avigate: Randomised controlled trial of an online treatment decision aid for men with localised prostate cancer and their partners

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Cancer - Prostate; Public Health - Health promotion/education

• Registration Number: ACTRN12616001665426
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-02
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is uptake of Active Surveillance as the first-line management option for localised prostate cancer assessed as a dichotomous outcome (AS or curative treatment option) at follow-up 1. This will based on participant's self-report at follow-up 1.[Follow-up 1 will occurr at 1 month (4 weeks) after their consent date]