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Trial registered on ANZCTR


Registration number
ACTRN12620001035910
Ethics application status
Approved
Date submitted
18/07/2020
Date registered
12/10/2020
Date last updated
12/10/2020
Date data sharing statement initially provided
12/10/2020
Date results information initially provided
12/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using a video aid to support values conversations between patients and caregivers in advance care planning.
Scientific title
Video decision support tool promoting values conversations between cancer patients and caregivers to enable advanced care planning
Secondary ID [1] 301820 0
None
Universal Trial Number (UTN)
U1111-1255-6808
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 318296 0
Condition category
Condition code
Cancer 316307 316307 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Video vignettes will be developed from findings of our preliminary research into ACP in cancer patients and made into a 10-15 minute video. The video vignettes will depict scenarios of dyads communicating across three stages of a cancer trajectory, with each stage introducing considerations for the completion of different sections of an ACP (Medical Treatment Decision Maker, Statment of Values, Instructional Directives). A total of 6 vignettes will be created. Professional actors will be sourced from known professional college and university sources, and a pilot video will be created prior to the filming of the final videos. The video vignettes will be circulated to a multidisciplinary team for validation and approval and further editing before the final video intervention is created.
2. the sessions will be facilitated by a trained nurse and administered to patient-caregiver
dyads – a patient with a diagnosis of incurable cancer and a nominated caregiver. In this study, caregivers are defined as a relative, partner, or friend who has a significant relationship with the patient and who provides them with social, psychological, and/or physical assistance.
3. The total duration of the intervention will be for 45 minutes. Participants will receive two telephone call prompts at two-week intervals following the intervention as a reminder to return the completed documents.
4. The project team will meet monthly to review the progress of the study. Adherence to the research protocol will be monitored throughout the study through field notes and diaries managed by the researchers. Protocol violations or operational issues will be discussed and resolved at project team meetings. The study steering committee will monitor the study and provide ongoing oversight into early results. If necessary, modifications of the study will be made.
Intervention code [1] 318119 0
Behaviour
Comparator / control treatment
Patient-caregiver dyads will be provided with an explanation of advance care planning (ACP) and be provided with the hospital's ACP document, and verbal and the hospitals written guidelines on how to complete the document (https://www.cabrini.com.au/assets/Admission/advance-care-planning/ADVANCE-CARE-DIRECTIVE-INSTRUCTIONS-A4-pdf.pdf. ) Questions will be fielded, and finally, participants will be provided with the patient and caregiver post-questionnaires to be returned with the completed ACP in a stamped return envelope. Participants will receive two telephone call prompts at two-week intervals following the intervention as a reminder to return the completed documents.
Control group
Active

Outcomes
Primary outcome [1] 324481 0
The primary outcome measure will be the completion of advance care planning (ACP) documents provided to the participants. We will specifically examine completion of various sections of the ACP (Appointment of Medical Treatment Decision Maker and Support Person, Values and Instructional Directives)
Timepoint [1] 324481 0
at 2 weeks post-intervention / usual care with 2 follow up calls made at 2-week intervals if ACP documents are not returned
Secondary outcome [1] 384779 0
Patient understanding of advance care planning (ACP) opportunities, distress, and confidence related to ACP will be measured using the Pre-post ACP Intervention Questionnaire (PPAIQ), designed and tested in a previous feasibility study. It comprises 9 patient items, exploring understanding and perspectives on ACP and is measured on a 10 point Likert scale.
Timepoint [1] 384779 0
Patient PPAIQ is measured immediately pre-intervention and completed at a single time point post-intervention by patients. The questionnaire is expected at 2 weeks post-intervention / usual care with 2 follow up calls made at 2-week intervals if ACP documents are not returned
Secondary outcome [2] 385711 0
Congruence in decision-making will be measured using the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF). CCAT-PF consists of 18 items and measures congruence in patient-caregiver communication with the analogous patient (CCAT-P) and family (CCAT-F) instruments, exploring preferences, values, and experiences in treatment decision-making. The CCAT-PF demonstrated internal reliability coefficients for the CCAT-P (a = .52), CCAT-F (a = .50), and CCAT-PF (a = .60). Higher CCAT-PF scores are significantly correlated with greater patient depression and perceived family conflict, lower patient–caregiver assessment and well-being, and less expressiveness and family cohesion.
Timepoint [2] 385711 0
CCAT-PF is measured immediately pre-intervention and completed at a single time point post-intervention by patients and caregivers. Questionnaire are expected at 2 weeks post-intervention / usual care with 2 follow up calls made at 2-week intervals if ACP documents are not returned
Secondary outcome [3] 385712 0
Patient preparation for decision-making will be measured using the Preparation for decision-making scale, a validated scale assessing patient and caregiver perception of the usefulness of an intervention. Psychometric analysis has shown Alpha coefficients for internal consistency ranging from 0.92 to 0.96 and that the scale discriminated significantly between patients who did and did not find a decision aid helpful (p < 0.0001).
Timepoint [3] 385712 0
Patient preparation for decision-making is completed at a single time point post-intervention by patients. The questionnaire is expected at 2 weeks post-intervention / usual care with 2 follow up calls made at 2-week intervals if ACP documents and questionnaires are not returned
Secondary outcome [4] 386833 0
Caregiver understanding of advance care planning (ACP) opportunities, distress, and confidence related to ACP will be measured using the Pre-post ACP Intervention Questionnaire (PPAIQ), designed and tested in a previous feasibility study. It comprises 8 caregiver items, exploring understanding and perspectives on ACP and is measured on a 10 point Likert scale.
Timepoint [4] 386833 0
Caregiver PPAIQ is measured immediately pre-intervention and completed at a single time point post-intervention by caregivers. Questionnaire are expected at 2 weeks post-intervention / usual care with 2 follow up calls made at 2-week intervals if ACP documents are not returned
Secondary outcome [5] 386834 0
Caregiver preparation for decision-making will be measured using the Preparation for decision-making scale, a validated scale assessing patient and caregiver perception of the usefulness of an intervention. Psychometric analysis has shown Alpha coefficients for internal consistency ranging from 0.92 to 0.96 and that the scale discriminated significantly between patients who did and did not find a decision aid helpful (p < 0.0001).
Timepoint [5] 386834 0
Caregiver preparation for decision-making is completed at a single time point post-intervention by caregivers. The questionnaire is expected at 2 weeks post-intervention / usual care with 2 follow up calls made at 2-week intervals if ACP documents and questionnaires are not returned

Eligibility
Key inclusion criteria
Patients
• Patients with a diagnosis of cancer will be recruited from the oncology and palliative care services of Cabrini Health and the palliative care services of Calvary Bethlehem Hospital.
• Participants will be aged at least 18 years
• Sufficiently proficient in English to complete questionnaires
• Cognitively intact
• Not having previously completed all components of an ACP/AD
• Able to provide consent

Caregiver

• Caregiver of a patient participant
• Aged at least 18 years of age
• Sufficiently proficient in English to complete questionnaires
• Able to provide consent

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient
• Too unwell to participate in the study as determined by the patient’s treating physician
• Currently participating in more than 2 other studies in the hospital

Caregiver

• Known or demonstrated cognitive or psychological difficulties

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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Groups will be compared for baseline values and for mean changes in outcome measures between baseline and study completion. Logistic regression will be used for the rates of integration of ACP into the medical record. We will use linear regression adjusted for baseline values to evaluate group differences for the DCS and congruence CCAT-PF outcomes. Based on the primary outcome of the integration of ACP documentation into the medical record and assuming an integration rate of around 37% for the control group, with a total of 86 participants/dyads (43 per group) we would be able to show a significant improvement to 67% integration for the intervention group (power 80%, 5% significance level and two-sided testing). Assuming a mean change of 3.2 units in the DCS and a conservative estimate of the standard deviation at 7, with 86 participants we would have 80% power to detect an improvement to 7.5 units for the intervention group. This sample size would have similar power to detect a difference in the mean change for congruence scores of about 6 units.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17116 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [2] 17117 0
Cabrini Hospital - Prahran - Prahran East
Recruitment postcode(s) [1] 30792 0
3144 - Malvern
Recruitment postcode(s) [2] 30793 0
3181 - Prahran East

Funding & Sponsors
Funding source category [1] 306247 0
Charities/Societies/Foundations
Name [1] 306247 0
Cabrini Foundation
Address [1] 306247 0
Cabrini Foundation
181-183 Wattletree Road
Malvern VIC 3144
Country [1] 306247 0
Australia
Funding source category [2] 306248 0
Charities/Societies/Foundations
Name [2] 306248 0
Bethlehem Griffith Research Foundation
Address [2] 306248 0
29/120 Cambridge Street
Collingwood VIC 3066
Country [2] 306248 0
Australia
Primary sponsor type
Hospital
Name
Cabrini Foundation
Address
181-183 Wattletree Road
Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 306733 0
University
Name [1] 306733 0
University of Notre Dame
Address [1] 306733 0
160 Oxford St
Darlinghurst, NSW 2010
Country [1] 306733 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306457 0
Cabrini Human Research Ethics Committee.
Ethics committee address [1] 306457 0
181-183 Wattletree Road, Malvern, VIC 3144
Ethics committee country [1] 306457 0
Australia
Date submitted for ethics approval [1] 306457 0
19/01/2017
Approval date [1] 306457 0
27/03/2017
Ethics approval number [1] 306457 0
09-27-02-17

Summary
Brief summary
Many cancer patients and families strive to maintain hope in the face of adversity. Thus discussions on future care should be timed to follow adjustment to the diagnosis, recognise the capacity to integrate hope with truthful communication, and accommodate the preferences from those who hold diverse values and beliefs.
Our research program aims to promote a patient and family centred approach to ACP, respectful of individual patient preferences and values. We have previously described the iterative and dynamic nature of decision-making in cancer, the caregiver role in decision-making, the benefit of patient-caregiver dyads as an entity in ACP and introduced the
vignette technique as an approach to facilitate discussions.
More recently, innovative approaches such as the use of video decision support tools (VDST) have been used to elicit EOL care preferences. We aim to explore this novel way by modelling values-based EOL decision-making conversations between patient-caregiver dyads, to assist patients and their families to reach shared-decision making.
We were awarded a Bethlehem Research Griffith Foundation Grant in 2018. To date 87 patient-caregiver dyads have been randomized to an intervention or control arm. Our preliminary statistical analysis suggest that we have to expand our sample size to ensure more meaningful outcomes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103950 0
A/Prof Natasha Michael
Address 103950 0
Cabrini Palliative and Supportive Care Department
646 High Street Prahran 3181 Melbourne VIC
Country 103950 0
Australia
Phone 103950 0
+61 3 95085027
Fax 103950 0
Email 103950 0
nmichael@cabrini.com.au
Contact person for public queries
Name 103951 0
A/Prof Natasha Michael
Address 103951 0
646 High Street Prahran 3181 Melbourne VIC
Cabrini Palliative and Supportive Care Department
Country 103951 0
Australia
Phone 103951 0
+61 3 95085027
Fax 103951 0
Email 103951 0
nmichael@cabrini.com.au
Contact person for scientific queries
Name 103952 0
A/Prof Natasha Michael
Address 103952 0
646 High Street Prahran 3181 Melbourne VIC
Cabrini Palliative and Supportive Care Department
Country 103952 0
Australia
Phone 103952 0
+61 3 95085027
Fax 103952 0
Email 103952 0
nmichael@cabrini.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
consent not sought
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary