Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000358943
Ethics application status
Approved
Date submitted
11/02/2020
Date registered
13/03/2020
Date last updated
13/03/2020
Date data sharing statement initially provided
13/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring brief exercise counselling and an exercise referral pathway implemented by the cancer care workforce
Scientific title
The feasibility of a brief exercise counselling and an exercise referral pathway implemented by the cancer care workforce
Secondary ID [1] 300295 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 315885 0
Side effects associated with cancer treatment 316144 0
Condition category
Condition code
Cancer 314162 314162 0 0
Any cancer
Public Health 314833 314833 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed as a feasibility trial to explore the implementation of a pragmatic physical activity (PA) communication and referral pathway approach utilised by cancer care clinicians-CCC (i.e., oncologists, oncology nurses) with their cancer patients. Qualitative research methods (e.g. semi-structured interviews) will be utilised to assess the feasibility and acceptability of this approach.

Firstly, during appointments with participating patients (i.e., those who have provided informed consent), CCCs will undertake a 1-2 minute face-to-face conversation about PA/exercise and the important role it plays as part of the patient’s cancer treatment. During this brief time period, the CCC will also provide participants with information about, and contact details of, an exercise physiologist (EP) and indicate that the EP would contact the patient directly by phone to further discuss PA/exercise options and the formal referral process (i.e., GP referral needed to access Medicare rebate). Given the pragmatic nature of this trial and the variability of patients (i.e., cancer type, stage, treatment, etc.) the information provided by the CCCs during the brief 1-2 minute conversation will vary, however the themes surrounding this conversation will focus on the health benefits of PA/exercise specific to that patient and the cancer they are living with, and the impact that PA/exercise may have on side effects and long term survivorship. For the purposes of the current study, the PA communication and referral pathway approach is complete once the EP contacts the patient to discuss exercise options and the formal referral process (i.e., testing and data collection of the approach will only include all communication up to this point), however as part of usual care, patients may choose to extend discussions or book an appointment with the EP, however no data will be collected regarding this. The EP will take note of the number of patients they call, the number of those who engage in the discussion and the number of those who choose not to engage in the discussion. They will also make note of anyone who may inquire about booking a future appointment with the EP.

Participants (both CCCs and patients) will be invited to participate in a voluntary, semi-structured telephone interview concerning the feasibility and acceptability of the PA communication and referral pathway approach. The duration of the interview will be approximately 30-40 minutes and it will be conducted by a research assistant trained in qualitative research methods.
Intervention code [1] 316570 0
Behaviour
Intervention code [2] 316814 0
Lifestyle
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322546 0
Examine CCC and patient perceptions concerning the feasibility of a brief physical activity (PA) communication and referral pathway approach.

A 30-40 minute semi-structured telephone interview will be used to assess feasibility.
Timepoint [1] 322546 0
30 Days

NOTE: rolling data collection (based on rolling recruitment) will occur over a 30 day period, thus data will be collected at various times throughout the 30 day time period.
Secondary outcome [1] 379846 0
Examine CCC and patient perceptions concerning satisfaction, confidence, and importance of the brief physical activity (PA) communication and referral pathway approach.

These are a composite of outcomes which will be assessed within the 30-40 minute semi-structured telephone interview.
Timepoint [1] 379846 0
30 Days

NOTE: rolling data collection (based on rolling recruitment) will occur over a 30 day period, thus data will be collected at various times throughout the 30 day time period.

Eligibility
Key inclusion criteria
1. Cancer care clinicians-CCCs (e.g., oncologists, oncology nurses, and general practitioners) working at St. George Hospital, local public hospital in Sydney, New South Wales, Australia.
2. Cancer patients/survivors of the participating CCCs, as outline in criteria #1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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
Thematic analysis, as outlined by Braun and Clark (2006), will be used to analyse the interview data. Data analyses will be conducted by two trained researchers (UTS research team members) who will independently read the transcripts numerous times to become familiar with the data and generate initial codes by identifying important features of the data that are relevant to the study aims. Coded data will then be examined for similarities, grouped, and refined to identify potential themes. All data management, coding and analysis will be conducted at UTS by UTS research team members.

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77–101.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/04/2020
Actual
Date of last participant enrolment
Anticipated
12/05/2020
Actual
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15629 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 29032 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 304706 0
Other Collaborative groups
Name [1] 304706 0
Translational Cancer Research Network
Country [1] 304706 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Human Performance Research Centre
Faculty of Health
Sport and Exercise Sciences
University of Technology Sydney
Moore Park Precinct, 2021

Driver Avenue, Moore Park NSW 2021
PO Box 123. Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 305021 0
None
Name [1] 305021 0
N/A
Address [1] 305021 0
N/A
Country [1] 305021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305132 0
UTS Human Research Ethics Committee
Ethics committee address [1] 305132 0
Ethics committee country [1] 305132 0
Australia
Date submitted for ethics approval [1] 305132 0
13/01/2020
Approval date [1] 305132 0
26/02/2020
Ethics approval number [1] 305132 0

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

Contacts
Principal investigator
Name 99354 0
A/Prof Cristina Caperchione
Address 99354 0
UTS Sport and Exercise Science
Driver Avenue, Moore Park NSW 2021
Country 99354 0
Australia
Phone 99354 0
+61 029514 5208
Fax 99354 0
Email 99354 0
[email protected]
Contact person for public queries
Name 99355 0
Elizabeth Marin
Address 99355 0
UTS Sport and Exercise Science
Driver Avenue, Moore Park NSW 2021
Country 99355 0
Australia
Phone 99355 0
+61 029514 5210
Fax 99355 0
Email 99355 0
[email protected]
Contact person for scientific queries
Name 99356 0
Elizabeth Marin
Address 99356 0
UTS Sport and Exercise Science
Driver Avenue, Moore Park NSW 2021
Country 99356 0
Australia
Phone 99356 0
+61 029514 5210
Fax 99356 0
Email 99356 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 for this study will be kept confidential in non-identifiable format. The identifier code will only be available to study investigators. All data presented or disseminated will be in aggregated form.


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.