RecruitingACTRN12624001200572

Testing the impact of a innovative digital resource, ActionPlan, on familial cancer patient empowerment.

Empower study: Testing the impact of a innovative digital resource, ActionPlan, on familial cancer patient empowerment.


Sponsor

Peter MacCallum Cancer Centre

Enrollment

354 participants

Start Date

Apr 22, 2025

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Finding out you carry a mutation in the BRCA1, BRCA2, or PALB2 genes — which significantly raises the risk of breast, ovarian, and other cancers — can be a life-changing and overwhelming experience. Knowing what to do next, which screening or preventive options to pursue, and how to talk to family members about inherited risk can be incredibly difficult without the right support. This study is testing ActionPlan, an interactive website that provides personalised risk information and guidance for people who have just received this kind of genetic result. Participants will be randomly assigned to receive ActionPlan alone, ActionPlan plus a follow-up phone call, or standard care. Changes in empowerment, decision-making confidence, and coping will be measured over 8 months. You may be eligible if you are 18 or older, have recently tested positive for a pathogenic BRCA1, BRCA2, or PALB2 variant, have no current or previous cancer diagnosis (breast, ovarian, or prostate), can read and understand English, and can provide informed consent. This study could transform how genetic counselling and support is delivered in the era of digital health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

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


Locations(1)

ACT,NSW,QLD,TAS,WA,VIC, Australia

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ACTRN12624001200572