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Trial registered on ANZCTR


Registration number
ACTRN12616001665426
Ethics application status
Approved
Date submitted
11/10/2016
Date registered
2/12/2016
Date last updated
21/10/2019
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 290302 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
NAVIGATE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 300547 0
Condition category
Condition code
Cancer 300406 300406 0 0
Prostate
Public Health 300407 300407 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296107 0
Treatment: Other
Intervention code [2] 296108 0
Behaviour
Comparator / control treatment
Participants randomised to the Control group will receive links to the Prostate Cancer Foundation of Australia (PCFA) website. This website is one of the leading health information resources for men diagnosed with prostate cancer in Australia. It has informational content relating to all components included within Navigate, however in less detail, and without videos, graphs or formal low health literacy copy editing. It is currently the best website for those diagnosed with prostate cancer to seek information regarding their diagnosis and treatment. It is therefore an appropriate alternative to be provided to those randomised into the usual care group.
Control group
Active

Outcomes
Primary outcome [1] 299851 0
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 be determined based on treating clinician report and confirmed via medical record audit, as well as MBS and PBS data.
Timepoint [1] 299851 0
Follow-up 1 will occurr at 1 month (4 weeks) after their consent date
Secondary outcome [1] 328318 0
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
Timepoint [1] 328318 0
Follow-up 1 at 1 month (4 weeks) after their consent date
Secondary outcome [2] 329566 0
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)
Timepoint [2] 329566 0
Follow-up 1 at 1 month (4 weeks) after their consent date
Secondary outcome [3] 329567 0
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
Timepoint [3] 329567 0
follow-ups 2 and 3 at 3 and 6 months after initial consent respectively
Secondary outcome [4] 329568 0
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
Timepoint [4] 329568 0
follow-ups 2 and 3 at 3 and 6 months after initial consent respectively
Secondary outcome [5] 329569 0
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
Timepoint [5] 329569 0
Baseline at time of cosent and Follow up 1 (4 weeks) after their consent date
Secondary outcome [6] 329570 0
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.
Timepoint [6] 329570 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study will use a two-armed, parallel-design, individually randomised trial with standard quantitative outcomes plus two embedded sub-studies (economic and web-analytics). This RCT will utilise processes based on the MRC framework.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Demographic, clinical, patient-reported outcome measures and partners’ data will be then imported into R version 3.3.0 (or higher) for analysis and graphing. The R package ggplot2 will be used to prepare any graphs. Prior to formal analysis, descriptive statistics and graphical displays will be used to identify missing and out-of-range values, assess distributional assumptions and identify outliers.

Recruitment bias will be assessed by comparing demographic and clinical characteristics of consenters and non-consenters using t-tests (or Mann-Whitney) and chi-squared (or Fisher’s exact) tests as appropriate.Differential attrition will be assessed by comparing baseline characteristics of drop-outs and continuing participants using t-tests (or Mann-Whitney) and chi-squared (or Fisher’s exact) tests as appropriate.

Outcome analysis. Study participants will be analysed as part of the study arm to which they were randomised in all outcome analysis. Pearson’s chi squared test will be used to analyse study arm differences in the primary outcome, uptake of AS as first-line management option for LPC. Analysis of covariance will be used to analyse study arm differences in the following secondary outcomes: preparedness for decision-making (follow-up 1 adjusted for baseline) and illness communication (follow-up 1 adjusted for baseline). Independent-samples t-tests will be used to analyse study arm differences in the following secondary outcomes: decisional conflict (follow-up 1), satisfaction (follow-up 2 and 3) and regret (follow-up 2 and 3). Finally, prostate cancer-specific quality of life will be analysed with a repeated measures model; more specifically, a reference cell model with the mean of the control group at baseline used as the reference An unstructured covariance type will be used to guard against misspecification and the model will be estimated by maximum likelihood.

Exploratory analysis. Study participants will be analysed as part of the study arm to which they were randomised in all exploratory analyses. Analysis of covariance will be used to analyse study arm differences in the following exploratory outcomes: men’s anxiety (follow-up 1 adjusted for baseline) and partners’ illness communication with men (follow-up 1 adjusted for baseline). Independent-samples t-tests will be used to analyse study arm differences in the following secondary outcomes: partners’ decisional conflict (follow-up 1), satisfaction (follow-up 2 and 3) and regret (follow-up 2 and 3).

As appropriate, effect size estimates for between-group differences will be calculated using recommended procedures. After inspection of the data, the suitability of stated methods will be assessed and revised as necessary.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 6793 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 6796 0
The Alfred - Prahran
Recruitment hospital [3] 6797 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 6799 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [5] 6800 0
Western Hospital - Footscray
Recruitment postcode(s) [1] 14451 0
3000 - Melbourne
Recruitment postcode(s) [2] 14453 0
3004 - Prahran
Recruitment postcode(s) [3] 14454 0
3084 - Heidelberg
Recruitment postcode(s) [4] 14456 0
3144 - Malvern
Recruitment postcode(s) [5] 14457 0
5022 - Henley Beach

Funding & Sponsors
Funding source category [1] 294682 0
Government body
Name [1] 294682 0
National Health and Medical Research Council
Address [1] 294682 0
GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601
Country [1] 294682 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John St, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 293530 0
None
Name [1] 293530 0
Address [1] 293530 0
Country [1] 293530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296108 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 296108 0
305 Grattan Street Parkville VIC 3000
Ethics committee country [1] 296108 0
Australia
Date submitted for ethics approval [1] 296108 0
12/09/2016
Approval date [1] 296108 0
07/10/2016
Ethics approval number [1] 296108 0
HREC/16/PMCC/114

Summary
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.
Trial website
https://www.navigateprostate.com.au
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 69586 0
Prof Penelope Schofield
Address 69586 0
Swinburne University of Technology
School of Health Sciences
Faculty of Health, Arts and Design
PO Box 218, HAWTHORN, VIC 3122
Internal Mail H24
(CRICOS Provider 00111D)
Country 69586 0
Australia
Phone 69586 0
+61 3 9214 4886
Fax 69586 0
Email 69586 0
pschofield@swin.edu.au
Contact person for public queries
Name 69587 0
Ms Natalie Richards
Address 69587 0
Peter MacCallum Cancer Centre
Department Cancer Experiences Research
305 Grattan Street Parkville
Vic 3000
Country 69587 0
Australia
Phone 69587 0
+61385597453
Fax 69587 0
Email 69587 0
navigate@petermac.org
Contact person for scientific queries
Name 69588 0
Ms Natalie Richards
Address 69588 0
Peter MacCallum Cancer Centre
Department Cancer Experiences Research
305 Grattan Street Parkville
VIC 3000
Country 69588 0
Australia
Phone 69588 0
+61 3 8559 7453
Fax 69588 0
Email 69588 0
navigate@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results