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Trial registered on ANZCTR


Trial ID
ACTRN12617000411347
Ethics application status
Approved
Date submitted
10/03/2017
Date registered
22/03/2017
Date last updated
7/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The ADAPT Program to support the management of anxiety and depression in adult cancer patients: a cluster randomised trial to evaluate different implementation strategies.
Scientific title
The ADAPT Program to support the management of anxiety and depression in adult cancer patients: a cluster randomised trial to evaluate different implementation strategies of the Clinical Pathway for Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients.
Secondary ID [1] 291352 0
Nil known
Universal Trial Number (UTN)
U1111-1193-7790
Trial acronym
ADAPT RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 302463 0
Mental Health 302464 0
Condition category
Condition code
Cancer 302026 302026 0 0
Any cancer
Mental Health 302027 302027 0 0
Anxiety
Mental Health 302028 302028 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cluster randomised trial will be used to compare different implementation strategies to embed the 'Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients'* into routine care. Twelve cancer services in New South Wales will be recruited into this study. Six (Arm 1) will be randomised to receive one set of implementation strategies to support adherence to the Clinical Pathway into routine care and six (Arm 2) will be randomised to receive a differing set of implementation strategies to support adherence to the Clinical Pathway into routine care. The implementation strategies are targeted at cancer services and cancer service staff. Randomisation is at the cancer service level only, stratified by large versus small cancer services.
*Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients: Australian Guidelines. Butow, P. et al. Psycho-Oncology, 24 (9) pp 987 – 1001.

The interventions for each study arm include:

1. The ADAPT Portal - an online, integrated management system that allows cancer service staff to operationalise the Clinical Pathway and has the following essential features and functions:
i. Patient Registration, Management and Referral
Cancer service patient details are entered into the Portal by cancer service staff. The Portal generates a screening date for each patient and alerts staff when patients are due to screen. The Portal generates a screening alert for patients every 3-months, and also at key points in their treatment. If a patient screens with high levels of depression and/or anxiety, the Portal alerts staff that the patient requires triage. After triage, the Portal alerts clinical staff as to the relevant step of the Clinical Pathway for each individual patient, and the appropriate referrals and support to offer. The Portal provides standardised templates for referral and feedback to/from mental health services when required.
ii. Patient screening and education materials
When cancer service staff register a patient's details in the Portal, the system generates a log-in for the patient. Patients may then log-in to their own individual pages within the Portal where they are systematically prompted to complete validated screening and assessment questionnaires online. Using their log-in, patients may also access patient information that explains the importance of screening for anxiety and depression, and the process involved for patients in the use of the Clinical Pathway. These patient information materials will also link to existing patient/caregiver resources about cancer-related anxiety and depression.
iii. iCanADAPT Online therapy treatment programs
Two programs delivering online psychological therapy have been developed by the ADAPT Program for patients with early stage or advanced stage cancer identified as having symptoms of anxiety and/ or depression. The therapy includes behavioural activation, cognitive restructuring and problem solving, attentional training and mindfulness strategies, completed in 6-8 sessions over 10-12 weeks. These online courses are available in the ADAPT Portal for patient self-referral or clinician referral. Patients who access these courses will be monitored by a clinical psychologist.
iv. ADAPT Online Health Professional Education Modules
Online education modules have been developed using evidence-based learning principles and spaced education to promote interactive learning. This education targets screening, assessing severity, making a referral - particularly when patients are reluctant - and empathic communication. Staff will be prompted to undertake annual refreshers by the portal. Modules will be available on eviQ, the most widely used Oncology education site in Australia, with links in the ADAPT Portal

All sites will receive full access to the ADAPT Portal and training to use the Portal resources and systems. The study arms will differ as to the extent to which they receive the following implementation strategies (interventions):
2. Academic Detailing and Support: Initial staff training and support about the Clinical Pathway and use of the ADAPT Portal. Tailoring of the ADAPT Portal set up to fit individual service requirements, service and staff profile.
3. Awareness Campaigns: Roadshow and poster campaigns to inform cancer service staff about the Clinical Pathway and the Portal.
4. Champions: ADAPT program staff will work with sites to identify and support local Clinical Pathway and Portal Champions.
5. Education: Staff will be trained to use the Portal, in face-to-face training and also by engaging with User Guides and by seeking the support of the Local Champion.
6. Reporting: Reports will be provided to site Leads and Champions regarding use of the Portal and the Clinical Pathway issues and concerns.
DELIVERY

All interventions and available ongoing support throughout the study duration will be delivered by experienced health service research professionals, with train the trainer approaches for some aspects during a two-month site engagement and preparation period prior to services initiating implementation of the Clincial Pathway over a 12-month period.

ADHERENCE MEASURES
The primary endpoint of this study is adherence to the Clinical Pathway. This outcome will be measured using a study-developed measure, capturing information about screening, information provision, emotional support, triage, referral, uptake and progress review, as specified in the Clinical Pathway. Adherence will be calculated as a percentage of patients at each site whose care is considered adherent to the Clinical Pathway. This is based on individual calculations for each patient of a continuous score of 0-100 of appropriate critical components of the Clinical Pathway provided over the 12-month study period, transformed into a binary score of adherent or not adherent. This data will be obtained from patient records (with patient consent).

Intervention code [1] 297380 0
Treatment: Other
Comparator / control treatment
Arm 1 of this study is an active control group. They will receive a set of strategies as well as the described resources in order to implement the Clinical Pathway. Arm 2 will receive a differing set of strategies, but the same resources in order to implement the Clinical Pathway.
Control group
Active

Outcomes
Primary outcome [1] 301367 0
Adherence to the Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients.

The primary outcome of adherence will be measured using a study-developed measure, capturing information about screening, information provision, emotional support, triage, referral, uptake and progress review, as specified in the Clinical Pathway. Adherence will be calculated as a percentage of patients at each site whose care is considered adherent to the Clinical Pathway. Adherence information required for the measure will be collected from the patient medical records.
Timepoint [1] 301367 0
Endpoint: 12 months after intervention commences.
Secondary outcome [1] 332499 0
Proportion of cancer patients reporting anxiety and/or depression

Assessed via Portal patient data on levels of anxiety and/or depression. Anxiety and depression are assessed using validated screening tools: firstly, the Distress Thermometer is used and if patients rate over a defined threshold for anxiety and/or depression, the system is prompted to ask them to fill out the Hospital Anxiety and Depression Scale (HADS).
Timepoint [1] 332499 0
Midpoint: 6 months after intervention commences - proportion of patients registered in the Portal reporting anxiety and/ or depression at any point over the 6 months
Endpoint: 12 months after intervention commences - proportion of patients registered in the Portal reporting anxiety and/or depression at any point over the 12 months
Secondary outcome [2] 332500 0
Levels of anxiety and depression and allocation of patients with cancer to clinical, sub-clinical and non-clinical categories of anxiety and depression by staff.
(composite secondary outcome)

Assessed by analysing concordance between patient self-identified symptoms of anxiety and depression to staff confirmation of level of anxiety and depression using data from the Portal.
Timepoint [2] 332500 0
Midpoint: 6 months after intervention commences i.e. concordance between patient screening result and staff triage assessment of patient at each screening event for each patient in first 6 months
Endpoint: 12 months after intervention commences i.e. concordance between patient screening result and staff triage assessment of patient at each screening event for each patient over the second 6 months.
Secondary outcome [3] 332755 0
Secondary Health Economic outcomes:
Costs: (1) to develop and maintain resources which support Clinical Pathway implementation,

Assessed by estimating staff time and costs of employment to develop and maintain resources.
Timepoint [3] 332755 0
Mid-point: 6 months after implementation commences
End-point: 12 months after implementation commences
Secondary outcome [4] 332756 0
Secondary health economic outcomes:
Costs: (2) to put implementation strategies into effect

Assessed by estimating staff (clinical staff and ADAPT support team) time and employment costs in implementing strategies.
Timepoint [4] 332756 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [5] 332757 0
Secondary Health Economic outcomes:
Costs: (3) of screening for and managing anxiety and/or depression using the ADAPT Portal.

Assessed by estimating clinical staff time and costs of employment to incorporate clinical pathway into routine care.
Timepoint [5] 332757 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [6] 332758 0
Clinical Pathway outcomes (1) acceptability of Clinical Pathway by cancer service staff

Assessed by staff surveys (Organisational Readiness for Change Questionnaire and Hands 4U Questionnaire) and key informant interviews.
Timepoint [6] 332758 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [7] 332759 0
Clinical Pathway outcomes (2) adoption of Clinical Pathway by cancer service staff

Assessed by Portal data showing staff uptake of online training, screening events, referral types and user numbers.
Timepoint [7] 332759 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [8] 332760 0
Clinical Pathway outcomes (3) feasibility of Clinical Pathway within cancer service

Assessed by key informant interviews, review of site profile, registration of staff and patients in Portal, user numbers, user activity and repeat screenings.
Timepoint [8] 332760 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [9] 332761 0
Clinical Pathway outcomes (4) appropriateness of Clinical Pathway as deemed by cancer service staff

Assessed by key informant interviews
Timepoint [9] 332761 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [10] 332765 0
Clinical Pathway outcomes (5) fidelity to Clinical Pathway as implemented by cancer services and ADAPT staff

Assessed by comparing records on actual implementation (via contact log, observational diary and strategy checklist) to planned implementation as detailed in Implementation Strategy Plan and Checklist.
Timepoint [10] 332765 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [11] 332773 0
Clinical Pathway outcomes (6) penetration of Clinical Pathway as implemented by cancer services

Assessed via patient registrations in Portal and key informant interviews.
Timepoint [11] 332773 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [12] 332775 0
Clinical Pathway outcomes (7) sustainability of Clinical Pathway as implemented by cancer services

Assessed via key informant interviews and review of contact log and observational diary notes.
Timepoint [12] 332775 0
Mid-point: 6 months after intervention commences
End-point: 12 months after intervention commences
Secondary outcome [13] 332835 0
Patterns of referral before and after introduction of the Clinical Pathway


Assessed by comparing referral patterns and volumes before the intervention using data supplied by the cancer services to patterns and volumes during and after the intervention using Portal data.
Timepoint [13] 332835 0
Baseline: Referral patterns in 4 months before intervention commencement
Midpoint: 6 months after intervention commences
Endpoint: 12 months after intervention commences
Secondary outcome [14] 332836 0
Patterns of referral uptake before and after introduction of the Clinical Pathway


Assessed by comparing referral uptake patterns and volumes before the intervention using data supplied by the cancer services to patterns and volumes during and after the intervention using Portal data.
Timepoint [14] 332836 0
Baseline: Referral patterns in 4 months before intervention commencement
Midpoint: 6 months after intervention commences
Endpoint: 12 months after intervention commences
Secondary outcome [15] 332837 0
Planned versus actual use of implementation strategies, specifically: use of ADAPT Portal.

Assessed via number of patients registered over 12 months compared to patient population over 12 months, and by number of staff members to use Portal compared to total number of possible users.
Timepoint [15] 332837 0
Midpoint: 6 months after intervention commences
Endpoint: 12 months after intervention commences
Secondary outcome [16] 332838 0
Planned versus actual use of implementation strategies, specifically: utilisation of ADAPT team support

Assessed via contact log: meeting attendance, calls received, emails received and support requests received.
Timepoint [16] 332838 0
Midpoint: 6 months after intervention commences
Endpoint: 12 months after intervention commences

Eligibility
Key inclusion criteria
This study has 3 groups of research participants:
1. Group 1 is the site
2. Group 2 is the staff at the participating sites
3. Group 3 is the patients at the participating sites.

Group 1: Cancer services (sites)
Cancer services in New South Wales are eligible to participate providing they commit to the following:
1. Formally agree to participate at the site level
2. Sign an ADAPT Research Participation Agreement
3. Endorse and enable staff training
4. Allow a complete site profile audit
5. Allow release of their Organisational Chart
6. Authorise release of MBS/PBS provider information and statistics

Sites will be required to have the following IT infrastructure:
1. Wi-Fi/broadband/internet access
2. Internet browser version to comply with Portal requirements

Sites will be required to have the following characteristics:
1.. At least 50% of patient population have cancer
2. At least 100 active patients
3. At least 1 IT liaison contact person
4. At least 1 local champion

Group 2: Cancer service staff
1. Employed on an ongoing (6 months or more) or permanent basis, either full or part time or as a visiting medical officer at a participating centre
2. Work in a role that provides clinical care to patients with cancer or client focused administrative support or IT/managerial support.
3. Aged 18 years and over
4. Staff will be identified as part of the organisation chart mapping exercise at site engagement.
5. Participation in giving feedback is voluntary

Group 3: Patients
1. Recruitment for this study will be at the site level so any patients seen at participating sites will be exposed to the outcome of the intervention as part of their usual care.
2. Adult patients (aged 18 and over) who have cancer of any type will be offered screening as part of their routine care by cancer service staff.
3. Patients choose whether to take part in screening or not.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1: Sites
Cancer services who are unable to commit to the mandatory study components will be excluded.
Group 2: Staff
Casual staff, and any staff member under the age of 18 are unable to take part.. Staff who have no clinical or administrative contact with cancer patients, and IT staff who are not involved in the implementation of the ADAPT RCT are also excluded.
Group 3: Patients
Patients who do not consent to sharing their MBS and PBS data will not be included in secondary outcome analyses.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be held by an off-site independent randomisation service and not revealed to the ADAPT Program Staff to maintain blinding until completion of baseline data collection. Once baseline data collection is complete for each site, randomisation outcome will be revealed to ADAPT Program Staff only, and not revealed to study sites. Sites will remain blinded for the duration of the study. Allocation concealment will be preserved, such that the research team will not know what the next randomisation will be.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites who have agreed to participate as indication by completion of the ADAPT Research Participation Agreement will be pre-randomised in blocks.
Sites will be randomised to either Arm 1 or Arm 2, stratified by size (large vs. small) to ensure equal patient volume in study arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size questions have been answered at the site level. i.e. we aim to recruit 12 cancer services to this cluster RCT. We anticipate each site to include approximately 10 cancer service staff, with approximately 6000 patients consenting to their medical record and Medicare data being accessed for analysis over the 12 month period across all sites.

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)
NSW

Funding & Sponsors
Funding source category [1] 295825 0
Government body
Name [1] 295825 0
Cancer Institute of New South Wales
Address [1] 295825 0
8 Central Ave
Eveleigh
Sydney
NSW 2015
Country [1] 295825 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Psycho-oncology Co-operative Research Group (PoCoG)
Address
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
119-143 Missenden Road
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 294747 0
None
Name [1] 294747 0
Address [1] 294747 0
Country [1] 294747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297108 0
Royal Prince Alfred (RPA) Ethics Committee
Ethics committee address [1] 297108 0
Research Governance and Ethics Office
Royal Prince Alfred Hospital
Camperdown
NSW 2050
Ethics committee country [1] 297108 0
Australia
Date submitted for ethics approval [1] 297108 0
31/08/2016
Approval date [1] 297108 0
23/11/2016
Ethics approval number [1] 297108 0
X16-0378 & HREC/16/RPAH/522

Summary
Brief summary
This research study aims to evaluate the level of implementation support required to achieve adherence to the Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients.

Who is it for?
Cancer services in New South Wales may be eligible to participate in this study.

Study details
Cancer services enrolled in this study will be randomised (allocated by chance) to one of two sets of strategies and resources which they must use to implement a Clinical Pathway. The Clinical Pathway describes how cancer patients with anxiety and depression should be identified, supported, referred to appropriate care, and monitored over time.

Strategies and resources
1. The Portal: an online management system for registering cancer patients for screening, assessment, referral and monitoring. The Portal alerts staff when screening and re-screening is due, and to the appropriate level of stepped care for the patient. The Portal has patient pages where patients may log-in and complete screening as well as access information and online therapy for depression and anxiety. The Portal links to online cancer-related anxiety and depression screening education and training modules for staff.

All sites will receive full access to the ADAPT Portal and training to use the Portal resources and systems. The study arms will differ as to the extent to which they receive the following implementation strategies (interventions):
2. Academic Detailing and Support: Initial staff training and support about the Clinical Pathway and use of the ADAPT Portal. Tailoring of the ADAPT Portal set up to fit individual service requirements, service and staff profile.
3. Awareness Campaigns: Roadshow and poster campaigns to inform cancer service staff about the Clinical Pathway and the Portal.
4. Champions: ADAPT program staff will work with sites to identify and support local Clinical Pathway and Portal Champions.
5. Education: Staff will be trained to use the Portal, in face-to-face training and also by engaging with User Guides and by seeking the support of the Local Champion.
6. Reporting: Reports will be provided to site Leads and Champions regarding use of the Portal and the Clinical Pathway issues and concerns.

This study will enable us to determine the level and type of support required by cancer services to introduce the Clinical Pathway, the costs associated with the resources required and the levels of identified anxiety and depression in patients with cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73002 0
Prof Phyllis Butow
Address 73002 0
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
119-143 Missenden Road
University of Sydney
NSW 2006
Country 73002 0
Australia
Phone 73002 0
+61 2 9351 2859
Fax 73002 0
Email 73002 0
phyllis.butow@sydney.edu.au
Contact person for public queries
Name 73003 0
Dr Heather Shepherd
Address 73003 0
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
119-143 Missenden Road
University of Sydney
NSW 2006
Country 73003 0
Australia
Phone 73003 0
+61 2 8627 0828
Fax 73003 0
Email 73003 0
heather.shepherd@sydney.edu.au
Contact person for scientific queries
Name 73004 0
Dr Heather Shepherd
Address 73004 0
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6, Chris O'Brien Lifehouse (C39Z)
119-143 Missenden Road
University of Sydney
NSW 2006
Country 73004 0
Australia
Phone 73004 0
+61 2 8627 0828
Fax 73004 0
Email 73004 0
heather.shepherd@sydney.edu.au