ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000499583

Ethics application status

Approved

Date submitted

30/04/2015

Date registered

19/05/2015

Date last updated

21/01/2022

Date data sharing statement initially provided

21/01/2022

Date results information initially provided

21/01/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

A pilot study to assess the feasibility of an integrated survivorship intervention to improve patient and service level outcomes for men with prostate cancer. ‘The True NTH Pilot Study’

Scientific title

A pilot study to assess the feasibility of an integrated survivorship intervention to improve patient and service level outcomes for men with prostate cancer. ‘The True NTH Pilot Study’

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate cancer

Condition category

Condition code

Cancer

Prostate

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Care Coordination
A locally based care coordinator and the central care coordination service will work collaboratively to implement the coordination interventions, including screening and assessment, navigation and ongoing monitoring. Men who meet the inclusion criteria will be identified by the treating team, who will refer the man to the True NTH coordinator as early as possible in the care pathway. Following referral to the True NTH service by the treating team, the local care coordinator will undertake a comprehensive screening and assessment process in a structured face to face consultation. This initial screening and assessment is communicated to the treating team and provides the basis for development of a care plan and referral to other relevant True NTH services. All men will then be provided with a technology supported platform which enables them to undertake ongoing self-monitoring of symptoms and needs on a 3 monthly basis, or when new symptoms emerge. An alert will be sent to the True NTH care coordinator and general practitioner when assessments are completed. On the basis of these assessments, navigation to the following services will occur: a)Central Coordination Service; b)Practical support; c)Lifestyle Plan; and d) Peer group.

Not all men will need to access all of the True NTH 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.

2. Information Provision and Decision Support
At the time of recruitment, the care coordinator will make available to the man and their carer the appropriate education and decision support material relevant to their stage of disease and treatment. The education package will include evidence based patient education booklets according to need. The local care coordinator will provide a one-to-one instructional session with the patient and carer, tailoring information to patient and carer needs. The local care coordinator will also provide self management messages to reinforce key messages for preventing and responding to physical or psychological symptoms, drawing on evidence based information included in the information and education packages.

The local care coordinator will introduce men with localised prostate cancer to an online decision support aid - the Personal Patient Profile - Prostate (P3P) Decision Support Aid1, which will be modified to suit the Australian context (language/text, definitions, statistics, videos and weblinks). The treating team will access the information gained from the patient’s use of the decision support aid to facilitate discussion regarding treatment choices.

3. Practical Support
The local care coordinator and central True NTH services will refer the man to relevant support services to address practical needs relating to transport, accommodation, finance and advance care planning. These referrals will be based on assessment of needs and preferences. Local service registries will be developed to support referral, with reference to True NTH Specialist Services where local services are unavailable to meet the man’s needs.

4. Peer Support
The local care coordinator and central coordination service will provide information to the man and his carer about a range of peer support programs. The list of local services will be developed following the initial mapping of local peer support initiatives and advice from Prostate Cancer Foundation Australia and Cancer Council contacts.

5. Lifestyle Plan
1) Exercise
An appropriately prescribed, evidence-based exercise prescription developed by researchers at Edith Cowan University (ECU) will be provided to men regardless of their stage of disease, past, current or future treatments, financial capacity or geographic location. The program will be delivered through multiple modes, depending on available resources, including: a)Face-to-face consultations with an accredited exercise physiologist (AEP); b)Telephone or online teleconference with an AEP; c)Online delivery via a web site with customisation to the individual’s requirements and contraindications; d)DVD exercise programs with generic prescriptions for men at different stages of disease and treatment; e)Paper based exercise programs with generic prescriptions for men at different stages of disease and treatment. For an exercise clinic staffed by AEPs, laboratory standard tests will be applied. The AEP will provide initial face to face assessment, develop a tailored exercise prescription and support the man remotely as required over time to maintain adherence to the program, adjusting as needed. Where no EP is available, telehealth assessment and ongoing support will be provided, drawing on the support of other allied health, medical and nursing professionals where appropriate.

The exercise assessment and prescription will be provided from Edith Cowan University (ECU). The exercise prescriptions will be tailored to the individual to address the specific issues causing greatest concern or to prepare them for future treatments such as surgery, or to address post-treatment issues. That is, the exercise physiologist will deliver a structured program relevant to the man’s disease stage. The program will include the following components: a)The man undergoing a curative treatment option prostatectomy or radiation oncology will undertake a 6-8 week exercise program in readiness for treatment incorporating a pelvic floor exercise program; b)All other men will have an exercise program tailored for them individually by an exercise physiologist following the Exercise and Sports Science Australia (ESAA) guideline for cancer; c)Men with advanced prostate cancer will have a specialised exercise program focused on impact exercise for those receiving ADT or with bone metastasis. Regular monitoring of the man will ensure safety as well as providing motivation to continue to adhere to the exercise prescription. To facilitate this, the latest technology for biometric monitoring will be used to track key fitness and health measures. This will be coordinated through ECU using their online data collection systems.

2) Nutrition
True NTH will provide access to services of a dietician either locally or through central coordination services, depending on the capacity of the local health service and preferences of the man. The man will undergo an initial nutrition screening using the Malnutrition Screening Tool and calculating body mass index (BMI). In addition to the initial screening for malnutrition and excess weight at referral to the True NTH local care coordinator, additional screening points will include: a)At completion of curative treatment or those on active surveillance; b)At diagnosis of advanced prostate cancer and then at 3 monthly intervals. If identified to be at risk at any screening point, men are referred to an Accredited Practicing Dietitian (APD) for a comprehensive nutritional assessment. This referral will be to a local APD where available, or to a central care coordinator who will facilitate referral to an APD if no local service is available.

6. Specialised Support Services
The local care coordinator will work with the local treating teams to match services to the needs and preferences of the man and their carer at entry to the True NTH program and at any point during the study intervention phase. The navigation will involve referral to the following specialist services where required:
1)Psychological services
The local care coordinator will undertake the initial screening using the ‘distress thermometer’ and identify factors associated with any distress. Men with mild or moderate anxiety and/or depression will be referred to an online self management program. The self-management program focuses on developing skills to manage distress and is delivered by Mindspot. For men with moderate or high level needs at referral or at any follow up assessment, referral will be made to: a)Psychological support services within the treating service where available; b)Remote psychological support services coordinated by the central coordination service, and delivered by staff from Peter MacCallum Cancer Centre.

2)Sexual health
At referral to the local care coordinator, all men will receive standard information and education relating to sexual health issues. Assessment and ongoing monitoring will identify men with sexual health needs who require additional services. These men will be referred to a local sexual health counsellor where available or referred to a specialist service from the centralised True NTH service where local services are not available.

3)Continence services
At referral to the local care coordinator, 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 a continence plan through advice and expertise.

7. Advance Prostate Cancer Comorbidities management
On enrolment to the study, the local care coordinator will liaise with the patient’s GP to facilitate the following assessments: a)For men with localised prostate cancer an assessment for comorbidities, using RACGP Guidelines; b)For men with advanced prostate cancer, a specific set of tests and measures for osteoporosis, cardiovascular disease, obesity and diabetes.
Based on this assessment the GP will be provided with care plan guidelines to facilitate management of any identified risks and conditions. The lifestyle component of the True NTH intervention will also support the man to minimise risk of ADT adverse effects as well as those from other treatments for men with advanced prostate cancer.

While each component of the intervention is available for all men, the intervention and each of its components are tailored to the patient’s stage of disease and their health related needs. Delivery of specialised support services will depend on resource availabililty, access, treating specialist /team preference and preference of the man. The service model incorporates centralised coordination and referral to specilist services where required, as it is acknowledged that all services may not be available at a local region. The total duration of the intervention is 6 months.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Intervention code [3]

Lifestyle

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of delivering each of the intervention components, as assessed using on-line survey and qualitative interviews with patients, carers, care coordinators, treating team members and other health professionals involved in providing True NTH services. The on-line survey was designed specifically for this study.

Timepoint [1]

At 6 months after intervention commencement

Primary outcome [2]

Fidelity of intervention delivery, as assessed using 1)qualitative data from transcripts of baseline care coordinator consultation sessions and quantitative data from the checklists completed by care coordinators; 2)care coordinator questionnaire after the completion of each contact with a participant (the questionnaire was designed specifically for this study); 3)the first 5 baseline care coordinator consultation sessions will be tape recorded and transcribed verbatim for analysis; and 4)periodically check on compliance with study protocols as part of regular meetings between the principal researchers, care coordinators and research assistants.

Timepoint [2]

Throughout the 6 month intervention period

Primary outcome [3]

Safety of intervention components, will be assessed through rigorous reporting of adverse events.

Timepoint [3]

Throughout the 6 month intervention period

Secondary outcome [1]

Patient quality of life as assessed using Functional Assessment of Cancer Therapy scale, EQ-5D-5L and Assessment of Quality of Life Multi-Attribute Utility Instrument

Timepoint [1]

Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [2]

Prostate cancer symptoms as assessed using The Expanded Prostate Cancer Index Composite

Timepoint [2]

Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [3]

Patient decision conflict and decision regret as assessed using Decisional Conflict Scale or Decisional Regret Scale

Timepoint [3]

Baseline, and/or at 3 and 6 months after intervention commencement

Secondary outcome [4]

Patient psychological distress as assessed using General Health Questionnaire-12

Timepoint [4]

Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [5]

Patient supportive care needs as assessed using the Supportive Care Needs Scale

Timepoint [5]

Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [6]

Patient self efficacy as assessed using Patient Activation Measure

Timepoint [6]

Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [7]

Patient in-hospital care experience as assessed using Picker Patient Experience Questionnaire

Timepoint [7]

At 3 and 6 months after intervention commencement

Secondary outcome [8]

Patient health service use (True NTH and non- True NTH Resource use), as assessed by a questionnaire designed for this prostate cancer survivor patient group capturing hospital, medical, pharmaceutical use and days out of role due to ill health to be costed in the economic evaluation.

Timepoint [8]

Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [9]

Carer quality of life as assessed using EQ-5D-5L and Assessment of Quality of Life Multi-Attribute Utility Instrument

Timepoint [9]

Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [10]

Carer health service use (True NTH and non- True NTH Resource use), as assessed by a questionnaire designed for carers of this prostate cancer survivor patient group capturing the carer’s hospital, medical, pharmaceutical use and days out of role due to ill health and carer duties to be costed in the economic evaluation.

Timepoint [10]

Baseline, and at 3 and 6 months after intervention commencement

Eligibility

Key inclusion criteria

Patients will be eligible for the study if they:
1) have been diagnosed with localised prostate cancer within the previous 3 months; OR
2) have been diagnosed with localised prostate cancer within the previous 12 months and are undergoing active surveillance or radiation treatment
3) are diagnosed with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment
4) are able and willing to participate in the intervention and to complete patient reported outcome assessments.
5) Nominate a general practitioner who then agrees to use CDMnet.

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded from the study if they:
1)are too unwell (as determined by treating clinician)
2)have physical, psychological or cognitive difficulties that would prevent them from participating in the interventions or completing self report 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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/05/2015

Actual

7/05/2015

Date of last participant enrolment

Anticipated

Actual

15/11/2016

Date of last data collection

Anticipated

15/05/2017

Actual

30/05/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Movember Foundation

Address [1]

233 Punt Road, Richmond, Victoria 3121

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Patsy Yates

Address

Centre for Healthcare Transformation
Queensland University of Technology
60 Musk Ave
Kelvin Grove
Queensland 4059

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rob Carter

Address [1]

Deakin Health Economics
Deakin University
Building BC, 221 Burwood Highway
Burwood
Victoria 3125

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro North Hospital and Health Service - The Prince Charles Hospital Human Research Ethics Committee

Ethics committee address [1]

Building 14, Rode Road, Chermside, Queensland 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/10/2014

Ethics approval number [1]

HREC/14/QPCH/191

Ethics committee name [2]

North Coast NSW Human Research Ethics Committee

Ethics committee address [2]

PO BOX 821
Murwillumbah
NSW 2484

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

02/04/2015

Ethics approval number [2]

NCNSW HREC No: LNR100

Summary

Brief summary

This study aims to implement and evaluate the feasibility of an integrated care model for prostate cancer patients that incorporates both local and centralised services.

You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with localised prostate cancer within the previous 3 months, OR diagnosed with advanced prostate cancer for at least 12 months.

All patients in this study will be provided with local and centralised prostate cancer support services. These include Care Coordination, Information Provision and Decision Support, Practical Support, Peer Support, Lifestyle Plan, Speialised Support Services, and Advanced Prostate Cancer Comorbidities Management. While each component of the intervention is available for all participants, the intervention and each of its components are tailored to the patient’s stage of disease and their health related needs. Delivery of specialised support services will depend on resource availabililty, access, treating specialist /team preference and preference of the patient.

Patients in this study will be asked to complete 3 surveys over a 6 month period (at the commencement of participation, followed by 3 and 6 months after the commencement of participation) in order to assess their quality of life, prostate cancer symptoms and mental health. In addition, service and carer-related outcomes will be measured. At 6 months after the commencement of participation, patients, carers and key personnel involved in delivering the intervention will be invited to complete an online survey and participate in individual interviews.

This is a pilot study focused on determining feasiblity of a larger randomised study. If the intervention is effective, men with prostate cancer will have access to evidence based supportive care interventions that will contributed to improved health outcomes and quality of life.

Trial website

http://au.movember.com/programs/prostate-cancer

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Patsy Yates

Address

Centre for Healthcare Transformation Queensland University of Technology 60 Musk Ave Kelvin Grove Queensland 4059

Country

Australia

Phone

+61 7 31385780

Fax

[email protected]

Contact person for public queries

Name

Prof Patsy Yates

Address

Centre for Healthcare Transformation Queensland University of Technology 60 Musk Ave Kelvin Grove Queensland 4059

Country

Australia

Phone

+61 7 3138 5780

Fax

[email protected]

Contact person for scientific queries

Name

Prof Patsy Yates

Address

Centre for Healthcare Transformation Queensland University of Technology 60 Musk Ave Kelvin Grove Queensland 4059

Country

Australia

Phone

+61 7 31385780

Fax

[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?

Individual participant data of published results only.

When will data be available (start and end dates)?

The data will be available after publication of the study results.
As per ethics approval for the study, the data will be available for 15 years after completion of the study.

Available to whom?

The IPD will be available only to researchers who provide a methodologically sound proposal, case-by-case basis.

Available for what types of analyses?

The IPD will be available only to researchers who provide a methodologically sound proposal, case-by-case basis.

How or where can data be obtained?

By contacting the Principal Investigator of the study (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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Yates, P., Carter, R., Cockerell, R., Cowan, D., D... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	An integrated multicomponent care model for men affected by prostate cancer: A feasibility study of TrueNTH Australia.	2021	https://dx.doi.org/10.1002/pon.5729

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically