ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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

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]

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

Breast cancer risk

Ovarian cancer risk

cancer worry

living with a BRCA1 pathogenic variant

Living with a PALB2 pathogenic variant

Condition category

Condition code

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Cancer

Breast

Cancer

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Patient empowerment at 8 months after recruitment

Timepoint [1]

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]

Coping with a genetic diagnosis

Timepoint [1]

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]

Decisional conflict

Timepoint [2]

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?

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]

Charities/Societies/Foundations

Name [1]

National Breast cancer foundation

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Peter MacCallum Cancer Centre

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Peter MacCallum Cancer Centre Human Research Ethics Committee

Ethics committee address [1]

https://www.petermac.org/research/doing-research-us/ethics-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/08/2024

Approval date [1]

Ethics approval number [1]

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

A/Prof Alison Trainer

Address

Peter MacCallum cancer centre, 305 Grattan st, Melbourne, Victoria, 3000

Country

Australia

Phone

+610385595322

Fax

Alison.Trainer@Petermac.org

Contact person for public queries

Name

Alison Trainer

Address

Peter MacCallum cancer centre, 305 Grattan st, Melbourne, Victoria 3000

Country

Australia

Phone

+610385595322

Fax

Alison.Trainer@Petermac.org

Contact person for scientific queries

Name

Alison Trainer

Address

Peter MacCallum cancer centre, 305 Grattan st, Melbourne, Victoria, 3000

Country

Australia

Phone

+610385595322

Fax

Alison.Trainer@Petermac.org

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 Alison.Trainer@petermac.org

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24180	Clinical study report			Alison.Trainer@petermac.org

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically