None listed
Conditions
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.
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. 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, reprodu
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
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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.
Outcome results
None listed