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Trial registered on ANZCTR


Registration number
ACTRN12624001200572p
Ethics application status
Submitted, not yet approved
Date submitted
9/09/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the impact of a innovative digital resource, ActionPlan, on familial cancer patient empowerment.
Scientific title
Empower study: Testing the impact of a innovative digital resource, ActionPlan, on familial cancer patient empowerment.
Secondary ID [1] 312741 0
The Empower study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
living with a BRCA2 pathogenic variant 334775 0
Breast cancer risk 335175 0
Ovarian cancer risk 335176 0
cancer worry 335177 0
living with a BRCA1 pathogenic variant 335263 0
Living with a PALB2 pathogenic variant 335264 0
Condition category
Condition code
Human Genetics and Inherited Disorders 331332 331332 0 0
Other human genetics and inherited disorders
Cancer 331666 331666 0 0
Breast
Cancer 331667 331667 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hybrid two effectiveness and Implementation trial
Arm 1. Access for 8 months to Comprehensive informational management website with decision tools called ActionPlan through login provided by email. Access is at participant discretion. ActionPlan contains personalised risk graphics based on age and risk reduction strategy undertaken, and information modules -breast cancer risk reduction /screening, ovarian cancer risk reduction, lifestyle factors, psychological support, grief support, reproductive options, family communication and cascade tool, rarer cancers and research opportunities. Use of Actionplan is collected through google analytics .

Arm 2. Access to ActionPlan as above, and follow up 20 min behavioural change -targeted telephone conversation at one month after access to ActionPlan
Intervention code [1] 329263 0
Prevention
Intervention code [2] 329264 0
Lifestyle
Intervention code [3] 329265 0
Behaviour
Comparator / control treatment
Standard care as currently provided by each specialist familial cancer or clinical genetic service in terms of patient information sheets or letter, follow up phones or formal on-going clinical management.
Control group
Active

Outcomes
Primary outcome [1] 339091 0
Patient empowerment at 8 months after recruitment
Timepoint [1] 339091 0
Before access to ActionPlan (baseline)- , 2 and 8 months (Primary outcome) after access to ActionPlan i.e login details have been sent or baseline survey returned for control arm
Secondary outcome [1] 438525 0
Coping with a genetic diagnosis
Timepoint [1] 438525 0
Before access to ActionPlan (baseline)- , 2 and 8 months after access to ActionPlan i.e login details have been sent or baseline survey returned for control arm
Secondary outcome [2] 438526 0
Decisional conflict
Timepoint [2] 438526 0
2 and 8 months after access to ActionPlan i.e login details have been sent or baseline survey returned for control arm

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion in this trial if all the following criteria apply:
• Any individual who tests positive in a NATA-accredited molecular laboratory for a germline likely pathogenic (Class4) or pathogenic (class 5) variant in either BRCA1, BRCA2 or PALB2 genes during the period of the trial,
• No personal history of breast, ovary or prostate cancer.
• No current cancer diagnosis or treatment of any type.
• Aged 18 years or ove
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible for inclusion in this trial if any of the following criteria apply:
• Unable to provide informed consent.
• Do not speak or read English.
• Any individual testing positive for a Class 3 variant (genetic variant of uncertain clinical significance) as part of segregation testing
• Any Individual identified as having a germline BRCA1, BRCA2 or PALB2 Class 4 or Class 5 genetic variants prior to study commencement.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, randomisation of the first member of each family is undertaken centrally in the RedCap central study database
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation at family level using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
3 arm cluster randomized by family
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
354
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317172 0
Charities/Societies/Foundations
Name [1] 317172 0
National Breast cancer foundation
Country [1] 317172 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 319437 0
None
Name [1] 319437 0
Address [1] 319437 0
Country [1] 319437 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315917 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 315917 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 315917 0
Australia
Date submitted for ethics approval [1] 315917 0
12/08/2024
Approval date [1] 315917 0
Ethics approval number [1] 315917 0

Summary
Brief summary
Who is it for?
You may be eligible for this study if you are a male or female over the age of 18, and test positive in a NATA-accredited molecular laboratory for a germline likely pathogenic (Class 4) or pathogenic (class 5) variant in either BRCA1, BRCA2 or PALB2 genes during the period of the trial, and have no current cancer diagnosis of any type, or previous diagnosis of breast, ovary or prostate cancer.

Study details
In this Hybrid two effectiveness and Implementation trial, participants will be randomly allocated to 1) access to the Website - ActionPlan, 2) access to ActionPlan with telephone conversation one month after access to improve uptake of the website or 3) standard care. In the Website ActionPlan arm, participants will receive personalised interactive risk graphics, and information modules -breast cancer risk reduction /screening, ovarian cancer risk reduction, lifestyle factors, psychological support, grief support, reproductive options, family communication and cascade tool, rarer cancers and research opportunities. The website can be accessed at the participant discretion. In the ActionPlan and telephone conversation arm, participants will receive access to the website ActionPlan and a follow up telephone call one month after access to ActionPlan using behaviour change theory aimed at addressing any digital or health literacy issues.

Participants will be followed up at baseline, 2 , 5 and 8 months post intervention commencement to assess for patient empowerment, coping with a genetic diagnosis, and decisional conflict.
It is hoped that this study will contribute to our understanding of digital interventions in healthcare, and improve person-centred care by empowering participants to be more actively engaged in in their health and values- based decision making.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136210 0
A/Prof Alison Trainer
Address 136210 0
Peter MacCallum cancer centre, 305 Grattan st, Melbourne, Victoria, 3000
Country 136210 0
Australia
Phone 136210 0
+610385595322
Fax 136210 0
Email 136210 0
[email protected]
Contact person for public queries
Name 136211 0
Alison Trainer
Address 136211 0
Peter MacCallum cancer centre, 305 Grattan st, Melbourne, Victoria 3000
Country 136211 0
Australia
Phone 136211 0
+610385595322
Fax 136211 0
Email 136211 0
[email protected]
Contact person for scientific queries
Name 136212 0
Alison Trainer
Address 136212 0
Peter MacCallum cancer centre, 305 Grattan st, Melbourne, Victoria, 3000
Country 136212 0
Australia
Phone 136212 0
+610385595322
Fax 136212 0
Email 136212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participation data
When will data be available (start and end dates)?
From publication for 5 years
Available to whom?
researchers with sound proposal
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
by request to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24180Clinical study report  [email protected]



Results publications and other study-related documents

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

Documents added automatically
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