Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000574549
Ethics application status
Approved
Date submitted
17/04/2024
Date registered
7/05/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Using Digital Humans to Deliver Stress Management: Feasibility and Acceptability to Women with Breast Cancer and Healthcare Professionals.
Scientific title
Using Digital Humans to Deliver Stress Management: Feasibility and Acceptability to Women with Breast Cancer and Healthcare Professionals.
Secondary ID [1] 311427 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress following breast cancer active-treatment 333580 0
Condition category
Condition code
Cancer 330235 330235 0 0
Breast
Mental Health 330339 330339 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CBSM:
Participants will complete one module of Cognitive Behavioural Stress Management (CBSM; Antoni, 2003) Therapy delivered by a digital human. This module will take place at the University of Auckland Clinical Research Centre. Participants will complete this module of CBSM in a private room on a secure University computer screen. This CBSM session includes psychoeducation surrounding the effects of stress on the body and mind, and involves learning a stress management technique: deep breathing. The digital human uses a conversational engine (IBM Watson Agent) to power her conversation flows. The CBSM module is developed from Antoni’s (2000) manual for CBSM in breast cancer patients.

The digital human is called Rosie, delivering this module of CBSM therapy via a computer screen. Rosie, the digital human being used in this study was modelled to be a female adult providing relatability to the target population. Rosie is presented wearing a white T-shirt and upon a lightly pink background, so her face and communication abilities are of central focus on the screen. During sessions, her natural body movements are paired with natural facial expressions, depending on the topic of conversation and in response to the user’s expression. Text-to-speech Emotional Markup Language (EML; Sagar et al., 2014; Sagar et al., 2016) is utilised to allow Rosie to display certain facial expressions, such as a smile, when she mentioned certain phrases or words, such as affirmative statements. Her voice was programmed to have an Australian ‘Neural’ accent, with natural inclinations and pronunciation used within New Zealand society, making her more applicable to the target population.
Participants will verbally or text to communicate with the digital human Rosie. The session will last for a duration of approximately 60-minutes, with the natural conversation/session length becoming a marker for intervention adherence.
Intervention code [1] 328433 0
Treatment: Other
Comparator / control treatment
As this research is a feasibility and acceptability study, there is no control condition or treatment being administered.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338007 0
Feasibility
Timepoint [1] 338007 0
Practicality of recruitment will be assessed upon the conclusion of the study. This will be assessed when recruitment targets have been met, and data collection has been completed.

Technical difficulties will be assessed throughout the session and immediately post-intervention by the researcher noting how many difficulties are encountered during and after the session.

Coverage of measures will be assessed upon conclusion of the study, once recruitment targets have been met and data collection is complete.
Primary outcome [2] 338008 0
Acceptability
Timepoint [2] 338008 0
Immediately post-Intervention.
Secondary outcome [1] 434104 0
Trust
Timepoint [1] 434104 0
Immediately post-Intervention.
Secondary outcome [2] 434527 0
Rapport
Timepoint [2] 434527 0
Immediately post-intervention.
Secondary outcome [3] 434528 0
Present Moment Stress
Timepoint [3] 434528 0
At baseline and immediately post-intervention.
Secondary outcome [4] 434529 0
Present Moment Relaxation
Timepoint [4] 434529 0
At baseline and immediately Post-Intervention

Eligibility
Key inclusion criteria
Participants will either be a women who has experienced breast cancer a minimum of two years prior to the study start date, or a healthcare provider working within cancer-related or Cognitive Behavioural Therapy (CBT) related spaces.

Key Inclusion Criteria for Group one (BCp):
Group one (BCp) will consist of females aged 18 years or older who have finished active treatment for breast cancer a minimum of two years prior to the study start date. Participants must be fluent in English and comfortable using a computer.

Key Inclusion Criteria for Group two (HCp):
Participant group two (HCp) will consist of healthcare providers aged 18 years or older working within cancer-related and/or CBT spaces. Participants must be fluent in English and comfortable using a computer. Can be male of female.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from participation if they do not meet the above inclusion criteria or are not willing to participate.

Study design
Purpose of the study
Educational / counselling / training
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
Statistical methods / analysis
A minimum of 30 participants is recommended for a feasibility and acceptability study (Teresi et al., 2022).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2024
Actual
9/06/2024
Date of last participant enrolment
Anticipated
30/08/2024
Actual
12/08/2024
Date of last data collection
Anticipated
30/08/2024
Actual
19/08/2024
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 26249 0
New Zealand
State/province [1] 26249 0

Funding & Sponsors
Funding source category [1] 315701 0
University
Name [1] 315701 0
University of Auckland
Country [1] 315701 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318503 0
None
Name [1] 318503 0
Address [1] 318503 0
Country [1] 318503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314568 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 314568 0
Ethics committee country [1] 314568 0
New Zealand
Date submitted for ethics approval [1] 314568 0
22/01/2024
Approval date [1] 314568 0
12/04/2024
Ethics approval number [1] 314568 0
AH27228

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

Contacts
Principal investigator
Name 132042 0
Dr Elizabeth Broadbent
Address 132042 0
Department of Psychological Medicine, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country 132042 0
New Zealand
Phone 132042 0
+64 93737599
Fax 132042 0
Email 132042 0
[email protected]
Contact person for public queries
Name 132043 0
Cerys Clayden
Address 132043 0
Department of Psychological Medicine, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country 132043 0
New Zealand
Phone 132043 0
+64 278836702
Fax 132043 0
Email 132043 0
[email protected]
Contact person for scientific queries
Name 132044 0
Elizabeth Broadbent
Address 132044 0
Department of Psychological Medicine, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country 132044 0
New Zealand
Phone 132044 0
+64 93737599
Fax 132044 0
Email 132044 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
Data is confidential.


What supporting documents are/will be available?




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.