None listed
Conditions
Brief summary
The primary purpose of this trial is to assess the impact of the Navigate online decision aid (DA) on the uptake of active surveillance as a management option for low risk prostate cancer patients. This can be achieved by assessing the impact of the online DA on decision making, confusion and distress, and decisional regret and by increasing the understanding of treatment options and side-effects for patients recently diagnosed with low risk prostate cancer (LRPC). Who is it for? You may be eligible to enrol in this trial if you are aged 18 years or over, and have been diagnosed with low risk prostate cancer within the last three months. Participants can be recruited Australia wide through an online self-referral or clinician-referral process (refer to website below). Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive access to the Navigate DA, or to receive links to the Prostate Cancer Foundation of Australia (PCFA) website, an existing information website for men with prostate cancer. Participants' partners will also have access to the allocated information resource. Participants and their partners will then be followed up at 1, 3 and 6 months to assess updake of active surveillance as the first line management option, preparedness for decision making, decisional conflict, regret, satisfaction, relationship outcomes and quality of life using questionnaires. It is hoped that this trial will provide information on the impact of the Navigate DA on the uptake of active surveillance, reducing confusion and distress associated with decision making regarding LRPC diagnosis.
Interventions
The Navigate Website: an Internet-based treatment DA for men diagnosed with localised prostate cancer. The goal of the Navigate DA is to reduce confusion, distress and decisional regret, and increase understanding of treatment options and side-effects. Patients and partners allocated to the intervention will be given access to the Navigate DA website.
The website has been developed using co-design methodology, meaning that consumers (users and potential users) were involved with every step of t
The Navigate Website: an Internet-based treatment DA for men diagnosed with localised prostate cancer. The goal of the Navigate DA is to reduce confusion, distress and decisional regret, and increase understanding of treatment options and side-effects. Patients and partners allocated to the intervention will be given access to the Navigate DA website. The website has been developed using co-design methodology, meaning that consumers (users and potential users) were involved with every step of the design phase. Content was based on the latest empirical evidence and iteratively reviewed by clinicians and consumers to ensure accuracy, relevance and completeness. The website contains seven main sections: 1. Prostate Cancer Information 2. Prostate Cancer Treatment Information and, Treatment Side Effects and management 3. DA & Values Clarification Exercise 4. Wellness Section 5. Gay Section 6. Partner Section 7. Video Section (contains 45 short films of consumer experiences and clinician information) Participants will have access to the online DA for 12 months (duration of their participation in the study) and will be able to access the website to use the DA as much or as little as they choose during this time.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible to participate in this trial if they are aged 18 years or over, have been diagnosed with LPC in the last three months, have been deemed eligible for AS by their treating clinician or meet the NCCN guidelines for AS*, have access to the Internet and have sufficient proficiency in English to complete study requirements and use the intervention website *NCCN Guidelines: AS Guidelines for Clinicians: PSA of 20 ng/mL or less clinical stage T1–2 Gleason score 6 In some circumstances men with the following clinical characteristics may also be offered AS: PSA of 10 ng/mL or less clinical stage T1–2a Gleason score = (3 plus 4 equals 7) when pattern 4 component accounts for less than 10% after pathological review. Partners are eligible to participate in this trial if they are aged 18 or over, are the designated partner (identified by patient) of an eligible patient (see above) who has consented to take part in the trial, have access to the internet and have sufficient proficiency in English to complete study requirements and use the intervention website
Exclusion criteria
Patients are ineligible if they currently have a severe psychiatric or cognitive disorder and/or are too unwell to participate as deemed by their treating doctor, or by self-report, or by the research team at consent Partners are ineligible if they are not able to provide informed consent as determined by the research team
Outcome results
None listed