department presentations assessed by:
1) Monthly data collection telephone calls to carers for 6 months after recruitment to ascertain patients’ emergency department presentations,
2) Linkage to the Queensland Hospital Admitted Patient Data Collection. Note participants not treated in Queensland hospitals and who do not consent to this will be excluded from this component.
Timepoint [7] 392418 0
End of Trial
Secondary outcome [8] 392419 0
Number of days patients spent in hospital assessed by:
1) Monthly data collection telephone calls to carers for 6 months after recruitment to ascertain number of days patients spent in hospital.
2) Linkage to the Queensland Hospital Admitted Patient Data Collection. Note participants not treated in Queensland hospitals and who do not consent to this will be excluded from this component.
Timepoint [8] 392419 0
End of Trial
Secondary outcome [9] 392420 0
Number of days after patients diagnosis to palliative care referral assessed by:
1) Asking carers in their baseline questionnaire "Has the person who you care for been referred to or seen a palliative care doctor or nurse? (if yes specify referral date and date first seen)"
2) Monthly data collection telephone calls to carers for 6 months after recruitment to ascertain if/when patient has been referred to palliative care.
Timepoint [9] 392420 0
End of Trial
Secondary outcome [10] 392421 0
Patients overall survival time post diagnosis (all-cause mortality) as reported by the carer in monthly data collection telephone calls and verified (where possible) with linkage to Qld Hospital Admitted Patient Data Collection.
Timepoint [10] 392421 0
End of Trial
Secondary outcome [11] 392422 0
Patients quality-adjusted life years as assessed by mean weighted survival time using EuroQoL-5D (EQ-5D-5L)
Timepoint [11] 392422 0
Baseline (at enrollment), and follow-up assessments at 2, 4 and 6 months after baseline.
Secondary outcome [12] 392423 0
Cost-effectiveness of the intervention assessed by Incremental cost-per QALY ratios assessed by carer monthly telephone interview data and linked health services (MBS) or medications (PBS) data and EuroQoL-5D.
Timepoint [12] 392423 0
End of Trial
Secondary outcome [13] 392424 0
Participation rate (%) assessed by comparing participants and eligible non-participants in terms of demographics and patient clinical characteristics.
Timepoint [13] 392424 0
End of Trial
Secondary outcome [14] 392425 0
Intervention fidelity (completed sessions/enrolled participants).
Timepoint [14] 392425 0
End of Trial

Eligibility
Key inclusion criteria
* Primary carer for a patient who was diagnosed with pancreatic cancer within the last 3 months
* Resident in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Inability to read and speak English
* Intention to complete fewer than 6 counselling sessions

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A statistician external to the study team will generate the randomisation allocation list. Randomisation will be implemented within REDCap; no study staff or investigators will be able to view the randomisation allocation list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following baseline assessment, carers will be randomised using computer-generated permuted-block randomisation. Randomisation will be stratified by sex, age (less than 65 vs greater than or equal to 65 years), residence (capital city or not) and whether or not their patients’ tumour has been or is planned to be resected. A separate random allocation sequence will be generated for each stratum, and automatically applied to the next eligible carer by our database.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determination:
Effect size estimates for our research questions take into account clinically meaningful differences and are based on our formative work. For our primary research question we have calculated the sample size required to detect a mean difference of 2 in the anxiety score between the intervention and control groups. Detecting these differences with 90% power and 5% significance (two-tailed) requires 91 participants per group for anxiety (assuming a standard deviation of 4.8). Conservatively estimating 5% will later be deemed ineligible after medical records release and 5% attrition rate (i.e. those with data at baseline only) we require 100 participants per group for our primary research question. This sample size provides between 70% and 90% power to detect clinically relevant intervention effects for our secondary outcomes.
Statistical analyses:
The primary analyses will be based on intention-to-treat principles. All outcome variables using participant-reported outcomes will be defined on a continuous scale, with analyses occurring separately for carers and patients. We will use linear mixed model to assess the effects of the intervention, accounting for repeated outcome scores over time, controlling for time and any important time-varying covariates such as patients’ vital status. Interaction between the group the carer is randomised to and time will also be investigated to determine if the effect of the intervention varies with time. In subgroup analyses, we will determine whether the effect estimates differ according to whether the carer has a patient who is participating in the study. We anticipate that confounding will be minimal due to the randomisation. However, any baseline variables that differ between the trial arms and are associated with the outcome will be included as co-variates.
Overall survival: We will use Cox survival models to determine differences in the time to death between the patients with carers in the intervention versus the attention control group, with appropriate adjustments and secondary analyses as described above.
Cost-effectiveness: We will compare the costs and health benefits of the intervention and control groups from a health system perspective. Data will be captured for resources including those for intervention delivery, caregiver time and health service use by patients and carers. Emergency department and unplanned hospitalisations will be assessed. The health benefits will be assessed separately for carer and patient quality-adjusted life years (QALYs). Generalised estimating equations will assess both time and treatment effects and allow for non-parametric and missing data on health utilities. Using the area-under-the-curve method and health utility scores at each time point, a single QALY for each caregiver and patient will be calculated at the last time point. Incremental cost-per QALY ratios will be generated. One-way and probabilistic sensitivity analyses to address data uncertainty will be performed using TreeAge Pro for Healthcare (TreeAge Software Inc). We will consider a Markov microsimulation model informed by our clinical data. Methods for this economic evaluation will be governed by best practice guidelines and have been used extensively by CI Gordon.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/04/2021
Actual
23/08/2021
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
200
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 18529 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 18530 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 18531 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 18532 0
The Wesley Hospital - Auchenflower
Recruitment hospital [5] 18533 0
Nambour General Hospital - Nambour
Recruitment hospital [6] 18534 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 18535 0
Holy Spirit Northside - Chermside
Recruitment hospital [8] 18536 0
The Townsville Hospital - Douglas
Recruitment hospital [9] 18537 0
Pindara Private Hospital - Benowa
Recruitment hospital [10] 18538 0
Cairns Base Hospital - Cairns
Recruitment hospital [11] 18539 0
The Prince Charles Hospital - Chermside
Recruitment hospital [12] 18540 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment hospital [13] 18541 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [14] 18542 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [15] 18543 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [16] 18544 0
Allamanda Private Hospital - Southport
Recruitment hospital [17] 18545 0
Mater Hospital Pimlico - Pimlico
Recruitment hospital [18] 18546 0
Caboolture Hospital - Caboolture
Recruitment hospital [19] 18547 0
Ipswich Hospital - Ipswich
Recruitment hospital [20] 18548 0
Logan Hospital - Meadowbrook
Recruitment hospital [21] 18549 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [22] 18550 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [23] 18551 0
St Vincent's Hospital - Toowoomba
Recruitment hospital [24] 18552 0
Mackay Base Hospital - Mackay
Recruitment hospital [25] 18553 0
Mater Private Hospital - South Brisbane
Recruitment hospital [26] 18554 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 32903 0
4029 - Herston
Recruitment postcode(s) [2] 32904 0
4120 - Greenslopes
Recruitment postcode(s) [3] 32905 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 32906 0
4066 - Auchenflower
Recruitment postcode(s) [5] 32907 0
4560 - Nambour
Recruitment postcode(s) [6] 32908 0
4215 - Southport
Recruitment postcode(s) [7] 32909 0
4032 - Chermside
Recruitment postcode(s) [8] 32910 0
4814 - Douglas
Recruitment postcode(s) [9] 32911 0
4217 - Benowa
Recruitment postcode(s) [10] 32912 0
4870 - Cairns
Recruitment postcode(s) [11] 32913 0
4224 - Tugun
Recruitment postcode(s) [12] 32914 0
4350 - Toowoomba
Recruitment postcode(s) [13] 32915 0
4020 - Redcliffe
Recruitment postcode(s) [14] 32916 0
4101 - South Brisbane
Recruitment postcode(s) [15] 32917 0
4810 - Pimlico
Recruitment postcode(s) [16] 32918 0
4510 - Caboolture
Recruitment postcode(s) [17] 32919 0
4305 - Ipswich
Recruitment postcode(s) [18] 32920 0
4131 - Meadowbrook
Recruitment postcode(s) [19] 32921 0
4700 - Rockhampton
Recruitment postcode(s) [20] 32922 0
4670 - Bundaberg
Recruitment postcode(s) [21] 32923 0
4740 - Mackay
Recruitment postcode(s) [22] 32924 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 307735 0
Government body
Name [1] 307735 0
National Health and Medical Research Council
Country [1] 307735 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston Road
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 308436 0
None
Name [1] 308436 0
Address [1] 308436 0
Country [1] 308436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307762 0
Queensland Health Royal Brisbane and Women's Hospital HREC(EC00172)
Ethics committee address [1] 307762 0
Ethics committee country [1] 307762 0
Australia
Date submitted for ethics approval [1] 307762 0
23/10/2020
Approval date [1] 307762 0
29/01/2021
Ethics approval number [1] 307762 0
HREC/2021/QRBW/67567

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108402 0
A/Prof Vanessa Beesley
Address 108402 0
Senior Research Officer
QIMR Berghofer Medical Research Institute
Locked Bag 2000
Royal Brisbane Hospital,
Herston QLD 4029
Country 108402 0
Australia
Phone 108402 0
+61 7 3362 0272
Fax 108402 0
+61 7 3845 3502
Email 108402 0
vanessa.beesley@qimrberghofer.edu.au
Contact person for public queries
Name 108403 0
Vanessa Beesley
Address 108403 0
Senior Research Officer
QIMR Berghofer Medical Research Institute
Locked Bag 2000
Royal Brisbane Hospital,
Herston QLD 4029
Country 108403 0
Australia
Phone 108403 0
+61 7 3362 0272
Fax 108403 0
+61 7 3845 3502
Email 108403 0
vanessa.beesley@qimrberghofer.edu.au
Contact person for scientific queries
Name 108404 0
Vanessa Beesley
Address 108404 0
Senior Research Officer
QIMR Berghofer Medical Research Institute
Locked Bag 2000
Royal Brisbane Hospital,
Herston QLD 4029
Country 108404 0
Australia
Phone 108404 0
+61 7 3362 0272
Fax 108404 0
+61 7 3845 3502
Email 108404 0
vanessa.beesley@qimrberghofer.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participants are able to tick a box indicating that they “agree to share my de-identified data for future research”. By ticking this box participants are agreeing to sharing all their de-identified study data to future projects with ethical approval for use of this data.
When will data be available (start and end dates)?
This data will be available upon collection which is anticipated to start 06/04/2021, with a minimum retention period of 5 years from the last date of publication, or 15 years for clinical data.
Available to whom?
Future projects with ethical approval.
Available for what types of analyses?
It is difficult to tell what future projects may want to use this data. Possibilities may include consortium analyses or sub-study analyses. These would only be to achieve aims in the proposals approved by the research team.
How or where can data be obtained?
Contact the principal investigator Associate Professor Vanessa Beesley on Vanessa.Beesley@qimrberghofer.edu.au or 07 3362 0270.


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.