This is a NHMRC funded trial ‘Navigate’ to evaluate the impact of an online resource for men with low-risk prostate cancer when making a treatment decision, and to assess the uptake of Active Surveillance; satisfaction with treatment decision, decisional conflict and regret.
Our research found that men with early stage, low-risk prostate cancer face more difficulties with treatment decision-making than any other cancer clinical group. This is especially true when treatment choices are comparable in terms of survival outcomes but the side effect profiles differ markedly.
Men need to be well informed and understand all of their management options. Our research team co-designed an online information and decision-support tool to facilitate men’s and their partners’ understanding of treatment options, associated benefits and risks and to ensure treatment choices are concordant with their values.
This resource presents up-to-date, unbiased information tailored to Australian men in multiple formats: written, graphical and video, that lead the man and their partner through a values clarification exercise, which is the process of weighing up the benefits and costs in terms of their own values, of whether to adopt Active Surveillance or curative treatment: radical prostatectomy, brachytherapy or external beam radiotherapy.
Incorporating the assessment of lifestyle factors into the treatment decision-making process reflects the complexities of decision-making in real clinical practice. Included are over 40 videos of men, partners, oncologists, urologists and specialist prostate nurses to provide a range of perspectives and personal experiences. The website also includes a section for partners and gay men.
The research study is run nationally to test the resource through a randomised controlled trial.
Recruitment is open until 31 October 2020.
To evaluate the impact of an online Decision Aid (DA) for men with low-risk prostate cancer and their partners on:
- Uptake of Active Surveillance as first-line management option
- Men’s preparedness for decision-making
- Men’s decisional conflict, regret and satisfaction
- The quality of men’s communication with their partners’ about their illness
- Men’s prostate cancer-specific quality of life.
- Men diagnosed with early stage, low-risk prostate cancer within the last 3 months
- Who are still deciding on their treatment options
- One treatment option includes Active Surveillance (i.e. close monitoring)
- Lives in Australia
- Aged over 18 years
- Has access to the internet
- Able to read and write in English.
Clinic Referral - Participating sites with ethics approval screen and recruit patients through their urology outpatient clinics.
Clinician Referral – The treating clinician refers their patient directly to the trial or provides the Navigate website details so the patient can register themselves.
* Partners of men are also invited to participate.
Participating sites with ethics approval include the following public and private hospitals:
Peter MacCallum Cancer Centre (Coordinating Centre), Cabrini Health | Australian Urology Associates, Austin Health, Alfred Health and Western Health.
WHAT PARTICIPATION INVOLVES
Participants are randomised to one of two prostate cancer websites (intervention and control) to read the information and consider their options. They will be asked to complete four online questionnaires over a six-month period. Communication with participants is over the phone and email so recruitment and follow-up is convenient and accessible for men (and their partners) from anywhere in Australia.
Swinburne University of Technology
National Health and Medical Research Council (NHMRC)
Professor Penelope Schofield
Professor of Health Psychology, Swinburne University of Technology.
Head of Behavioural Science, Peter MacCallum Cancer Centre.
Phone: +61 3 9214 4886
Email: [email protected]