Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000301763
Ethics application status
Approved
Date submitted
16/11/2021
Date registered
17/02/2022
Date last updated
22/02/2022
Date data sharing statement initially provided
17/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Utilization and evaluation of a clinical pathway for managing anxiety and depression in cancer patients
Scientific title
Ramsay Anxiety and Depression Pathway program: Implementation and pilot evaluation of a sustainable and supported clinical pathway for managing anxiety and depression in cancer patients
Secondary ID [1] 305813 0
None
Universal Trial Number (UTN)
Trial acronym
Ramsay ADAPT
Linked study record
ACTRN12617000411347 - this record is an adaption of this study into a private health setting
ACTRN12616000184471 - this record is an adaption of this study into a private health setting

Health condition
Health condition(s) or problem(s) studied:
Anxiety 324327 0
Depression 324328 0
Cancer 324955 0
Condition category
Condition code
Mental Health 321819 321819 0 0
Anxiety
Mental Health 321820 321820 0 0
Depression
Cancer 321821 321821 0 0
Any cancer
Public Health 322384 322384 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients (ADAPT) will be implemented into routine care at Ramsay Health Care Lake Macquarie Private Hospital. Implementation strategies to support adherence to the Clinical Pathway into routine care will be provided.

The ADAPT Portal is 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 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 Ramsay Psychology, Charlestown services when required.

Data extracted from the ADAPT Portal will report on adherence, capturing for each patient, whether they received the ADAPT CP components (screening, triage conversation, referral, referral uptake check, progress review, discharge summary, and rescreening) appropriate for their level of anxiety and depression.

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 written 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, specifically developed for ADAPT. These patient information materials will also link to existing patient/caregiver resources about cancer-related anxiety and depression. Patients may access these resources at their own discretion with no minimum engagement required.

The ADAPT Portal tracks patient access to resources.

iii. 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 self-directed online modules including written information, short videos and activities are available in the ADAPT Portal for patient self-referral or clinician referral. Each session will take patients approximately 45-60 minutes to complete.

Data extracted from the ADAPT Portal will allow for monitoring of patients access to and completion of the online therapy modules.

iv. Online Health Professional Education Modules
Five 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. Modules take approximately 30-45 minutes to complete and incorporate a mix of written information, short videos and interactive activities. The online modules will be delivered to staff over a five week period in facilitated sessions. 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.

As online health professional educations modules will be undertaken during facilitated sessions, completion of these modules will be monitored.

Ramsay Health Care Lake Macquarie Private Hospital cancer service staff will also receive the following implementation strategies:
During the engagement period (6 months prior to ADAPT Portal go live) ADAPT Program staff will work with the site to identify local champion(s) to provide initial training and support. ADAPT Portal and Clinical Pathway Champions will provide the Portal and Clinical Pathway training to hospital staff and be the point of contact for Ramsay Health Care Lake Macquarie Private Hospital cancer service staff who have questions when implementing the ADAPT Portal and Clinical Pathway. These staff will be trained on the ADAPT Portal and Clinical Pathway in a half-day group workshop, with ongoing support provided via telephone/email.
Roadshow and poster campaigns to inform cancer service staff about the Clinical Pathway and the Portal. The poster campaign will be freely accessible to all staff and viewed throughout the hospital at staff discretion. The roadshow presentation will be held at the hospital at a suitable time for majority of staff and made available online for those staff unable to attend.
All staff will be trained to use the Portal, in face-to-face training, by engaging with User Guides and by seeking the support of the Local Champion. This half-day training workshop will be provided by the Champion with assistance from the ADAPT Program staff and will take place in the month leading up to the Portal and Clinical Pathway go live date.
Reports will be provided to site Leads and Champions regarding use of the Portal and the Clinical Pathway issues and concerns.
Intervention code [1] 322634 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329576 0
The primary outcome is adherence to the clinical pathway. Adherence to the ADAPT Clinical Pathway will be measured using a study developed measure of adherence, capturing information about screening, information provision, emotional support, triage, referral, uptake and progress review from site level data (extractions from the portal). This purposefully designed adherence measure comprises key elements of the clinical pathway. The measure items identify whether key elements are present (1) or absent (0) within the specified domains. Items are totalled and transformed to give a continuous score from 0 – 100 for individual patients over the 6-month study period. Patients for whom a score of at least 70 is achieved on the adherence to the Clinical Pathway measure at the endpoint of the implementation phase will be considered adherent. Adherence data will be collected at the end of the implementation period.

A small number of cancer service staff will be asked to participate in a semi-structured interview to explore key domains of acceptability, adoption, appropriateness, feasibility, fidelity, penetration, and sustainability of the ADAPT Portal and Clinical Pathway and its implementation at the beginning and end of the implementation period.
Timepoint [1] 329576 0
Data assessing adherence will be collected the end of the 6-month implementation period.
Secondary outcome [1] 403089 0
Evaluate the feasibility and acceptability of implementing the ADAPT Portal and Clinical Pathway into routine care in a private cancer service in Australia. This will be measured by cancer service staff perspectives on the acceptability, appropriateness, and feasibility of the ADAPT Portal and Clinical Pathway.

Cancer service staff will be asked to complete an online survey via REDCap at the beginning and end of the implementation period. At the beginning of the implementation period cancer service staff will complete an online survey capturing demographic information, qualifications, experience, and work-related duties related to psychosocial care of patients with cancer. Additionally, cancer service staff will complete an online survey at the beginning and end of the implementation period including the following measures:
• 12 statements measuring adoption and feasibility of implementing the Clinical pathway. Staff respond a 5-point Likert scale ranging from 1 agree to 5 disagree
• 12 statements measuring the feasibility and appropriateness of the Clinical Pathway. Staff respond on a 5-point Likert scale ranging from 1 strongly agree to 5 strongly disagree
• 7 items measuring competence/confidence in treating depressed/anxious cancer patients using a 5-point Likert scale ranging from 1 fully agree to 5 do not agree at all
• 5 items measuring acceptability of the Portal and Clinical Pathway using a 5-point Likert scale ranging from 1 fully agree to 5 do not agree at all
• 16 items measuring the penetration of the ADAPT Portal and Clinical Pathway implementation strategies, with participants responding Yes/No/Don’t know
• 16 items measuring the appropriateness of the ADAPT Portal and Clinical Pathway implementation strategies. Response options range from 1 very useful to 4 not at all useful, including 5 Not applicable
A small number of cancer service staff will be asked to participate in a semi-structured interview to explore key domains of acceptability, adoption, appropriateness, feasibility, fidelity, penetration, and sustainability of the ADAPT Portal and Clinical Pathway and its implementation at the beginning and end of the implementation period.
Timepoint [1] 403089 0
Qualitative and quantitative data will be collected pre- and immediately post-implementation of the ADAPT Portal and Clinical Pathway.
Secondary outcome [2] 405079 0
Evaluate the feasibility and acceptability of implementing the ADAPT Portal and Clinical Pathway into routine care in a private cancer service in Australia. This will be measured by cancer service patient perspectives on the acceptability, appropriateness, and feasibility of the ADAPT Portal and Clinical Pathway.
Timepoint [2] 405079 0
A sub-set of patients will be asked to participate in interviews at the end of the implementation period to determine patient acceptability of the ADAPT Portal and Clinical Pathway - screening process, referrals and resources.

Eligibility
Key inclusion criteria
Lake Macquarie Private Hospital 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
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 questionnaire and interviews is voluntary

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
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Ramsay Health Care Lake Macquarie Private Hospital cancer service 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 Portal and Clinical Pathway are also excluded.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a demonstration study being implemented in one site - Ramsay Health Care Lake Macquarie Private Hospital cancer service.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
1/03/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21111 0
Lake Macquarie Private Hospital - Gateshead
Recruitment postcode(s) [1] 35967 0
2290 - Gateshead

Funding & Sponsors
Funding source category [1] 310161 0
Charities/Societies/Foundations
Name [1] 310161 0
Ramsay Hospital Research Foundation
Country [1] 310161 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 311248 0
None
Name [1] 311248 0
Address [1] 311248 0
Country [1] 311248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309850 0
Ramsay Health Care NSW/VIC Human Research Ethics Committee
Ethics committee address [1] 309850 0
Ethics committee country [1] 309850 0
Australia
Date submitted for ethics approval [1] 309850 0
16/11/2021
Approval date [1] 309850 0
15/12/2021
Ethics approval number [1] 309850 0
2021-015-LNR

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

Contacts
Principal investigator
Name 115602 0
A/Prof Joanne Shaw
Address 115602 0
Level 6, Chris O’Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006
Country 115602 0
Australia
Phone 115602 0
+61 2 9351 3761
Fax 115602 0
Email 115602 0
[email protected]
Contact person for public queries
Name 115603 0
Nicci Bartley
Address 115603 0
Level 6, Chris O’Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006
Country 115603 0
Australia
Phone 115603 0
+61 2 86275551
Fax 115603 0
Email 115603 0
[email protected]
Contact person for scientific queries
Name 115604 0
Nicci Bartley
Address 115604 0
Level 6, Chris O’Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006
Country 115604 0
Australia
Phone 115604 0
+61 2 86275551
Fax 115604 0
Email 115604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To be discussed with Steering Committee


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.