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Trial registered on ANZCTR


Registration number
ACTRN12620000170921
Ethics application status
Approved
Date submitted
3/02/2020
Date registered
17/02/2020
Date last updated
2/07/2021
Date data sharing statement initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Why do men leave active surveillance? A case-control study examining factors contributing to non-adherence
Scientific title
A case-control study examining social-ecological factors contributing to non-adherence in active surveillance for prostate cancer.
Secondary ID [1] 300320 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 315925 0
Condition category
Condition code
Cancer 314198 314198 0 0
Prostate
Public Health 314548 314548 0 0
Epidemiology
Mental Health 314549 314549 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a case-control observational study. Cases will consist of prostate cancer patients who transitioned from active surveillance to active treatment without evidence of disease progression. They will be identified through the South Australian Prostate Cancer Clinic Outcomes Collaborative (SA-PCCOC) and the Prostate Cancer Outcomes Collaborative in Victoria (PCOR-VIC).
All participants will complete a one-time survey (sent via mail but may be completed on paper, online, or via telephone), which takes approximately 20 minutes to complete. This survey consists of research team developed questions and validated measures and aims to explore the social-ecological factors (i.e., personal, social, community, organisation, policy) which may influence men's experiences on active surveillance and their decision to transition to treatment (particularly for when disease progression has not yet occurred). A priming letter and reminder letter will be sent 1-2 weeks prior to and after the study materials are sent. To participate, participants must provide consent for their information stored on the registry to be accessed and complete the survey. A consent form and study information will be provided with the survey, along with a reply-paid envelope.
Intervention code [1] 316599 0
Not applicable
Comparator / control treatment
Cases and controls will undergo the same procedure. Matched controls will comprise of patients on active surveillance at the time of data extraction or men who have transitioned to treatment (with disease progression). These will be sourced from the SA-PCCOC and PCOR-VIC. Cases/Controls will be matched on date of diagnosis and length of time on active surveillance. All participants will complete the same survey (however those still on active surveillance will not complete one section pertaining to reasons for transitioning to treatment) and must consent to their registry information being accessed and matched with their survey information.
Control group
Active

Outcomes
Primary outcome [1] 322625 0
Identify the social-ecological variables associated with non-adherence to active surveillance (i.e., transitioning to active treatment without evidence of disease progression). Questions relating to this aim were comprised of researcher-written questions (based on peer-reviewed relevant literature) and validated measures. This is a composite outcome. Validated measures used are:
1. Supportive Care Needs Survey (short-form)
2. Perceived Autonomy Support - Healthcare Climate Questionnaire (short form)
3. Memorial Anxiety Scale for Prostate Cancer
4. Patient Health Questionnaire (short-form)
5. BRIEF-COPE
6. Enriched Social Support Inventory
7. Godin Leisure-time exercise questionnaire.
Timepoint [1] 322625 0
Measured in one-time survey.
Secondary outcome [1] 379089 0
Explore men's reasons for non-adherence to active surveillance. Questions relating to this aim were written by the research team and based on peer-reviewed literature.
Timepoint [1] 379089 0
Measured in one-time survey.

Eligibility
Key inclusion criteria
Eligible men will be identified by the prostate cancer registries involved in the study; The South Australian Prostate Cancer Clinical Outcomes Collaborative (SA-PCCOC) and the Victorian Division of the Prostate Cancer Outcomes Registry (PCOR-VIC). The men must meet the following criteria:

- Diagnosed with prostate cancer from 2014 - 2019
- Aged 75 or younger at diagnosis
- The patient is alive and previously consented to registry data collection/questionnaire receiving
- Commenced active surveillance after diagnosis (i.e., chosen treatment)
- May have transitioned to active treatment after a period of active surveillance (no treatment within 10 months of diagnosis)

Note: Disease progression is considered to have occurred if:
- Follow-up biopsy shows Gleason of 7 or more, OR
- Follow-up biopsy has 2 or more positive cores, OR
- PSA has doubled within 3 years.

Note: Active surveillance is operationalised as:
- A coding of active surveillance as the treatment type on the registry
- A period of time after diagnosis of low-intermediate risk prostate cancer (see D'Amico Risk Classifications) in which the patient did not receive active treatment, but rather received at least 1 follow-up PSA test/DRE/biopsy
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men will be excluded from participating if they are unable to complete a survey written in English

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis
Cox proportional hazards model will be constructed stratifying by matched sets and including social-ecological factors (primarily individual and interpersonal). To assess which factors are associated with non-adherence, separate logistic regressions will be constructed where each factor is an outcome (note; demographic factors will be included as covariates).
To assess the prevalence of the primary reasons for non-clinical transitions, in men who transitioned for non-clinical reasons only, the prevalence and covariance of the primary reasons will be assessed. To assess associations between demographic factors and the most common reasons for non-clinical transitions, the Cox models described above will be repeated with the event of interest being restricted to transitions associated of each particular primary reason.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2020
Actual
20/02/2020
Date of last participant enrolment
Anticipated
29/05/2020
Actual
29/05/2020
Date of last data collection
Anticipated
31/07/2020
Actual
29/05/2020
Sample size
Target
250
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 304745 0
Charities/Societies/Foundations
Name [1] 304745 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Country [1] 304745 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace, Adelaide, 5005, South Australia, Australia
Country
Australia
Secondary sponsor category [1] 305314 0
None
Name [1] 305314 0
Address [1] 305314 0
Country [1] 305314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305165 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 305165 0
Ethics committee country [1] 305165 0
Australia
Date submitted for ethics approval [1] 305165 0
Approval date [1] 305165 0
04/06/2019
Ethics approval number [1] 305165 0
HREC/19/SAC/88

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99458 0
Dr Camille Short
Address 99458 0
Room 812, Redmond Barry Building, Parkville

The University of Melbourne, Victoria 3010 Australia
Country 99458 0
Australia
Phone 99458 0
+61 3 8344 1192
Fax 99458 0
Email 99458 0
camille.short@unimelb.edu.au
Contact person for public queries
Name 99459 0
Megan McIntosh
Address 99459 0
SAHMRI
North Terrace,
Adelaide, South Australia
5005
Country 99459 0
Australia
Phone 99459 0
+61 8 8128 4738
Fax 99459 0
Email 99459 0
megan.mcintosh@adelaide.edu.au
Contact person for scientific queries
Name 99460 0
Megan McIntosh
Address 99460 0
SAHMRI
North Terrace,
Adelaide, South Australia
5005
Country 99460 0
Australia
Phone 99460 0
+61 8 8128 4738
Fax 99460 0
Email 99460 0
megan.mcintosh@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected from the study will be shared.
When will data be available (start and end dates)?
As soon as possible following publication. There is no current end-date.
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Data will be published unrestricted on Figshare (https://figshare.com/).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.