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Trial registered on ANZCTR


Registration number
ACTRN12617000174381
Ethics application status
Approved
Date submitted
20/01/2017
Date registered
2/02/2017
Date last updated
23/11/2021
Date data sharing statement initially provided
23/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
TrueNTH solutions: an integrated multi-component intervention to improve the lives of men with prostate cancer in Australia
Scientific title
TrueNTH solutions: an integrated multi-component intervention to improve the lives of men with prostate cancer in Australia
Secondary ID [1] 290735 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TrueNTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 301314 0
Condition category
Condition code
Cancer 301069 301069 0 0
Prostate
Public Health 301121 301121 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men with prostate cancer and their partner/carer will receive a 12 month individualised intervention.

1. Care coordination
Local service providers and the central care coordination service where necessary, will work collaboratively to implement coordination interventions. These include screening, assessment, navigation, information and education, ongoing monitoring, and practical and social support. Consented men will receive an initial consultation with a Care Coordinator, face-to-face or via videoconferencing or telephone, to assess their symptoms and health needs and provide tailored information and education. The duration of the initial consultation varies according to the man's stage of disease and health needs. The mode of the consultation will depend on local service availability, access and preferences of the man. The Care Coordinator will then communicate with the man's care providers (i.e. specialist medical doctors, nurses, allied health practitioners and general practitioner) to develop a care plan for the man, which contains referrals to other relevant prostate cancer services. The man will also be provided with access to a webpage that can be accessed via a computer or a mobile device. On this webpage, he will be able to enter symptoms related to recovery from prostate cancer that he may be experiencing. This will allow the Care Coordinator and other health professionals involved in his care to closely monitor his recovery from the effects of prostate cancer and provide ongoing advice and support over 12 months. If men do not have access to a computer or mobile device, hard copies of the care plan and/or other information will be provided, as required. The Care Coordinator and other health professionals involved in the care can provide ongoing assessment, monitoring and support face-to-face or via a telephone.

Based on assessment of needs and preferences, the Care Coordinator may also refer the man to relevant support services to address practical needs relating to transport, accommodation, finance, legal, employment, partners/carers support and advance care planning as required. The coordination service will also provide information to the man and his carer about a range of peer support programs.

2. Decision support
Men who have been newly diagnosed with localized prostate cancer will have access to an online decision support aid, the Personal Patient Profile Prostate (P3P), which will support the man in understanding the treatment options and adverse effects against his own values and thus reduce the burden of making the decision and later decision regret, and improve informed consent. P3P is developed and evaluated in the US and has been modified to suit the Australian context (language/text, definitions, statistics, videos and web links).

3. Lifestyle management
An appropriate, prescribed, evidence-based exercise program developed by TrueNTH researchers at Edith Cowan University (ECU) will be provided to men with prostate cancer regardless of their stage of disease; past, current or future treatments; financial capacity; or geographic location. Where possible, the exercise prescription once developed will be implemented in face-to-face consultations; or by telephone or videoconference with a local accredited exercise physiologist (AEP) identified by the TrueNTH team. The exercise prescriptions will be tailored to the individual to address the specific issues causing men's greatest concern, to prepare them for future treatments such as surgery, or to address post-treatment issues. The exercises performed and the number, frequency and duration of exercise sessions will thus be determined on an individual basis. Regular monitoring of the man will ensure safety as well as providing motivation to continue to adhere to the exercise prescription.

In addition, all men will undergo an initial nutrition screening with the TrueNTH service at point of entry. The initial consult with the TrueNTH Dietitian will assess the need for referral to a local Accredited Practicing Dietitian (APD), or continue servicing the man through teleconferencing or video conferencing. Referral will be made to a local APD for a comprehensive nutritional assessment where possible depending on the capacity of the local health service and the preference of the man. The duration of the initial nutrition consultation with the dietitian varies according to the man's stage of disease and nutritional needs.

4. Specialized clinical support services
The care coordinator will work with the man's treating team to match services to the need and preference of the man and his partner/carer at entry and at any point during the intervention. The navigation will involve referral to the following specialist services where required, using specified study protocols:

* Psychological support and management
The care coordinator will undertake the screening using the 'distress thermometer' and identify factors associated with any distress. For men and/or partners/carers with moderate or high level needs at referral or at any follow up assessment, referral will be made to local or central psychological support and management services.

* Sexual recovery
The intervention aims to provide a range of sexual rehabilitation interventions tailored to the needs of the individual/couple and stratified according to needs and risk factors. This intervention will commence pre-treatment where possible. At the initial care coordinator consultation, all men will receive standard information and education relating to sexual recovery issues. Assessment and ongoing monitoring will identify men with sexual recovery needs who require additional services. Where required these men will be referred to a relationship and intimacy counsellor with expertise in prostate cancer locally, and if not available locally will be referred to the Monash Health or Royal Women's Hospital intimacy and relationship counselling service (Victoria); and/or erectile dysfunction management supported by Men's Erectile Solutions (Queensland).

* Continence management
At the initial care coordinator consultation, all men will receive standard information and education relating to continence issues. Assessment and ongoing monitoring will identify men with continence needs who require additional services. These men will be referred to local continence advisors where available and/or referred to the Continence Foundation Australia (CFA) if such services are not available. CFA will liaise with the treating specialist team to contribute to development of a continence plan through advice and expertise.

5. Prostate cancer comorbidities management
At entry to the intervention, the care coordinator will liaise with the man's GP to facilitate the assessments for metabolic risk assessment (for men with advanced prostate cancer) or for comorbidities (for men with localised prostate cancer). Based on this assessment the GP can liaise with the treating team to facilitate management of any identified risks and conditions.

6. Partner/carer support
The care coordinator will also provide partner/carer support as appropriate, including information provision and referral to local or central counselling services as required. Partners/carers are encouraged to attend appointments with the man. If the partner/carer is identified as needing care, a care plan will be developed. The referral and follow up processes for the partner/carer will be similar to the man.

Not all men will need to access all of the TrueNTH intervention components. The man will only be referred to the components needed, as identified during screening and assessment, and agreed by the treating specialist/team.
Intervention code [1] 296640 0
Treatment: Other
Intervention code [2] 296641 0
Rehabilitation
Intervention code [3] 296642 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300530 0
Prostate health symptoms as assessed using The Expanded Prostate Cancer Index short form (EPIC-26)
Timepoint [1] 300530 0
At baseline, and at up to 3 time points during the intervention and 12 months after intervention commencement
Primary outcome [2] 300815 0
Patient psychological distress as assessed using Distress Thermometer and the General Health Questionnaire (GHQ-12)
Timepoint [2] 300815 0
At baseline, and at up to 3 time points during the intervention and 12 months after intervention commencement
Primary outcome [3] 300816 0
Patient experiences of care as assessed using the Picker Patient Experience Questionnaire (PPE-15) and the National Cancer Control Indicators-Patient Experience Indicator (NCCI-PEx 1-8).
Timepoint [3] 300816 0
At baseline, and at up to 3 time points during the intervention and 12 months after intervention commencement
Secondary outcome [1] 330237 0
Patient health status as assessed using EQ-5D-5L
Timepoint [1] 330237 0
At baseline, and at up to 3 time points during the intervention and 12 months after intervention commencement
Secondary outcome [2] 330242 0
Patient health behaviour as assessed using the Godin Leisure-time Exercise Questionnaire
Timepoint [2] 330242 0
At baseline, and at up to 3 time points during the intervention and 12 months after intervention commencement
Secondary outcome [3] 330243 0
Partner/Carer health status as assessed using EQ-5D-5L
Timepoint [3] 330243 0
At baseline, and at up to 3 time points during the intervention and 12 months after intervention commencement
Secondary outcome [4] 330244 0
Patient and Partner/Carer health service usage as assessed using the Resource Utilisation Questionnaire
Timepoint [4] 330244 0
At baseline and 12 months after intervention commencement
Secondary outcome [5] 330245 0
Patient and Partner/Carer health service usage and cost, using their Medicare and Pharmaceutical Benefits Scheme data obtained from the Department of Human Services
Timepoint [5] 330245 0
Prior to the study and 12 months after intervention commencement
Secondary outcome [6] 330246 0
Contextual factors influencing implementation of the intervention, as assessed by interviews with patients, partners/carers, staff involved in the intervention delivery
Timepoint [6] 330246 0
For patients and partners/carers, at 6 months after intervention commencement;
For staff, at the end of study.
Secondary outcome [7] 331065 0
Partner/Carer psychological distress as assessed using Distress Thermometer and GHQ-12
Timepoint [7] 331065 0
At baseline, and at up to 3 time points during the intervention and 12 months after intervention commencement

Eligibility
Key inclusion criteria
Men will be eligible for the study if they have been diagnosed with prostate cancer and are receiving services from any of the participating sites. His partner/carer must be aged 18+ years; competent to give informed consent; and able to complete questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men will be excluded from the study if they are:
* too unwell (as determined by treating clinician); and/or
* have difficulties in adequately understanding written or verbal information in English; and/or
* have physical, psychological or cognitive difficulties that would prevent them from participating in the study or completing self-reported outcome measures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study involves a multiple case study design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2017
Actual
18/04/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
28/08/2018
Date of last data collection
Anticipated
30/09/2019
Actual
30/09/2019
Sample size
Target
1052
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
NT,QLD,SA,VIC
Recruitment hospital [1] 7162 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 7163 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [3] 8318 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [4] 8319 0
Tennant Creek Hospital - Tennant Creek
Recruitment hospital [5] 8320 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 9573 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [7] 9574 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 14920 0
3084 - Heidelberg
Recruitment postcode(s) [2] 14921 0
3220 - Geelong
Recruitment postcode(s) [3] 16382 0
0870 - Alice Springs
Recruitment postcode(s) [4] 16383 0
0860 - Tennant Creek
Recruitment postcode(s) [5] 16384 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 18327 0
0810 - Tiwi
Recruitment postcode(s) [7] 18328 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 295194 0
Charities/Societies/Foundations
Name [1] 295194 0
The Movember Foundation
Country [1] 295194 0
Australia
Funding source category [2] 295195 0
Charities/Societies/Foundations
Name [2] 295195 0
Beyondblue
Country [2] 295195 0
Australia
Primary sponsor type
Individual
Name
Professor Patsy Yates
Address
Faculty of Health
Queensland University of Technology
O Block, D Wing, Level 7
Kelvin Grove
Queensland 4059
Country
Australia
Secondary sponsor category [1] 294024 0
Individual
Name [1] 294024 0
Professor Rob Carter
Address [1] 294024 0
Deakin Health Economics
Deakin University
Building BC, 221 Burwood Highway
Burwood
Victoria 3125
Country [1] 294024 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296546 0
Austin Health Human Research Ethics Committee (Lead HREC)
Ethics committee address [1] 296546 0
Ethics committee country [1] 296546 0
Australia
Date submitted for ethics approval [1] 296546 0
25/10/2016
Approval date [1] 296546 0
02/12/2016
Ethics approval number [1] 296546 0
HREC/16/Austin/436
Ethics committee name [2] 296728 0
QUT Human Research Ethics Committee (Administrative Review)
Ethics committee address [2] 296728 0
Ethics committee country [2] 296728 0
Australia
Date submitted for ethics approval [2] 296728 0
06/12/2016
Approval date [2] 296728 0
23/12/2016
Ethics approval number [2] 296728 0
1600001160
Ethics committee name [3] 297917 0
Central Australian Human Research Ethics Committee
Ethics committee address [3] 297917 0
Ethics committee country [3] 297917 0
Australia
Date submitted for ethics approval [3] 297917 0
Approval date [3] 297917 0
22/03/2017
Ethics approval number [3] 297917 0
CA-17-2785
Ethics committee name [4] 297918 0
Tasmanian Human Research Ethics Committee
Ethics committee address [4] 297918 0
Ethics committee country [4] 297918 0
Australia
Date submitted for ethics approval [4] 297918 0
Approval date [4] 297918 0
24/05/2017
Ethics approval number [4] 297918 0
H0016423
Ethics committee name [5] 299244 0
Northern Territory Department of Health and Menzies School of Health Research HREC
Ethics committee address [5] 299244 0
Ethics committee country [5] 299244 0
Australia
Date submitted for ethics approval [5] 299244 0
Approval date [5] 299244 0
03/08/2017
Ethics approval number [5] 299244 0
HREC-2017-2769

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

Contacts
Principal investigator
Name 71122 0
Prof Patsy Yates
Address 71122 0
Faculty of Health
Queensland University of Technology
O Block, D Wing, Level 7, Kelvin Grove, Queensland 4059
Country 71122 0
Australia
Phone 71122 0
+61 7 31385780
Fax 71122 0
Email 71122 0
[email protected]
Contact person for public queries
Name 71123 0
Patsy Yates
Address 71123 0
Faculty of Health
Queensland University of Technology
O Block, D Wing, Level 7, Kelvin Grove, Queensland 4059
Country 71123 0
Australia
Phone 71123 0
+61 7 31385780
Fax 71123 0
Email 71123 0
[email protected]
Contact person for scientific queries
Name 71124 0
Patsy Yates
Address 71124 0
Faculty of Health
Queensland University of Technology
O Block, D Wing, Level 7, Kelvin Grove, Queensland 4059
Country 71124 0
Australia
Phone 71124 0
+61 7 31385780
Fax 71124 0
Email 71124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified survey data
When will data be available (start and end dates)?
Beginning 3 months following main results publication and ending 15 years following completion of the study (2034).
Available to whom?
Only researchers who seek permission from the Principal Investigator at QUT.
Available for what types of analyses?
Only to achieve the aims in the QUT approved proposal.
How or where can data be obtained?
Access subject to approvals by the Principal Investigator at QUT (Professor Patsy Yates: [email protected])


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
SourceTitleYear of PublicationDOI
EmbaseEvaluating a multicomponent survivorship programme for men with prostate cancer in Australia: A single cohort study.2022https://dx.doi.org/10.1136/bmjopen-2021-049802
N.B. These documents automatically identified may not have been verified by the study sponsor.