Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000509561
Ethics application status
Approved
Date submitted
9/04/2024
Date registered
24/04/2024
Date last updated
24/04/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising a group exercise service for people with cancer
Scientific title
Optimising a group exercise service for people with cancer
Secondary ID [1] 311917 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 333505 0
Condition category
Condition code
Cancer 330181 330181 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Key stakeholders will be interviewed in semi-structured focus groups or interviews (duration 60 mins) to understand their experience with advice about exercise and referral to exercise services after a cancer diagnosis. The stakeholders in question will be people with lived experience of cancer (anyone with a cancer diagnosis, irrespective of stage or type of cancer and treatment trajectory). And healthcare professionals who interact with these people. This includes primary care clinicians (oncologists, haematologists, cancer nurses, in patient allied health care professionals) and exercise professionals who deliver exercise services to people with cancer (exercise physiologists and physiotherapists). each stakeholder group will be in separate groups, for example, people with lived experiences in groups together, cancer clinicians in groups together and exercise professionals in groups together.
Intervention code [1] 328383 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337935 0
Barriers, facilitators and perceptions of exercise and beliefs about exercise. These will be assessed as a single composite measure
Timepoint [1] 337935 0
Single observation
Secondary outcome [1] 434162 0
experiences with exercise referral pathways
Timepoint [1] 434162 0
single observation

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study include:
>/= 18 years, AND,
Any sex, AND,
English speaking, AND
Currently living in NSW AND
Able to give informed consent, AND
People with a diagnosis of cancer, any type and stage, OR,
Clinicians treating people with cancer (oncologist, haematologist, cancer nurse, GP),
OR,
Exercise professional (Accredited exercise physiologist/ physiotherapist) who work with people who have cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People without a cancer diagnosis or health professionals who do not treat people with a diagnosis of cancer
People who cannot give informed consent
People who do not have access to a device with internet acces to enable a video or phone call.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This project uses a mixed methods approach including the use of qualitative and quantitative data collection, and the experience based co-design framework [1] involving consultation with healthcare workers and people with lived experience of cancer.
Experience based co-design (EBCD) involves consultation with both service providers and service users, and actively involves these groups as co developers of the intended intervention [2]. This framework acknowledges that service users and providers are uniquely placed to provide insight into the suitability of health service models. EBCD has been increasingly employed in health service research, particularly in studies with an implementation focus [3].

Once the focus group data is collected, Braun and Clarkes thematic analysis method [4] will guide the qualitative data analysis, using an inductive approach. Interviews will be transcribed and coded, line by line, in NVivo (v12.6.0, Lumivero, Denver, CO). Codes will be organised into themes and subthemes and emergent themes will be summarised and discussed.

[1] Matthews, E., M. Cowman, and S. Denieffe, Using experience-based co-design for the development of physical activity provision in rehabilitation and
recovery mental health care. J Psychiatr Ment Health Nurs, 2017. 24(7): p. 545-552.
[2] Australian Healthcare & Hospital Association (AHHA), Experience based co-design toolkit. 2018.
[3] Fylan, B., et al., Using experience-based co-design with patients, carers and healthcare professionals to develop theory-based interventions for safer
medicines use. Res Social Adm Pharm, 2021. 17(12): p. 2127-2135.
[4] Braun, V. and V. Clarke, Using thematic analysis in psychology. Qualitative research in psychology, 2006. 3(2): p. 77-101.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26384 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 42357 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 316263 0
University
Name [1] 316263 0
University of New South Wales
Country [1] 316263 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 318455 0
None
Name [1] 318455 0
None
Address [1] 318455 0
Country [1] 318455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315083 0
The University of New South Wales Committee C
Ethics committee address [1] 315083 0
Ethics committee country [1] 315083 0
Australia
Date submitted for ethics approval [1] 315083 0
17/11/2023
Approval date [1] 315083 0
05/02/2024
Ethics approval number [1] 315083 0
iRECS4389

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

Contacts
Principal investigator
Name 133622 0
Dr Briana Clifford
Address 133622 0
UNSW, Corner of High st and Botany st, Randwick, NSW, Australia, 2031
Country 133622 0
Australia
Phone 133622 0
+61 2 9065 1813
Fax 133622 0
Email 133622 0
[email protected]
Contact person for public queries
Name 133623 0
Briana Clifford
Address 133623 0
UNSW, Corner of High st and Botany st, Randwick, NSW, Australia, 2031
Country 133623 0
Australia
Phone 133623 0
+61 2 9065 1813
Fax 133623 0
Email 133623 0
[email protected]
Contact person for scientific queries
Name 133624 0
Briana Clifford
Address 133624 0
UNSW, Corner of High st and Botany st, Randwick, NSW, Australia, 2031
Country 133624 0
Australia
Phone 133624 0
+61 2 9065 1813
Fax 133624 0
Email 133624 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


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.