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

• Register: ANZCTR
• Last refreshed on: 22 February 2021
• Main ID: ACTRN12616001665426
• Date of registration: 02/12/2016
• Prospective Registration: Yes
• Primary sponsor: Swinburne University of Technology
• Public title: Navigate: Randomised controlled trial of an online treatment decision aid for men with localised prostate cancer and their partners
• Scientific title: Navigate: Randomised controlled trial of an online treatment decision aid for men with localised prostate cancer and their partners
• Date of first enrolment: 30/05/2017
• Target sample size: 304
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616001665426.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Natalie Richards

• Name: Ms Natalie Richards

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Prostate

Public Health - Health promotion/education

Prostate Cancer;
Prostate Cancer

Intervention(s)

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.

Primary Outcome(s)

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]

Secondary Outcome(s)

Quality of patients’ and partners’ illness communication.
The quality of men’s illness communication with their partners will be assessed at baseline and follow-up 1 with the 4-item Couples Illness Communication Scale (CICS). The CICS was adapted for use in prostate cancer populations. The original scale has shown acceptable internal consistency (Cronbach’s a= 0.80) and convergent validity with other measures of dyadic adjustment[Baseline at time of cosent and Follow up 1 (4 weeks) after their consent date]

Decisional conflict.
Men’s decisional conflict will be assessed at follow-up 1 with the 16-item Decisional Conflict Scale (DCS). The DCS total scale is suitable for use with cancer patients and has shown acceptable internal consistency (Cronbach’s a=0.78-0.92), test-retest reliability (r=0.81) and responsiveness (longitudinal validity)[Follow-up 1 at 1 month (4 weeks) after their consent date]

Decisional regret.
Men’s decisional regret will be assessed with the 5-item Decisional Regret Scale (DRS). The DRS has shown acceptable internal consistency (Cronbach's a =0.81-0.92) and convergent validity with related measures (r =0.31-0.60) and responsiveness[follow-ups 2 and 3 at 3 and 6 months after initial consent respectively]

Decisional satisfaction.
Men’s decisional satisfaction will be assessed at follow-ups 2 and 3 with the 6-item Satisfaction with Decision (SWD) measure. The SWD has shown acceptable internal consistency (Cronbach's a=0.86), discriminant validity and responsiveness[follow-ups 2 and 3 at 3 and 6 months after initial consent respectively]

Preparedness for decision-making.
Men’s preparedness for decision-making will be assessed at baseline and follow-up 1 with the preparedness for decision-making scale. The PrepDM total scale was designed specifically to assess decision-aids used in a health context and has shown acceptable internal consistency (Chronbach’s a=0.92 to 0.96), and Item Response Theory analyses demonstrated that all ten scale items function very well[Follow-up 1 at 1 month (4 weeks) after their consent date]

Prostate cancer-specific quality of life.
Prostate cancer-specific quality of life will be assessed at baseline with the 26-item Expanded Prostate Cancer Index Composite short-form (EPIC-26). The EPIC-26 comprises four subscales: urinary, bowel, sexual and
hormonal summaries. The hormonal subscale is not relevant to this group as hormones are not usually prescribed to those diagnosed with LRPC, and therefore will not be included. All four subscales have shown acceptable internal consistency (all Cronbach’s a >0.70), test-retest reliability (all r>0.69) and responsiveness when used independently, therefore using only three of the four scales will not impact on the reliability and validity of the measure.[Baseline at time of cosent
Follow-up 1 Follow-up 1 at 1 month (4 weeks) after their consent date
FOllow up 2 3 months after initial consent
Follow-up 3 6 months after initial consent ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

National Health and Medical Research Council

Ethics review

Status: Approved
Approval date: 07/10/2016
Contact:

Peter MacCallum Cancer Centre